Modern Sterile Product Manufacture â€“ Exploring Best Practices

www.pdaannualmeeting.org 1

April 15-17, 2013 | The Peabody Orlando | Orlando, FloridaCareer Fair: April 15-16 | Exhibition: April 15-16

Post-Conference Workshop: April 17-18 | Courses: April 18-19

The Parenteral Drug Association presents the...

Modern Sterile Product Manufacture –

Exploring Best Practices and Seeking New Approaches

April 15-17, 2013The Peabody Orlando

Orlando, Florida

www.pdaannualmeeting.org Exhibition: April 15-16 | Career Fair: April 15-16


This preliminary agenda is current as of December 6, 2012.

Register before February 1, 2013 and save up to $400.

Information on the post-conference workshop, 2013 PDA Human Factors & Human Error Reduction Workshop, “Application

to Pharmaceutical Manufacturing and

Quality Environments,” inside!

2 www.pdaannualmeeting.org

Connecting People, Science and Regulation®

Program Planning Committee

Co-Chair: Co-Chair:

Hal Baseman Maik Jornitz ValSource, LLP G-Con Manufacturing, LLC

Ursula Busse, PhD Novartis Pharma AG

Michele Creech Grifols, Inc.

Bob Dana PDA

Ian Elvins Lonza Biologics

Jose Goin, PhD Genentech, Inc.

Jeffrey Hartman Merck and Company

Stephanie Ko PDA

Rickey Lu MedImmune, LLC

Miguel Montalvo Expert Validation Consulting, Inc.

Wanda Neal PDA

Miguel Nogueras Abbott Medical Optics (AMO)

Michael Sadowski Baxter Healthcare

Emily Shacter, PhD ThinkFDA, LLC

Brent Watkins Veltek Associates, Inc.

“The 2012 PDA

Annual Meeting was

well organized with

excellent speakers.

The presentations

covered the key

topics of parenteral

manufacturing

and production of

biopharmaceuticals.”

Friedrich Haefele, Boehringer-Ingelheim Pharma




A Message from the Program Co-Chairs

As with all of our Annual Meetings, this year’s conference

is a science and technology based event. The 2013 PDA Annual Meeting specifically focuses on advances in modern

manufacturing, the challenges currently faced by the industry,

and the challenges that we will face in the next few years.

There are three basic tracks of papers, biological science

systems, sterile product manufacturing, and quality. Within those

tracks we’re tackling new subjects and areas of focus, as well as

subjects that the industry has been facing for several years.

It’s a very unique meeting because it will show a glance into

the future of the industry. This meeting has a variety of different

options where you can cherry-pick the different areas you want

to know about. The industry and our members want to know

what’s happening in the future and trends which are occurring.

The entire industry is in a shift to ore efficiency; legacy models

don’t work any longer. When you look at the competitive

pressure which is happening then you have to change your

technology perspective. And besides that the industry desires

to become faster, more flexible and scalable. The conference

addresses the desires by showing up-coming process and

product technologies.

Some of the areas that will be presented on are single use

systems, new investigation techniques, drug shortages,

counterfeiting, biosimilars, and innovative methods for sterile

manufacturing. In addition, sessions and presentations will

explore current issues facing our industry.

Understanding that a key issue in the industry over the last few

years has been glass defects and delamination, an important

presentation will explore considerations for manufacturers

seeking to move from glass to plastic containers.

We will also build on some of the more successful efforts

from last year’s Annual Meeting, including a session on career

development, focusing on the tools and approaches one can use

to advance one’s career.

New members and first time meeting attendees will benefit

from the knowledge gained directly from the presentation of

important papers. In addition, attendees will have the valuable

experience of participating in and listening to exchanges during

interactive question and answer sessions. The sessions are

designed for a significant portion to be devoted to question

and answer exchanges. Moderators are encouraged to get

the audience into the conversation, not just ask a couple of

questions and go on, but to really get into a good exchange

of information. This is an education opportunity, as well as a

strong networking opportunity.

There are carefully planned networking and social activities,

where professionals in the industry can meet, in a less formal

manner, and discuss the topics of the day. This is an important

chance for new members to gain more knowledge and get a

better feel for the industry.

From a conference viewpoint, you have a variety of different

topics one can pick and choose from. This Annual Meeting

has a large spread of traditional topics and new, progressive

sessions. You have a basket of opportunity to learn and also to

communicate and to ask questions. That’s something which I

always find invaluable.

Hal Baseman, Chief Operating Officer, ValSource, LLC

Maik Jornitz, Vice President, Business Development, G-Con Manufacturing, LLC

Sunday, April 14 – Monday, April 15, 2013 Agenda

7:30 a.m. - 12:00 noon7th Annual PDA Golf Tournament

8:00 a.m. - 8:00 p.m. Exhibit Set Up

8:00 a.m. - 10:00 am.PDA 7th Annual Walk/Run Sponsored by Sartorius Stedim Biotech

11:00 a.m. - 4:00 p.m. Regulatory Affairs & Quality Advisory Board

2:00 p.m. - 6:00 p.m. Registration Open

3:00 p.m. - 6:00 p.m. Speaker Ready Room Open

3:00 p.m. - 6:00 p.m. Meet and Greet Reception

3:00 p.m. - 4:00 p.m. 2013 Annual Meeting Program Planning Committee Meeting (Invitation Only)

4:00 p.m. - 5:00 p.m. Portfolio Steering Committee Meeting

5:00 p.m. - 6:00 p.m. Interest Group Leaders Meeting

6:30 p.m. - 9:30 p.m. PDA Awards Dinner (Invitation Only)

Monday, April 15, 2013

7:00 a.m. - 5:30 p.m. Registration

7:00 a.m. - 8:00 a.m. Continental Breakfast

7:00 a.m. - 8:00 a.m. New Member Breakfast

7:00 a.m. - 8:30 a.m. PCMO Steering Committee

7:00 a.m. - 5:00 p.m. Speaker Ready Room Open






8:30 a.m. - 8:45 a.m. Welcome, Opening Remarks and PDA Award Announcements

8:45 a.m. - 10:30 a.m. Opening Plenary SessionModerator: Maik Jornitz, Vice President, Business Development, G-Con Manufacturing, LLC

Session Description: PDA’s membership is based on pharmaceutical and biopharmaceutical drug developers and manufacturers, which comply with global regulations to supply safe and efficacious sterile products. To support these efforts, PDA fosters networking, educational and communication opportunities, which bring peer companies, consultants and regulators together to learn, inform and improve.

8:45 a.m. - 9:30 a.m.Keynote: FDA Presenter to be announced

9:30 a.m. - 10:15 a.m.Joyce Bloomfield, Executive Director, Global GMP Systems & Compliance, Merck Sharp & Dohme

10:15 a.m. - 10:30 a.m.Q&A

10:15 a.m. - 7:00 p.m. Exhibit Hall Open

10:30 a.m. - 11:15 a.m. Refreshment Break and Poster Presentations in Exhibit Hall

Monday, April 15, 2013 Agenda (continued)



11:15 a.m. - 12:45 p.m. Concurrent Sessions

Track: Biological Sciences Track: Sterile Product Manufacturing Track: Quality Systems

A – Plant-Made Pharmaceuticals Moderator: Ursula Busse, PhD, Head Project Office, Global Pharmaceutical Operations, Novartis Pharma AG

B – Modular Systems – Facility Consideration Moderator: Jose Goin, PhD, Associate Director, Quality Control Network Operations, Genentech, Inc.

C – Current Trends in Process Validation Moderator: Jeffrey Hartman, Director, Validation Quality Assurance, Merck and Company, Inc.

Description: Pharmaceuticals from genetically modified plants are now at the cusp of reaching the market. This session addresses the scientific, technical and commercial manufacturing aspects of plant-based production systems, with emphasis on quality and regulatory challenges. The first presentation will cover therapeutic protein production in plants using transient expression systems. These systems have been scaled up to commercial production in capacities exceeding 400 kg/year of finished protein product in high containment facilities. A case study will be presented highlighting the development of a large plant-made pharmaceuticals facility in conjunction with the Defense Advanced Research Projects Agency (DARPA), designed for rapid response to a pandemic or biological threat. The second presentation will provide an overview of the development of a genetically engineered carrot cell based manufacturing platform from its earliest days through to an approved therapy for treating Gaucher disease. The presentation will describe some of the development process in bringing this product to market and briefly touch on the company’s pipeline.

Description: Future facility requirements asked for flexibility in regard to capacity variations, multi-product production and potential mobility. Furthermore, more robust containment solutions within facilities or as facilities are necessary to fulfill regulatory needs and protection of the environment. The session will cover both topics in detail.

Flexible modular system will be described in regard to the functionality of either being a unit operation or utilized as assembled product site. Example cases will show the benefits of these modular pods for start-up companies, failed product approval, multi-product or varying capacity production sites. Cytotoxic or highly potent product components are not a rarity any longer. The containment options for cytotoxic product production will be discussed.

Description: Practices and expectations continue to evolve in process validation. This session will focus on two new challenges in process validation, single use systems and Continued Process Verification (CPV). For single use, the presentation will first review the advantages of this technology as it applies to manufacturing. Based on these drivers, a strategy for the qualification / validation of a single use system will be presented, including the challenges that need to be addressed during execution. The session will continue with the challenges of implementing a Continued Process Verification program, aligned with the 2011 FDA guidance on process validation. Applying statistical process control following a standard “text book” approach results in several common real life issues during execution of the CPV program. The presentation will offer some practical solutions to overcome these issues during implementation.

11:15 a.m. - 11:45 a.m.Transient Expression and Commercial Production of Therapeutic Protein in PlantsBarry Holtz, PhD, Chief Science and Technology Officer, Caliber Biotherapeutics

11:45 a.m. - 12:15 p.m.Elelyso – First – In – Class, Approved Recombinant Drug Produced from Plant Cells Karen Ginsbury, CEO, PCI Pharmaceutical Consulting Israel, Ltd.

12:15 p.m. - 12:45 p.m.Q&A

11:15 a.m. - 11:45 a.m.New Modular Production FacilitiesMaik Jornitz, Vice President, Business Development, G-Con Manufacturing, LLC

11:45 a.m. - 12:15 p.m.Cytotoxic Dedicated Facilities Hank Rahe, Technical Director, Enguard Systems

12:15 p.m. - 12:45 p.m.Q&A

11:15 a.m. - 11:45 a.mQualification / Validation of Single Use Systems Christopher Smalley, PhD, Director, Merck Sharp & Dohme

11:45 a.m. - 12:15 p.m.Statistical Issues in Continued Process VerificationJulia O’Neill, Director, Principal Engineer, Merck & Company, Inc.

12:15 p.m. - 12:45 p.m.Q&A





12:45 p.m. - 1:45 p.m. IG Leaders Meeting

12:45 p.m. - 2:15 p.m. Networking Luncheon in Exhibit Hall

12:45 p.m. - 2:15 p.m. Science Advisory Board

2:15 p.m. - 3:45 p.m.Concurrent Sessions


D – Expression Systems for Biopharmaceutical ProductsModerator: Rickey Lu, Director, Manufacturing, MedImmune

E – Innovative Approaches to Sterile Product PackagingModerator: Hal Baseman, Chief Operating Officer, ValSource, LLC

F – Complementing Your Quality Systems with Technology While Meeting New Regulatory Requirements in a Global Market Moderator: Miguel Nogueras, Global Manager, QA, Microbiology, Abbott Medical Optics (AMO)

Description: Protein expression systems are the core of the biopharmaceutical industry. The type of expression system a product has is responsible for a wide range of considerations from manufacturing capacity to patient safety profiles. Significant development efforts have achieved breakthroughs and enhancements of our utilization of expressions systems for the manufacturing of biopharmaceutical products. This session explores the current state of expression system development in regards to two innovative areas, specifically, microbial cultures and the application of cell culture in vaccine manufacturing, including the elusive cell culture based Influenza vaccine.

Description: New products, complex delivery systems, and modern processing technologies create the opportunity and need for innovative approaches to sterile product packaging. In this session, industry experts will discuss current container/closure issues and explore alternative approaches, including case studies and on-going activities, design to meeting these challenges.

Description: Most companies operate in a global environment, which represents a challenge when it comes to compliance. This session will provide you with alternatives to comply with global market requirements for product traceability using serialization and barcoding techniques. In addition we will explore microbiological applications that can lower your operation cost of controlled environments. This session is designed to provide the audience with innovative approaches with potentially cost savings opportunities while remaining compliant in a global environment.

2:15 p.m. - 2:45 p.m.Progress of Cell Culture Based Vaccines (ex. Flu)Fred Porter, PhD, Associate Director, Technology Development, Novartis Vaccines and Diagnostics

2:45 p.m. - 3:15 p.m.Efficient Production of Antibody Fragments in Microbial Cell CulturePeter Steiner, PhD, Head Production and Processes, ESBATech, a Novartis Company

3:15 p.m. - 3:45 p.m.Q&A

2:15 p.m. - 2:45 p.m.Plastic Container Development for Biological ParenteralsRon Forster, Executive Director, Amgen, Inc.

2:45 p.m. - 3:15 p.m.Case Study: Closed Vial/ContainerDebashis Sahoo, PhD, Director, Engineering, Medical Instill Technologies, Inc.

3:15 p.m. - 3:45 p.m.Q&A

2:15 p.m. - 2:45 p.m.Serialization and Bar CodingCyndi Poetker, Sr. Program Manager of Global Standards and Serilization., Abbott Laboratories

2:45 p.m. - 3:15 p.m.Multiple Applications Using A Rapid Microbiology System Including Cost Saving OpportunitiesPeter Noverini, Field Application Scientist, Azbil BioVigilant Systems, Inc. Miguel Nogueras, PhD, Global Manager, QA, Microbiology, Abbott Medical Optics (AMO)

3:15 p.m. - 3:45 p.m.Q&A




3:45 p.m. - 4:30 p.m. Refreshment Break and Poster Presentations in Exhibit Hall

3:45 p.m. - 4:45 p.m. TRI Committee Meeting

4:30 p.m. - 6:00 p.m.Concurrent Interest Groups

IG1Quality Risk Management

Leader: Michael A. Long, PhD, Director and Principal Consultant, ValSource, LLCJeffrey Hartman, Director, Validation Quality Assurance, Merck and Company, Inc.

Description: This year’s IG session will open with a presentation by Dr. Michael Long entitled The Impact of Heuristics and Biases in Risk Management. Heuristics play an important role in risk management, and executing risk assessments. These cognitive behaviors impact and govern decision making and judgments regarding risk. They are also a significant source of error and bias in our decision making. During this session, common heuristics will be explained and tools will be discussed to assist in minimizing their impact on risk assessments.

Following this presentation, Jeffrey Hartman will facilitate a discussion on the recent PIC/S Aide-Memoire, Assessment of Quality Risk Management Implementation. This guidance document was published in March 2012. Together, we will review the five questions posted in the Aide Memoire and collectively determine how effective and well integrated Quality Risk Management is in our companies and industry.

IG2 Biotechnology

Leader:Vince Anicetti, Adjunct Professor, Keck Graduate Institute/PDA Fellow, Science and Regulatory Affairs

Description: The Biotech Interest group will focus on current opportunities and challenges in cellular and gene therapy. The interest group will present an update on the current efforts of the PDA Task Force on Cellular and Gene Therapy. The session will also present the findings of the PDA survey on Bioburden and Biofilm Management along with an update on the status of the Bioburden and Biofilm Management technical report.

IG3 Management on Outsourced Operations

Leader: Karen Ginsbury, CEO, PCI Pharmaceutical Consulting Israel, Ltd.Sue Schniepp, Vice President, Quality and Regulatory Affairs, Allergy Laboratories, Inc.

Description: This interest group is devoted to discussing issues and concerns of contract organizations. The inaugural meeting of this group took place at the PDA/FDA Joint Regulatory Conference in 2012. This second meeting will be a continuation of the initial discussion and will focus on some of the “hot topics” identified by the participants. There will be a presentation on Effectively Handling Audits and Quality Agreements. Karen Ginsbury and Sue Schniepp will lead the discussions.

IG4 Microbiology/Environmental Monitoring

Leader: Jeanne E. Moldenhauer, Vice President, Excellent Pharma Consulting, Inc.

Description: This year we will be talking about some of the changing expectations for media fills. In recent months there have been many new requests from investigators regarding media fills. A panel of subject matter experts will be present to discuss some of these new expectations and how we might respond.

IG5 Pre-filled Syringes

Leader:Thomas Schoenknecht, PhD, Director, Global Key Accounts Management, Schott AG

Description: This session will focus on methods and process ensuring container closure integrity on syringes and drug delivery devices.

IG6 Facilities and Engineering

Leader:Christopher J. Smalley, PhD, Associate Director, BioSterile Validation, Merck Sharp & Dohme

Description: Do More With Less. How often have we heard that mantra, and how often will the burden fall to the Facilities and Engineering Group to make it happen?At this session, we will recap some of the earlier presentations on energy conservation, ‘Green’ energy, use of Single Use Systems, and disposal of Single Use Systems with a focus on the growth of Single Use Systems as a means to improve manufacturing flexibility and reduce water usage and waste. Learn how to ‘Do More With Less.’





IG7 Sterile Processing and Inspection Trends

Leader: Ken H. Muhvich, PhD, Principal Consultant, Micro-Reliance, LLCBob Dana, Senior Vice President Quality and Regulatory Affairs and PDA Training and Research Institute, PDA

Description: The manufacture of sterile products continues to receive a great deal of attention during regulatory inspections. This Interest Group session will review some of the most important points to consider in preparing for regulatory inspections, and provide an overview of a general inspection plan. Significant findings arising from regulatory inspections will also be presented and discussed.

5:30 p.m. - 7:00 p.m. Networking Gala Reception in Exhibit Hall

6:15 p.m. - 7:00 p.m. Alumni Board Reception (Invitation Only)

7:00 p.m. - 8:00 p.m. Chairs Reception (Invitation Only)

Tuesday, April 16, 2013

7:30 a.m. - 5:30 p.m. Registration Open

7:30 a.m. - 5:30 p.m. Speaker Ready Room Open


7:10 a.m. - 8:20 a.m. Roundtable Breakfast Sessions

Breakfast I – BiosimilarsBreakfast II – Case Study: Vaccine

Manufacturing OutsourcingBreakfast III – Newly Engaged Breakfast

Moderator: Brent Watkins, Southeast Regional Sales Manager, Veltek Associates, Inc.

Moderator: Michele Creech, Quality Operations Manager, Grifols, Inc.

Moderator: Richard Johnson, President, PDA

Session Description: The health care product industry is facing changes and challenges as a result of innovative products, new technologies, expanded supplier networks, and the growing needs of public health. New approaches will be needed as the traditional methods may not offer the optimal approach to process design, manufacturing, process control, quality assurance, and regulatory compliance. How will the industry and regulators change current approaches in order to meet these new challenges? How can industry and regulators work together to make these changes and develop these new approaches? How can industry and regulators anticipate the challenges they may face

Session Description: Pfizer concluded a major vaccine contract at a CMO, producing Phase III clinical supplies and successfully completing process validation, within an aggressive timeline but without sacrificing quality. Fi will recount the selection process for the CMO, the negotiations for Service and Quality Agreements, and more importantly, the complex technology transfer process for production processes and analytical test methods – what worked and what did not work – and why – lessons learned.

Session Description: You are invited to get involved with PDA as a volunteer. Learn about the many opportunities to serve on a PDA Task Force, Program Planning Committee or Chapter. Would you like to become a member of one or more PDA Interest Groups, speak at an event, or become a PDA TRI Course instructor? This is your chance to learn more and sign-up.

Monday, April 15–Tuesday, April 16, 2013 Agenda

“It has been a very useful and informative

meeting. I appreciate the speakers and the

opportunities to connect with colleagues

in the industry.”

Melanie Tellers, Merck



Breakfast I – Biosimilars (continued)Breakfast II – Case Study: Vaccine

Manufacturing Outsourcing (continued)Breakfast III – Newly Engaged Breakfast

(continued)

and the changes needed to meet those challenges in the future? These and other related issues will be addressed.

Emily Shacter, PhD, ThinkFDA, LLC Firelli Alonso-Caplen, PhD, Senior Director, BioTherapeutics & Vaccines Outsourcing BioTherapeutics Pharmaceutical Sciences, Pfizer, Inc.

Advisory Board Members and IG Leaders will present

Q&A Q&A Q&A

8:00 a.m. - 9:30 a.m. 2014 PDA Annual Meeting Exhibit Space Draw Meeting

8:30 a.m. - 10:00 a.m. Plenary Session 2 – Major Changes to the IndustryModerator: Hal Baseman, Chief Operations Manager, ValSource, LLC

Description: The second plenary session of the meeting is designed to bring all attendees together to discuss topics of upmost and current impact and interest to industry. The primary objective of pharmaceutical business is to provide safe and effective health care products to patients. Therefore, recognizing and addressing threats to the reliability of product supply is essential to maintaining public and regulatory confidence that this objective can be met. To that end, this plenary session will present updates, current thoughts, and discussion from and with those in the industry directly involved with meeting the increasing complex challenges to public trust posed by drug product shortages and product counterfeiting.

8:30 a.m. - 9:00 a.m.Drug ShortagesMarty Nealey, Vice President, Operations, Plant Manager, Hospira Pharmaceuticals, Inc.

9:00 a.m. - 9:30 a.m.Counterfeiting Martin VanTrieste, Senior Vice President, Quality, Amgen, Inc.

9:30 a.m. - 10:00 a.m.Q&A

9:45 a.m. - 4:30 p.m. Exhibit Hall Open

10:00 a.m. - 10:45 a.m. Refreshment Break, Poster Presentations and Passport Raffle Drawing in Exhibit Hall

Tuesday, April 16, 2013 Agenda (continued)




10:45 a.m. - 12:15 p.m.Concurrent Sessions


G – A-Vax: A QbD Case Study and Study Guide Moderator: Emily Shacter, PhD, ThinkFDA, LLC

H – Contemporary Practice in the Manufacture of Sterile ProductsModerator: Michael Sadowski, Director, Sterile Manufacture Support, Baxter Healthcare

I – Outsourcing RelatedModerator: Miguel Montalvo, President, Expert Validation Consulting, Inc.

Description: Five vaccine manufacturers formed a collaboration to prepare a case study to illustrate how QbD could be applied to vaccine development. The intent of the initiative is to help stimulate discussion within industry as well as between industry and regulatory agencies to better understand the challenges associated with attempting to apply QbD to vaccine development and, in turn, understand how these challenges might be overcome. During this session, an overview and case study will be provided with an initial discussion of critical quality attributes and control strategy development on the use of QbD in vaccine development

Description: Terminal sterilization and aseptic processing are the most critical segments of the manufacturing process in the production of sterile biologic, drug and medical device products. Advancements in medical science have led to the development more effective healthcare products and therapies many of which are not stable with conventional terminal sterilization processes. Consequently, alternate terminal sterilization processes or aseptic processes must be employed to ensure sterility for these products. This session will explore the important considerations in the development of novel sterilization processes and then review the application of these in a case study. Additionally, contemporary approaches such as the use of Restricted Access Barrier Systems, Isolators and other advanced aseptic process technologies will be highlighted.

Description: The approval of a Contract Manufacturer is a critical decision and must be taken to the highest level of detail including in-depth audits, agreements, communication strategies, handling of any discrepancies/conflicts and the documentation to be provided to the process owner. The internal procedure must define internal requirements, the selection, initial audits and approval process and the continued monitoring requirements including frequent audits.

Suppliers of ready-to-use components such as sterilized containers/closures, stoppers, single-use bags must be treated with the same level as your most critical process even if full GMP are not required at their manufacturing process. Focus must be placed on the sterilization process and the testing/validation of such.

10:45 a.m. - 11:15 a.m.A/VAX, CMC Vaccine Working Group QbDJohn Finkbohner, PhD, Senior Director, Regulatory Affairs, MedImmune LLC

11:15 a.m. - 11:45 a.m. Case Study: QbD Implementation for Vaccines M. Amin Khan, PhD, Global Head Technical Development and MS&T, Novartis Vaccines and Diagnostics

11:45 a.m. - 12:15 p.m.Q&A

10:45 a.m. - 11:15 a.m.Advanced Sterilization TechniquesPatrick McCormick, PhD, Manager, Research Sterilization, Bausch & Lomb, Inc.

11:15 a.m. - 11:45 a.m. Advancements in Aspectic Processing: Isolators & RABSJames Akers, PhD, President, Akers Kennedy & Associates

11:45 a.m. - 12:15 p.m.Q&A

10:45 a.m. - 11:15 a.m.Outsourcing Contract Facilities ManufacturingIan Elvins, Vice President, Quality, Lonza Biologics

11:15 a.m. - 11:45 a.m. Ready to Use System / Components Gmp SuppliersEdwin Rivera-Martinez, Vice President, U.S. Quality Liaison, Global Quality, Sanofi-Aventis

11:45 a.m. - 12:15 p.m.Q&A

11:00 a.m. - 12:00 p.m. Exhibits Committee Meeting (Invitation Only)

12:15 p.m. - 1:45 p.m. 2014 Annual Meeting Program Planning Committee Meeting (Invitation Only)

12:15 p.m. - 1:45 p.m. Networking Luncheon in Exhibit Hall




12:15 p.m. - 1:45 p.m. Biotechnology Advisory Board Meeting (Invitation Only)

12:15 p.m. - 1:45 p.m. Chapter Council Meeting

1:45 p.m. - 3:15 p.m. Concurrent Sessions – Fundamental Tracks


J – FundamentalsModerator: Stephanie Ko, Senior Manager, Lecture Education, PDA

K – FundamentalsModerator: Bob Dana, Senior Vice President Quality and Regulatory Affairs and PDA Training and Research Institute, PDA

L – FundamentalsModerator: Miguel Montalvo, President, Expert Validation Consulting, Inc.

Description: Biotechnological and biological therapeutic products are often manufactured using materials of animal or human origin and the risk of contamination by known or unknown pathogens exists. Regulatory agencies worldwide require a demonstration of viral safety for these products. This session will address virus-removal filters, which are specifically designed to remove viruses and other biomolecules. Virus filtration is a complement to virus inactivation, both of which contribute to virus clearance.

In addition, the session will include principles and practical applications for the preparation and testing of high quality virus spikes. There will be a discussion of the quality attributes that need to be tested and controlled in virus spikes so that they can be used in representative scale down validation studies.

Finally, this session will address concepts to consider when implementing a Single Use System (SUS) strategy in a pharmaceutical manufacturing process. A comparison will be made of single use technology over multi-use technology in determining the most appropriate manufacturing strategy, and the potential impact of a SUS on product quality will be discussed.

Description: This session will cover two important elements impacting the quality of finished pharmaceutical products. Process equipment used to manufacture pharmaceutical products intended to be sterile must be properly cleaned and sanitized or sterilized prior to use. This session will address the technology associated with steaming of process equipment, including the design and validation of steam in place cycles. A second presentation will address the important concepts associated with visually inspecting each container of finished drug product to ensure the absence of visible particulates and cosmetic defects.

Description: An emerging trend has been occurring in process validation in the past few years. A new draft regulatory guidance on process validation has been issued by the EMA (European Medicines Agency) and comments were due October 2012. The FDA finalized their guidance in January 2011. A comparison of the traditional and continuous process verification approaches to process validation will be described. The similarities and differences of the various international guidance documents and practices, both regulatory and non-regulatory will be described.

Statistics will play a critical role in all stages of the Process Validation Lifecycle approach. Stage 3 provides the greatest and higher impact application of these tools to better control our processes and be more preventive in our efforts.

1:45 p.m. - 2:15 p.m.Virus Filtration & SpikeDamon Asher, PhD, Senior Scientist Virology & Microbiological Sciences, EMD Millipore Corporation

2:15 p.m. - 2:45 p.m.Single Use SystemsRobert Repetto, Senior Director, Pfizer, Inc.

1:45 p.m. - 2:15 p.m.Visual Inspection of Injectable ProductsJohn G. Shabushnig, PhD, Senior Manager, Team Leader, Pfizer, Inc.

2:15 p.m. - 2:45 p.m.Steam In PlaceKevin Trupp, Principal Consultant, Sterilization Technology and Compliance

1:45 p.m. - 2:15 p.m.Process Validation: CMPC Guidance – Comparison to EMA Process Validation Guidance (Continued Process Verfication)Scott Bozzone, PhD, Quality Systems and Technical Services – Validation, Pfizer, Inc.

2:15 p.m. - 2:45 p.m.TR Foundation: Statistics & Process ControlGreg Flexman, Process and Risk Analysis, Grifols, Inc.





Track: Biological Sciences (continued)Track: Sterile Product Manufacturing

(continued)Track: Quality Systems (continued)

2:45 p.m - 3:15 p.m.Q&A

2:45 p.m - 3:15 p.m.Q&A

2:45 p.m - 3:15 p.m.Q&A

3:15 p.m. - 4:00 p.m. Refreshment Break, Poster Presentations and Passport Raffle Drawing in Exhibit Hall

4:00 p.m. - 5:30 p.m.Concurrent Interest Groups

IG8 Process Validation

Leader:Scott Bozzone, PhD, Senior Manager, Global QO Validation, Pfizer, Inc.Hal Baseman, Chief Operations Officer, ValSource, LLC

Description: There will be presentation and discussion on the latest hot topic in process validation at the time. For example, we hope to have the FDA regulatory agency feedback to how the industry is reacting to the 2011 guidance on process validation. The lifecycle approach, measuring the consumer and manufacturer risk levels in Stage 2 and 3 of the lifecycle could be other topics. Also, we hope to have the EMA’s (European Medicine Agency) resolution to the comments due Oct 2012, on the Draft PV Guidance of March 2012. This Guidance has several sterile products and aseptic processing statements.

Finally, there will be time allotted for open discussion. We can share and benchmark with one another in the industry on these topics.

IG9 Vaccines

Leader: Frank S. Kohn, PhD, President, FSK Associates, Inc.

Description: The Vaccines Interest Group (VIG) focuses on issues that affect the biological, biotechnology, and vaccine industry. The Interest Group has previously discussed regulatory issues, new technologies, and emerging industry trends. Recent issues include vaccine availability and supplies, homeland security, and inspection trends.

IG10 Pharmacoepial

Leader:Janeen Skutnik-Wilkinson, Director, Quality & Regulatory Policy, Pfizer, Inc.Karen Ginsbury, CEO, PCI Pharmaceutical Consulting Israel, Ltd.

Description: This interest group is devoted to discussing issues and current concerns related to pharmacopeias. The inaugural meeting of this group took place at the PDA/FDA Joint Regulatory Conference in 2012.

This second meeting will be a continuation of the initial discussion and will focus on some of the “hot topics” identified by the participants.

IG11 Visual Inspection of Parenterals

Leader: John G. Shabushnig, PhD, Senior Manager, Quality Systems and Technical Services, Pfizer, Inc.

Description: We will review recent FDA 483 observations as well as recall activity related to visual inspection defects. We will also review progress on development of USP General Chapter <790> Visible Particulates in Injections. We will use this opportunity to discuss plans to update the PDA benchmarking survey of visual inspection practices. We have conducted this study three times in the past at approximately 5-year intervals and we are due to revisit this topic. We will also use this opportunity to share discussions from the EU Visual Inspection IG meeting scheduled for late March 2013 with Annual Meeting attendees. As in past meetings, we will use any remaining time for open discussion of inspection topics of interest to those in attendance. Past topics have included inspector training and qualification, validation of automated inspection systems, the use of standards to assess inspection performance, new inspection technologies and the unique inspection challenges of biopharmaceuticals.




IG12 Packaging Science

Leader: Edward J. Smith, PhD, Principal Consultant, Packaging Science Resources

Description: This session will provide an update of PQRI Parenteral & Ophthalmic Drug Products Extractables & Leachables Working Group, a review of USP Elemental Impurities Chapters – USP 232 and USP 232, as well as, an overview of the recent advances in the packaging of Cold Chain Products

IG13 Lyophilization

Leader:Edward H. Trappler, President, Lyophilization Technology, Inc.

Description: As lyophilization is a constantly developing field there are always new perspectives in the science, technology and compliance realms. This interest group provides an open forum for discussions on current topics. Topics are identified at the onset of the meeting for open discussions among participants. The informal forum provides a unique opportunity to learn from a variety of experiences and perspectives and provides an excellent benchmark for current industry practices. Bring current topics of interest to you for discussion with your peers.

You can read highlights on past sessions in the July/August issue of the PDA Letter.

IG14 Filtration

Leader: Russell E. Madsen, President, The Williamsburg Group, LLC

Description: The PDA Filtration Interest Group will meet in conjunction with the PDA 2013 Annual Meeting. The Interest Group will meet on Tuesday, April 16 from 4:00 p.m. to 5:30 p.m. Speakers representing Meissner, Millipore, Pall and Sartorius have been invited to speak on topics including retention of mycoplasma and small microorganisms and optimizing the total cost of ownership for membrane filtration. There will be time for general discussion of topics of interest in addition to the formal presentations.

Speakers:Optimizing Total Cost of Ownership for Membrane FiltrationMandar Dixit, Director, Marketing & Product Management – Filtration Technologies, Sartorius-Stedim Biotech

Retention of Mycoplasma and Small Microorganisms Lia Jeffrey, Microbiological Scientist III, EMD Millipore Corporation

Safety Considerations for Gas Filtration in High Temperature & Oxygen Enrichment ApplicationsMonica Cardona, Marketing Manager, Global Air / Vent Product Manager, Pall Corporation

Mycoplasma Task Force Filtration Subgroup UpdateLeesa McBurnie, Manager, Laboratory Services and Validation, Meissner Filtration Products, Inc.

6:30 p.m. - 9:00 p.m.PDA Dine Around

Wednesday, April 17, 2013

7:00 a.m. - 1:00 p.m. Registration Open

7:00 a.m. - 11:15 a.m. Speaker Ready Room Open


Tuesday, April 16–Wednesday, April 17, 2013 Agenda

“This year’s conference was superb! The

topics were cutting edge, informative, and thought

provoking. They really drove home the successes and

challenges we all face in our day to day work.”

Michele Creech, Grifols Therapeutics, Inc.




7:10 a.m. - 8:20 a.m. Breakfast Session

Breakfast IV- Career Development Strategies Moderator: Vince Anicetti, Adjunct Professor, Keck Graduate Institute/PDA Fellow, Science and Regulatory Affairs

Description: Strategies and tips for advancing your career will be discussed by respected and highly experienced experts in biopharmaceutical recruiting and leadership development. The session will use a panel discussion format addressing audience questions. Don’t miss this opportunity to understand todays demanding job market from some of the industry experts in career and leadership development.

Panel Participants Tony Hurley, Head of Quality Biologics Drug Product Operations, Genentech, Inc. Ira Mann, Director of Quality, Validation, and Regulatory Affairs Executive Search, FPC (Fortune Personnel Consultants) of AtlantaMary Lavin, President, Sartorius Laboratories, Sartorius Stedim North America, Inc.

8:30 a.m. - 10:00 a.m. Concurrent Sessions


M – Viral Safety StrategiesModerator: Michele Creech, Quality Operations Manager, Grifols, Inc.

N – Advances in Single-use Technology ApplicationsModerator: Maik Jornitz, Vice President, Business Development, G-Con Manufacturing, LLC

O – Conducting an Effective Investigation Moderator: Ian Elvins, Vice President, Quality, Lonza Biologics

Description: The concept of Viral Safety is a moving target in the Biologics Industry. As knowledge of viral contaminants grows, so does the need for ensuring the safety of commercial products derived from biological sources. Therefore the assessment and mitigation techniques implemented today must ensure the safety of tomorrow’s products, while acknowledging the need to prevent potential contamination by as yet unknown or unidentified viral risks.

The potential for viral contamination has always been a risk to the commercial biological products industry. Viral contamination may originate from source material or be introduced as incidental contamination during production processes. Viral risk assessments and state of the art technologies, including nanofiltration, have emerged as rational, scientific and technological methods for mitigating this risk. Viral risk assessments are critical to identifying potential virus safety risk events in the manufacture of biological products.

Description: Single-use equipment and technology becomes increasingly employed. Single-use hold and mixing bags, filtration systems and connectors are widely used for many years. However, final technology hurdles in this area were filling and sensor technologies, both critical to the product quality at the end-point and as process monitoring tool. These “white fields” of single-use applicability are now getting covered by new technological advances and innovations. In this session, we will learn about medium to large scale precision filling using single-use systems, which avoid the need of cleaning and assembly. Sensor technology advances are critical to determine the process stability and support PAT. Again, these sensors are sort d for as single-use equipment. The described advances are platforms to build on further innovations.

Description: Despite sound process design and planning, unwanted events may still occur. Properly investigating these events and process failures, identifying process failure causes, and determining corrective and preventive actions are therefore an essential element of an effective Quality System program. This session will present discussions on recent and important case studies, updates, and effective tools for conducting and closing investigations.

Wednesday, April 17, 2013 Agenda (continued)



Wednesday, April 17, 2013 Agenda (continued)

Track: Biological Sciences (continued)Track: Sterile Product Manufacturing

(continued)Track: Quality Systems (continued)

These risk assessments must take into consideration the challenges presented by the likelihood that viral contamination would occur and be detected. Mitigation strategies are necessary to reduce and/or eliminate viral contamination in these products. Evaluating and selecting an effective viral inactivation system can be a challenge since experience in this arena is constantly evolving. Dr. Osherhoff and Dr. Ziegler will provide information on both of these innovative strategies during this session.

8:30 a.m. - 9:00 a.m.Viral Risk Assessment & ScreeningWendy Osheroff, PhD, Section Head, Pathogen Safety Support and ComplianceGrifols, Inc.

9:00 a.m. - 9:30 a.m.Techniques for Viral Risk MitigationThierry Ziegler, PhD, Head of Bioprocesses, Sanofi-Aventis

9:30 a.m. - 10:00 a.m.Q&A

8:30 a.m. - 9:00 a.m.Single Use for Final FillingDave Cousins, Director, Sales North America, Bosch

9:00 a.m. - 9:30 a.m.Advances in PAT Single-Use Sensors and Emerging TechnologiesGovind Rao, Professor / Director, Center for Advanced Sensor Technology, University of Maryland Baltimore County

9:30 a.m. - 10:00 a.m.Q&A

8:30 a.m. - 9:00 a.m.Case Study: Follow Up on Leptospira Contamination Anders Vinther, PhD, Vice President, Quality Biologics, Genentech, Inc.

9:00 a.m. - 9:30 a.m.Case Study: Finding the Root Cause in an Investigation Johnnie Williams, Director, Quality Engineering/Quality Systems, DSM Pharmaceuticals, Inc.

9:30 a.m. - 10:00 a.m.Q&A

10:00 a.m. - 10:30 a.m. Refreshment Break

10:30 a.m. - 12:15 p.m. Closing Plenary Session – Focus on the Future Moderator: Ursula Busse, PhD, Head Project Office, Global Pharmaceutical Operations, Novartis Pharma AG, Co-Chair, 2014 Program Planning Committee

10:30 a.m. - 11:00 a.m.T-Cell Immunotherapy to Cure CancerCarl June, MD, Program Director, Translation Research, Professor, Department of Pathology & Laboratory Medicine, University of Pennsylvania Abramson Cancer Center

11:00 a.m. - 11:30 a.m.The Future of Personalized MedicineIndustry Presenter to be Announced

11:30 a.m. - 12:15 p.m.Panel Discussion




12:15 p.m. Closing Remarks and Adjournment Jose Goin, PhD, Associate Director, Quality Control Network Operations, Genentech, Inc., Co-Chair, 2014 Program Planning Committee

12:30 p.m. - 5:00 p.m. PDA Board of Directors Meeting

Thursday, April 18, 2013

8:00 a.m. - 12:00 p.m. PDA Board of Directors Meeting

Wednesday, April 17–Thursday, April 18, 2013 Agenda

www.pda.org/humanfactors2013


Despite advances in automation, pharmaceutical operations continue to involve the human – machine interface. As many internal investigations point out, human error continues to be a major causative factor. The challenge in advancing pharmaceutical operations is to reduce the potential for errors. During the Human Factors and Human Error Reduction Workshop different tools will be presented to be used in conjunction with quality system tools that may allow managing improvements in operations as process re-design may be an outcome of an investigation taking Human Factors under consideration.

Who Should Attend

• Quality Engineering/Assurance / Risk Management• Manufacturing supervision• Process Engineering/Improvement• Operational Excellence

Contact

Workshop Inquiries:Wanda Neal Senior Vice President, Programs and Registration ServicesTel: +1 (301) 656-5900 ext. 111Email: [email protected]

Exhibition/Sponsorship Inquiries: David HallVice President, Sales Tel: +1 (301) 656-5900 ext. 160 or cell +1 (240) 688-4405Email: [email protected]

Registration Hours:

Wednesday, April 17, 20137:30 a.m. – 5:30 p.m.

Thursday, April 18, 20137:00 a.m. – 4:00 p.m.

Session and Presentation Topics:

• The Impact of Human Factors on Pharmaceutical Manufacturing• Cognitive Processing: Attention Span• Human Factors during Process Design• The Myths Regarding Warnings and Labels• Process Design and HF Considerations• Ergonomics• Process Equipment and Facilities

2013 PDA Human Factors and Human Error Reduction WorkshopApplication to Pharmaceutical Manufacturing and Quality EnvironmentsThe Peabody Orlando, Orlando Florida | April 17-18, 2013


Save $100 when you register for this Workshop

and the 2013 PDA Annual

Meeting!

www.pda.org/humanfactors2013




Sunday, April 14, 2013

7:00 a.m. – 12:00 p.m.7th Annual PDA Golf Tournament– Optional event

Join us for a “hole” lot of fun at Shingle Creek Golf Club. Enjoy the elegance and history of the course while surrounded by the Florida Everglades. This award winning course allows you to customize your game with five sets of tees, while the layout of the course will allow you to challenge your skills and that of your opponents. Spend your morning on the greens networking with co-workers, colleagues and friends.

$155.00 per person; price includes cart, green fees, practice and range balls, refreshments and lunch. 8:00 a.m. – 10:00 a.m. PDA 7th Annual Walk/Run – Optional event Sponsored by Sartorius Stedim BiotechTo Benefit the Base Camp Children’s Cancer Foundation

On your mark, get set, GO—to the 7th Annual Walk/Run event with your colleagues, family and friends. 100% of your donations go to the Base Camp Children’s Cancer Foundation to help benefit and impact the lives of the patients and their families. Start the week off with your heart rate up, your body energized, and taking in the fresh air at the 3K walk and 5K run through the beautiful Turkey Lake Park.

Transportation will depart from the Peabody Orlando Hotel at 7:15 a.m.

$30 per registered attendee or guest; price includes transportation, a pedometer, t-shirt, race bib, snacks and beverages (water, juice).

Monday April 15, 2013 and Tuesday, April 16, 2013

PDA Annual Meeting Career Fair Exhibit/Sponsorship Opportunities

Exhibit at the PDA Annual Meeting Career Fair to interact with highly qualified job seekers from a variety of fields in the biopharmaceutical science and manufacturing industry. With a 10’ x 10’ booth and dedicated exhibit hall hours, you can showcase your company, employment opportunities, and brand identity to hundreds of attendees seeking to advance their careers. Ample time will be provided for you to solicit resumes, screen candidates, and conduct on site interviews. Sponsoring the PDA Career Fair is an excellent way to generate exposure and recognition for your company. Our sponsorship packages allow you to brand your company as an elite place to work as well as promote company events, products, and services.

For more information, please contact David Hall at +1 (240) 688-4405 or [email protected].

Networking Events

It’s all about balance so make your conference experience a well-rounded one by participating in networking activities that help jump start your connection with your peers in the industry.

Want to win an iPad?!

PDA will send you a pedometer upon the completion of your registration for the walk/run event. Please use the pedometer to monitor your steps. Whoever has tracked the most steps by race day will win an iPad! Don’t forget to bring your PDA issued pedometer.



PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Following full attendance, completion and submission of the appropriate evaluation forms, certificates will be

mailed within four to six weeks of the event. Continuing Education Units (CEUs) will be awarded as follows:

2013 PDA Annual Meeting

ACPE #0116-0000-13-095-L04-P | 1.25 CEUs Type of Activity: Knowledge

For course CEUs and ACPE information for individual courses, see pages 22-24

Learning ObjectivesAt the completion of this event, you will be able to:

• Recognize the latest technical advances in personalized medicine, cellular therapies and sterile biopharmaceutical manufacturing

• Identify the challenges in manufacturing and quality assurance/quality control of sterile products

• Describe the future of personalized medicine and biopharmaceuticals

• Explain current regulatory expectations, philosophies and challenges for manufacturing processes and emerging technologies

• Discuss microbiological control in the manufacturing environment for biopharmaceuticals and advanced aseptic technologies

• Interpret case studies highlighting techniques to plan and implement biopharmaceutical process development, manufacturing, testing and distribution procedures using risk- and science-based approaches, LEAN manufacturing approaches, statistical process control, PAT, etc.

• Utilize newly released PDA Technical Reports and use of PDA training programs to improve process development, manufacturing, testing and distribution of sterile products

Who Should AttendAny and all who are involved in the development, manufacture, testing and distribution of regulated drug and healthcare products – including:

Departments: Manufacturing | Quality | Research & Development | Process Development | Regulatory Affairs | Engineering | Laboratory Science | Information Technology | Validation | Training

Job Functions: Executive Management | Mid-level Management | Project Management | Technical Services | Supply Chain | Manufacturing Application | Risk Management | And for those new to their job function, we strongly recommend the Foundations Track

Specialties: Biopharmaceuticals | Personalized Medicine and Advanced Cellular Therapies | Biologicals | Medical Devices | Active Pharmaceutical Ingredients | Combination Products | Nutriceuticals

Continuing Education2013 PDA Annual Meeting Course Series – April 18-19, 2013

Immediately following the conference on Thursday and Friday, PDA’s Training and Research Institute (PDA TRI) will be offering six courses designed to complement what you’ve learned at the conference. All courses will be held on April 18-19, at The Peabody Orlando.

Recommended Practices for Manual Aseptic ProcessesApril 18, 2013 | 8:30 a.m. – 4:00 p.m.PDA #216 | ACPE #0116-0000-12-216-L04-P | 0.6 CEUsType of Activity: Knowledge

Course Description

The goal of aseptic processing operations is to prevent the contamination of materials intended to be sterile. For large scale automated operations, where operator interventions are infrequent, the verification of the ability to produce sterile product is evaluated by the conduct of large scale automated media fills in a manner analogous to normal production.

Processes using all or partial manual procedures must also be evaluated by process verification testing. However, such manual operations present unique operational and evaluation challenges not generally encountered with automated operations. While manual aseptic processes rely heavily on individual operator proficiency, operational personnel and their activities are generally recognized as the greatest source of potential microbial contamination during manual aseptic processes. Reproducible human performance cannot be assumed over time.

These and other challenges posed by manual aseptic processing must be considered when designing the evaluation protocol.

This course will provide valuable practical insights into the technological challenges associated with designing, operating and evaluating manual aseptic processing. Participants will come away with an understanding of how manual aseptic processes differ from automated ones, and what should be addressed as they work with manual aseptic processes in their own plants. They will also learn how process simulation testing to evaluate manual aseptic processing operations should be designed and carried out. Topics such as personnel training and qualification, design of manual aseptic processes and evaluation of manual aseptic processing process simulations will be covered. The course is based on a PDA Technical Report addressing the same subject.




Who Should Attend

This course will be of value to operational personnel who design, carry out and evaluate manual aseptic processing, including personnel involved with compounding, filling, packaging, and quality assurance operations. Support staff, such as engineering and validation personnel, will also benefit. The course will be suitable for supervisors and managers as well as personnel engaged in manual processing operations.

Learning Objectives

Upon the completion of this course, you will be able to:

• Discuss the challenges associated with manual aseptic processing• Describe the elements involved in the design of process simulation

studies for manual aseptic processing• Explain the elements associated with training and qualification

of personnel involved with manual aseptic processing• Explain the differences to be considered when designing

manual aseptic processing operations in unidirectional air flow and in isolators

• Apply the lessons learned to the design and conduct of manual aseptic processing operations to your job

• Design a protocol for the conduct of a process simulation test for manual processing

Instructor

Carol Lampe

Steam In PlaceApril 18, 2013 | 8:30 a.m. – 4:00 p.m.PDA #313 | ACPE #0116-0000-12-313-L04-P | 0.6 CEUsType of Activity: Application

Course Description

This course will enable participants to better understand how design and operational concepts can be applied to optimize (e.g., shorter more lethal cycles) steam in place cycles and also how to apply the most applicable validation approaches. The course will include an interactive lecture along with some hands-on demonstration of various methods for doing temperature mapping and BI placements in piping systems that are steamed in place.

Training will also include some exercises using risk assessment tools to determine if the system to be steamed should be considered “sterilized” or “sanitized,” as that decision has a significant impact on the validation approaches that would be utilized for the initial and

periodic validations performed on the system. The primary objective of the course is gain a better understanding for how to design, operate and validate systems that are steamed in place.

Who Should Attend

This course is for personnel in Process Engineering, Validation and Quality.

Learning Objectives

Upon completion of this course, you will be able to:

• Identify the difference between a system that needs to be “sanitized” or a system that needs to be “sterilized”

• Discuss system design concepts that will enhance the steam in place process

• Describe conditions that can compromise the sterility of a sterilized system

• Explain options for temperature mapping and BI placement (as applicable)

• List the potential Pro’s and Con’s for when to conduct the pre-use filter integrity test

Instructor

Kevin D. Trupp, Principal Consultant – Sterilization Technology and Compliance, Automated Systems Incorporated

Biofilms April 18, 2013 | 8:30 a.m. – 4:00 p.m.PDA #476 | ACPE #0116-0000-12-476-L04-P | 0.6 CEUsType of Activity: Application

Course Description

This course will provide scientific understanding and real world practices for the management of bioburden and biofilm in pharmaceutical and biopharmaceutical production processes. Microbial control of pharmaceutical API and biopharmaceutical drug substance processes are a significant quality and compliance problem today. An extremely difficult to detect bioburden contamination has been recently reported in a major Biotech production facility, and a persistent biofilm problem at another facility recently led to medical supply shortages. Such events have revealed shortcomings in microbial control systems and resulted in increased regulatory concern. The course will review principles and best practices in the design of facilities/utilities/equipment to minimize bioburden with emphasis on the particular challenges of biofilm. The course will also review the best currently available technology and sampling practices for bioburden and biofilm detection, including trend

2013 PDA Annual Meeting Course Series – April 18-19, 2013 (continued)



analysis and decision principles within the quality management system. Best practices in remediation of contaminated processes and equipment will be reviewed with case studies where possible.

Who Should Attend

This course is intended for scientists and technical staff, as well as middle to senior level managers in pharmaceutical and biopharmaceutical Quality Control, Quality Assurance, Regulatory Affairs, Manufacturing and Development.

Learning Objectives


• Discuss the principles and best practices of microbial control in pharmaceutical processes based on current best practices and regulatory expectations

• Explain the biology underlying bioburden development in pharmaceutical and biopharmaceutical drug substance production systems

• Explain the mechanisms surrounding biofilm formation and the complex interactions between that exist between planktonic and sessile modes of microbial contamination

• Provide information on typical control levels/limits for various types and stages of biopharmaceutical production systems, including critical utility systems

• Discuss principles and best practices in prevention, detection, and remediation of microbial contamination in pharmaceutical/biopharmaceutical drug substance or API production systems, including current regulatory guidance and expectations

• Manage microbial quality issues and conduct effective investigations, remediation, and regulatory interactions

Instructors

Vince Anicetti, Adjunct Professor, Keck Graduate Institute (KGI) of Applied Life Sciences and PDA Fellow, Scientific and Regulatory Affairs, PDAPatricia Hughes, Lead Consumer Safety Officer, CDER, FDAMarc Mittelman, PhD, Senior Managing Scientist, Exponent

Single-Use SystemsApril 18, 2013 | 8:30 a.m. – 4:00 p.m.PDA #107 | ACPE #0116-0000-13-107-L04-PType of Activity: Knowledge

Course Description

This course will provide students with critical concepts to consider when implementing a single use system (SUS) strategy in a pharmaceutical manufacturing process. These concepts are intended to be valid both for chemically synthesized small molecules and for bioprocesses that produce large-molecule biopharmaceutical products.

The course will discuss single use systems that are in either direct or indirect contact with raw materials, intermediates, intermediate products, pharmaceutical drug substances or drug products.

Determining the optimal manufacturing strategy involves concepts from many disciplines. An effective evaluation will have a balanced viewpoint, with consideration from engineering, regulatory, quality project management and accounting. Balancing risks and rewards of a single use system (SUS) over a Multiple Use System (MUS) will help determine the most appropriate manufacturing strategy.

Learning Objectives


• Describe the necessary considerations and steps to accomplish a successful evaluation and implementation of a single use strategy

• Define process operating parameters and requirements necessary when examining single use solutions

• Determine potential impact of an SUS on product quality • Compare and contrast single use technology and multi-use technology • Assess risk by considering the potential for the single use system

to interact with product or process fluids• Outline supplier control strategies to ensure successful single use

system implementation• List minimum requirements, impact of different sterilization methods

on materials of construction, and validity of testing approach

Instructor

Robert Repetto, Senior Director, External Affairs, Pfizer, Inc.





Process Simulation Testing for Aseptically Filled ProductsApril 19, 2013 | 8:30 a.m. – 4:00 p.m.PDA #374 | ACPE #0116-0000-12-374-L04-P | 0.6 CEUsType of Activity: Knowledge

Course Description

Process simulation testing is expected as part of a firm’s quality system to ensure the sterility of products manufactured using aseptic processing techniques. The verification of the ability of the process to produce sterile product is evaluated by the conduct of large scale automated process simulation testing (media fills). This course, which is based on a recently revised PDA Technical Report addressing the same subject, will address all the various elements required in the design and execution of a media fill, including personnel qualification, media selection and preparation, filling considerations, interventions, duration and number of units filled, pre and post incubation inspections, incubation conditions, acceptance criteria and investigations and corrective actions. Participants in this course will come away with an up to date understanding of current scientific and regulatory advances in the design, conduct and interpretation of process simulations. The knowledge they gain can be applied immediately to media fill operations in their own jobs. The use of risk-based decision making will be considered.

Who Should Attend

This course will be of value to managers and supervisors involved in the design, operation, evaluation and approval of process simulation testing. This includes persons working in operations, quality assurance, microbiology, and regulatory affairs. Individuals in facility engineering will also benefit from attendance.

Prerequisites

Individuals taking this course should have a basic understanding of aseptic manufacturing operations. This is not a course designed to teach the basic fundamentals of aseptic processing.

Learning Objectives

Upon the completion of this course, you will be able to:

• Identify the updated scientific and regulatory technology and expectations in the design, operation and interpretation of process simulations

• Discuss process simulation concepts and principles such as the number and frequency of simulations, worst case and risk assessment and ongoing evaluations

• Describe how to use risk management as it applies to aseptic processing simulations

• Discuss how process simulations can be applied to various types of aseptically processed products (lyophilized products and powders)

• Explain why environmental monitoring is an important element of process simulations

• Discuss the necessary documentation associated with process simulations

• Apply modern concepts to establish appropriate acceptance criteria for media fills, evaluate the results and, as necessary, investigate any failures and recommend appropriate corrective and preventive actions

Instructor

Hal Baseman, Principal, ValSource and Task Force Co-Leader of PDATechnical Report 22 (Revised 2011); Process Simulation for AsepticallyFilled Products

Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Validation and Ongoing ControlApril 19, 2013 | 8:30 a.m. – 4:00 p.m.PDA #442 | ACPE #0116-0000-12-442-L04-P | 0.6 CEUsType of Activity: Application

Course Description

Moist heat sterilization processes are considered to be “special processes” since the output of the process, product sterility, cannot be fully verified with test methodologies such as the sterility test. Therefore, it is absolutely essential that moist heat sterilization processes be properly designed, validated and controlled. This course will provide a foundational understanding of sterilization science (microbiology and thermal science) that will then be applied in the selection of a cycle design approach, sterilization process development, process performance qualification and ongoing process control. The course is based on the latest revision of PDA’s most popular sterilization reference, PDA Technical Report No. 1, Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control. Since its issuance, it has been widely utilized by industry and regulatory sterilization professionals in the development and assessment of sterilization programs across the globe.

Who Should Attend

Manufacturing Operations, Formulation, Engineering, QA/QC, Product and Process Development, Regulatory Affairs, Research and Development, Sterility Assurance, Technical Operations and Validation Professionals





Learning Objectives


• Discuss microbiology and sterilization science and apply these concepts in the development of a scientifically sound and regulatory compliant sterilization program

• Use a decision tree to select the most appropriate sterilization process based on the attributes of the load type

• Utilize the Semilog Survivor Curve Equation in support of the development and ongoing control of the sterilization program

• Assess risk associated with the cycle phases and identification of key and critical process parameters in the development of the sterilization process for liquid and porous/hard goods loads types

• List the critical elements of process performance qualification

Instructor

Mike Sadowski, Director, Sterile Manufacture Support, Baxter Healthcare

For additional information about the 2013 PDA Annual Meeting training courses, contact: Stephanie Ko, Senior Manager, Lecture Education Tel: +1 (301) 656-5900 ext. 151 | E-mail: [email protected] For registration inquiries please call: +1 (301) 656-5900 ext. 115

Course Schedule

7:30 a.m. Registration Open for Courses

8:30 a.m. – 10:00 a.m. Classroom activity

10:00 a.m. – 10:15 a.m. AM Break

10:15 a.m – 12:00 p.m. Classroom activity

12:00 p.m – 1:00 p.m. Lunch (provided)

1:00 p.m. – 2:30 p.m. Classroom activity

2:30 p.m. – 2:45 p.m. PM Break

2:45 p.m. – 4:00 p.m. Classroom activity




Three Ways to Register

1. Click www.pdaannualmeeting.org

2. Fax +1 (301) 986-1093

3. Mail PDA Global Headquarters Bethesda Towers 4350 East West Highway Suite 150 Bethesda, MD 20814 USA

Venue

The Peabody Orlando9801 International Drive Orlando, FL 32819Phone: +1 (407) 352-4000Website: http://www.peabodyorlando.com/

Make Your ReservationPasskey Link: https://resweb.passkey.com/go/PDA2013

Call-in Numbers: +1-800-PEABODY (732-2639) or (407) 345-4488

Fax Number: +1 (407) 354-1424

Rate: Single – $209.00, plus applicable state and local taxes.

Cutoff Date: The PDA rate is based on availability. Please note that the hotel can sell out prior to the cutoff date of Tuesday, March 5, 2013. (Rooms must be secured by this date in order to receive the PDA rate).

Conference Registration Hours

Sunday, April 14: 2:00 p.m. – 6:00 p.m.

Monday, April 15: 7:00 a.m. – 5:00 p.m.

Tuesday, April 16: 7:00 a.m. – 5:00 p.m.

Wednesday, April 17: 7:00 a.m. – 1:00 p.m.

Post-Conference Workshop Registration Hours

Wednesday, April 17: 7:30 a.m. – 5:30 p.m.

Thursday, April 18: 7:00 a.m. – 4:00 p.m.

TRI Course Registration Hours

Thursday, April 18: 7:30 a.m. – 4:00 p.m.

Friday, April 19: 7:30 a.m. – 4:00 p.m.

Dress/Attire

Business casual attire is recommended for the 2013 PDA Annual Meeting. Since the temperature in meeting rooms tends to be cool, please bring a jacket or sweater for your comfort.

Special Requirements

If you require special accommodations to fully participate, please attach a written description of your

needs with your registration form. Specific questions can be directed to [email protected].

Contact Information

Conference/Workshop inquiries: Wanda Neal, CMP, Senior Vice President, Programs and Registration Services Phone: +1 (301) 656-5900 ext. 111 E-mail: [email protected]

Melissa Pazornik, Speaker & Logistics Coordinator Phone: +1 (301) 656-5900 ext. 221

Registration inquiries: Megan Kuhman, Registration and Customer Service Phone: +1 (301) 656-5900 ext. 115 E-mail: [email protected]

PDA TRI course inquiries: Stephanie Ko, Senior Manager, Lecture Education Phone: +1 (301) 656-5900 ext. 151 E-mail: [email protected]

Exhibition/Sponsorship inquiries: David Hall, Vice President, Sales Phone: +1 (301) 760-7373 Cell: +1 (240) 688-4405 Fax: +1 (301) 986-0296 E-mail: [email protected]

General Information

April 15-17, 2013 | The Peabody Orlando | Orlando, Florida

2013 PDA Annual Meeting and Networking EventsFAX: +1 (301) 986-1093 (USA) MAIL: PDA Global Headquarters, 4350 East West Highway, Suite 150, Bethesda, MD 20814 USA

1 Contact Information PDA Membership Number:

Name (Last, First, MI)

Job Title

Department Company

Mailing Address

City State/Province ZIP+4/Postal Code

Country Email

Business Phone Fax

Substituting for

(Check only if you are substituting for a previously enrolled colleague; the fee difference in the prevailing rate is due at the time of substitution. Please note that if you are a non-member substituting for a member, you will be required to pay the difference in the non-member fee.)

2 Conference Registration | April 15-17, 2013 Please check appropriate fee (US$).

Member Nonmember Government/Health Authority Academic StudentMember Nonmember* Member Nonmember* Member Nonmember*

Before February 1, 2013 $ 1,595 $ 1,844 $ 700 $ 800 $ 695 $ 795 $ 225 $ 285

February 1 – March 1, 2013 $ 1,795 $ 2,044 $ 700 $ 800 $ 775 $ 875 $ 280 $ 310

After March 1, 2013 $ 1,995 $ 2,244 $ 700 $ 800 $ 860 $ 960 $ 380 $ 410

3 Workshop Registration | April 17-18, 2013 Please check appropriate fee (US$).

2013 PDA Human Factors Workshop | Workshop Only $ 700

2013 PDA Human Factors Workshop | Workshop in Addition to Full Conference Purchase

$600

4 Networking Registration: Please check appropriate fee (US$).

Sunday, April 14, 2013 | 7th Annual PDA Golf Tournament at the Shingle Creek Golf Course # of tickets: ____ $ 155

Sunday, April 14, 2013 | 7th Annual Walk/Run # of tickets: ____ $ 30

Tuesday, April 16, 2013 | Orlando Dine Around # of tickets: ____ No Price Decided

Total Due $

5 Payment Options All cards are charged in US$.

By Credit Card – Clearly indicate account number and expiration date and billing address. Please bill my: American Express MasterCard VISATotal amount $ Credit Card Guarantee Only Account Number Exp. Date

Name (exactly as it appears on card) Signature

Billing address

City State Zip

Country

Wire Transfer Payments: If you require wire transfer, please contact Patresa Day at [email protected]

CONFIRMATION: A letter of confirmation will be sent to you once payment is received. You must have this written confirmation to be considered enrolled in a PDA event. Please allow one week for receipt of confirmation letter. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. Please be advised that if your payment or written cancellation notice is not received by February 15, 2013 your credit card will be charged the prevailing rate. SUBSTITUTIONS: If you are unable to attend, substitutions can be made at any time, including on-site at the prevailing rate. If you are pre-registered as a substitute attendee, indicate this on the registration form.The fee difference in the prevailing rate is due at the time of substitution. Please note that if you are a non-member substituting for a member, you will be required to pay the difference in the non-member fee. REFUNDS: Refund requests must be in writing and faxed to +1 (301) 986-1093. (Emails and phone messages are not accepted). Refunds for Conference/Event: If your written request is received on or before February 15, 2013, you will receive a full refund minus a $200 processing fee. After that time, no refunds or credit requests will be approved. On-site registrants are not guaranteed to receive conference materials until all advanced registered attendees receive them. PDA reserves the right to modify the material or speakers/instructors without notice, or to cancel an event. If an event must be cancelled, registrants will be notified by PDA in writing as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA at [email protected] or +1 (301) 656-5900. PHOTO RELEASE: By registering for the 2013 PDA Annual Meeting, I authorize PDA the right to photograph me and to use the photographs in all formats and media for any purpose, including for education, marketing and trade purposes. I hereby release PDA from all claims arising out of the use of the photographs, including without limitation all claims for compensation, libel, invasion of privacy or violation of copyright ownership.

PDA USE ONLY Date: Check: Amount: Account:

* For this membership type, on-line registration is not available and must be faxed in. Please note: In order to receive the prevailing rate, your registration(s) with payment must be received by PDA by 5:00 p.m. ET on or before the date noted.

Special Dietary Requirements (Please be specific):

PDA Federal Tax I.D. #52-1906152

Group Registration: Register 4 people from the same organization as a group (at the same time) for the conference and receive the 5th registration free. Other discounts cannot be applied. All forms MUST be faxed in together.

Register by February 2nd and receive access to prior conference recordings for 60 days.

2013 PDA Annual Meeting Course SeriesApril 18-19, 2013 | The Peabody Orlando | Orlando, Florida Conference: April 15-17 | Exhibition: April 15-16 2013 PDA Human Factors Workshop: April 17-18

Registration for the 2013 PDA Annual Meeting is fast and simple... CLICK, FAX OR MAIL:CLICK: www.pda.org/annual2013 | FAX: +1 (301) 986-1093 (USA) MAIL: PDA Global Headquarters, 4350 East West Highway, Suite 150, Bethesda, MD 20814 USA

1 Contact Information PDA Membership Number:

Name (Last, First, MI)

Job Title

Department Company

Mailing Address

City State/Province ZIP+4/Postal Code

Country Email

Business Phone Fax

Substituting for

(Check only if you are substituting for a previously enrolled colleague; the fee difference in the prevailing rate is due at the time of substitution. Please note that if you are a non-member substituting for a member, you will be required to pay the difference in the non-member fee.)

Price On or Before March 1, 2013 Price After March 1, 2013

2 Course Registration | April 18-19, 2013Please check appropriate fee (US$). Standard

Government/Health Authority/Academic Standard

Government/Health Authority/Academic

Member Nonmember Member Nonmember* Member Nonmember Member Nonmember*#216 Recommended Practices for Manual Aseptic Processes (April 18) $ 895 $ 1,165 $ 600 $ 700 $ 995 $ 1,295 $ 600 $ 700

#476 Biofilms (April 18) $ 895 $ 1,165 $ 600 $ 700 $ 995 $ 1,295 $ 600 $ 700#107 Single Use Systems (April 18) $ 895 $ 1,165 $ 600 $ 700 $ 995 $ 1,295 $ 600 $ 700#313 Steam in Place (April 18) $ 895 $ 1,165 $ 600 $ 700 $ 995 $ 1,295 $ 600 $ 700#374 Process Simulation Testing for Aseptically Filled Products (April 19) $ 895 $ 1,165 $ 600 $ 700 $ 995 $ 1,295 $ 600 $ 700

#442 Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Validation and Ongoing Control (April 19) $ 895 $ 1,165 $ 600 $ 700 $ 995 $ 1,295 $ 600 $ 700

3 Conference Registration | April 15-17, 2013 Please check appropriate fee (US$).

Member Nonmember Government/Health Authority Academic StudentMember Nonmember* Member Nonmember* Member Nonmember*

Before February 1, 2013 $ 1,595 $ 1,844 $ 700 $ 800 $ 695 $ 795 $ 225 $ 285

February 1 – March 1, 2013 $ 1,795 $ 2,044 $ 700 $ 800 $ 775 $ 875 $ 280 $ 310

After March 1, 2013 $ 1,995 $ 2,244 $ 700 $ 800 $ 860 $ 960 $ 380 $ 410

* For this membership type, on-line registration is not available and must be faxed in. Please note: In order to receive the prevailing rate, your registration(s) with payment must be received by PDA by 5:00 p.m. ET on or before the date noted.

4 Payment Options All cards are charged in US$.

By Credit Card – Clearly indicate account number and expiration date and billing address. Please bill my: American Express MasterCard VISATotal amount $ Credit Card Guarantee Only Account Number Exp. Date

Name (exactly as it appears on card) Signature

Billing address

City State Zip

Country

Wire Transfer Payments: If you require wire transfer, please contact Patresa Day at [email protected]

CONFIRMATION: A letter of confirmation will be sent to you once payment is received. You must have this written confirmation to be considered enrolled in a PDA event. Please allow one week for receipt of confirmation letter. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. Please submit payment for the prevailing rate. SUBSTITUTIONS: If you are unable to attend, substitutions can be made at any time, including on-site at the prevailing rate. If you are pre-registered as a substitute attendee, indicate this on the registration form.The fee difference in the prevailing rate is due at the time of substitution. Please note that if you are a non-member substituting for a member, you will be required to pay the difference in the non-member fee. REFUNDS: Refund requests must be in writing and faxed to +1 (301) 986-1093. (Emails and phone messages are not accepted). If you are an unpaid registrant and do not attend the event, you are responsible for paying the registration fee at the on-site registration rate if your cancellation has not been received in writing on or before March 19, 2013. On-site registrants are not guaranteed to receive conference materials until all advanced registered attendees receive them. Refunds for Conference/Event: If your written request is received on or before February 15, 2013, you will receive a full refund minus a $200 processing fee. After that time, no refunds or credit requests will be approved. On-site registrants are not guaranteed to receive conference materials until all advanced registered attendees receive them. PDA reserves the right to modify the material or speakers/instructors without notice, or to cancel an event. If an event must be cancelled, registrants will be notified by PDA in writing as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA at [email protected] or +1 (301) 656-5900. REFUND FOR COURSES: If your written request is received by March 19, 2013, you will receive a full refund less a $200 processing fee. After that time, no refunds or credit approvals will be made. COURSE CANCELLATION: PDA reserves the right to modify the material or speakers/instructors without notice, or to cancel an event. If an event must be cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. PHOTO RELEASE: By registering for the 2013 PDA Annual Meeting, I authorize PDA the right to photograph me and to use the photographs in all formats and media for any purpose, including for education, marketing and trade purposes. I hereby release PDA from all claims arising out of the use of the photographs, including without limitation all claims for compensation, libel, invasion of privacy or violation of copyright ownership.

PDA USE ONLY Date: Check: Amount: Account:

PDA Federal Tax I.D. #52-1906152

Attendees receive a $200 discount when they register for both the conference and a course. This offer is not valid for government/health authority, academic or student registrations. Other discounts cannot be applied.

Register for the conference before February 2nd and receive access to prior conference recordings for 60 days.

Modern Sterile Product Manufacture –Exploring Best Practices andSeeking New ApproachesApril 15-17, 2013 The Peabody Orlando | Orlando, Florida

Exhibition and Sponsorship OpportunitiesThe 2013 PDA Annual Meeting will provide your company the premier opportunity to gain access to and network with key decision makers from the biopharmaceutical science and manufacturing industry. Make new contacts, discuss ongoing projects, discover new opportunities, and reconnect with current customers by exhibiting at and/or sponsoring the industry’s leading conference and exhibition. Extended, dedicated exhibit hall hours will allow ample time for information exchange with attendees and industry subject matter experts from companies such as Genentech, Eli Lilly, Pfizer, Amgen, GlaxoSmithKline, Abbott, Roche, Novartis, Merck and others. In addition, many high profile, cost-effective sponsorship options are available to help your company increase exposure, build brand awareness, and stand out from the crowd.

The 2013 PDA Human Factors and Human Error Reduction Workshop will also include focused exhibition and sponsorship opportunities for a very limited number of companies. Discounted packages are available for 2013 PDA Annual Meeting exhibitors and sponsors.

For more information about exhibit and sponsorship opportunities, please contact:

David Hall, Vice President, SalesDirect: +1 (301) 760-7373 | Cell: +1 (240) 688-4405 | E-mail: [email protected]

PDA Global Headquarters4350 East West HighwaySuite 150Bethesda, MD 20814 USAPhone: +1 (301) 656-5900Fax: +1 (301) 986-0296

2013 PDA Annual Meeting Brochure

www.pdaannualmeeting.org

Register before February 1, 2013

and save up to $400!

“The subject matter experts assembled from the

global pharmaceutical industry were full of valuable insights and recommendations. I walked away

with an immense amount of practical solutions to

many issues.” EJ Brandreth,

Althea Technologies.

Preliminary Agenda Inside

Modern Sterile Product Manufacture â€“ Exploring Best Practices

Documents

Transcript of Modern Sterile Product Manufacture â€“ Exploring Best Practices