PDA 8th Microbiology Conference

www.pda.org/microbiology2013Exhibition: October 21-22 | Course: October 24-25

This preliminary agenda is current as of June 18, 2013

The Parenteral Drug Association presents...

PDA 8th Annual Global Conference

on Pharmaceutical Microbiology

October 21-23, 2013 Bethesda North Marriott Hotel

Bethesda, Maryland

Register before August 9 and save up to $400

Special Session Ask the Regulators:

Dennis Guilfoyle, PhD, ORA, FDA

Patricia Hughes, CDER, FDADavid Husson, PhD,

CDER, FDA

Enter Campaign Code MicroBrochure on your registration form.

www.pda.org/microbiology20132

Connecting People, Science and Regulation®

Program Planning Committee

A Message from the Program Co-Chairs

Program Co-Chairs

Marla Stevens - Riley, PhD CDER, FDA

Osama (Sam) Elrashidy Bayer Healthcare Pharmaceuticals, Inc.

Program Committee

Edward S. Balkovic, PhD Genzyme – A Sanofi Company

Julie Barlasov Perritt Laboratories, Inc

Jason E. Brown PDA

Marsha Hardiman Medtronic, Inc.

Chris Knutsen, PhD Bristol-Myers Squibb

Richard Levy, PhD PDA

Michael J. Miller, PhD Microbiology Consultants, LLC

Amy McDaniel, PhD Pfizer

John Metcalfe, PhD CDER, FDA

Cheryl Platco Merck Research Laboratories

Kalavati Suvarna, PhD CDER, FDA

Edward Tidswell, PhD Baxter Healthcare Corporation

Kim Van Antwerpen PetNet Solutions, A Siemens Company

USP Liaison

Radhakrishna Tirumalai, PhD USP

Exhibit Committee Liaison

Karen Mullen BioPharma

Dear Colleagues:

On behalf of the program planning committee, we would like to invite you to attend the PDA 8th Annual Global Conference on Pharmaceutical Microbiology to be held on October 21-23, 2013 in Bethesda, Maryland. This year our conference theme is Staying Ahead of the Curve: Proactive Pharmaceutical Microbiology and this year’s conference offers a selection of new scientific information and recent global regulations that ensure that we as pharmaceutical microbiologists stay ahead of the curve. This conference maintains its reputation for offering invaluable sessions dedicated to pharmaceutical microbiology and for providing venue to network with fellow microbiologists, experts in all areas of pharmaceutical microbiology, key vendors of microbiology testing equipment & supplies, and regulatory/compliance professionals.

The conference will commence with the keynote address, “Explorations of the Human Microbiome” given by Karen E. Nelson, PhD, President of the J. Craig Venter Institute. This presentation will provide an overview of recent findings of the Human Microbiome Project. Then the conference moves to concurrent sessions on “Environmental Monitoring” and “Lean Labs” with both sessions focusing on adapting to change. The afternoon’s concurrent sessions offer something old and something new. The “Endotoxins” session returns, and we introduce a new session “Non-sterile Drug Products.” Finally we close the day with a recurring favorite “Urban Myths” to help us confront those manufacturing “tall-tales” that we are convinced are true.

Ian Critchley, PhD, Vice-President of Clinical Microbiology of Cerexa, Inc., is our keynote speaker for the second day. He will offer an industry perspective on anti-microbial resistance and his experience with the FDA in getting new therapies to market quickly. Day 2 is also filled with mix of old and new sessions. An “Advanced Methods” session returns in response to the pharmaceutical industry’s increasing implementation of advanced technologies and rapid methods, and the “Workforce Development” session continues to address the critical need for well-trained pharmaceutical microbiologists. Two new sessions “Quality Risk Assessments” and “Globalization Challenges” address considerations needed when establishing microbial control and testing at facilities within the United States or abroad. Finally, the day ends with the popular “Emerging Leaders” session that provides an opportunity for early career scientists to share microbiological case studies.

The final conference day focuses on pharmaceutical microbiology standards and regulation. The “USP updates” session will provide an overview of the proposed changes to USP general chapters related to Microbiology, and the remainder of the conference will be devoted to regulatory issues. A FDA regulator will present updates on domestic and global inspection issues, followed by conference attendees posing their pharmaceutical microbiology questions directly to FDA personnel with expertise in field and center issues in the “Ask the Regulators” panel discussion.

For a more interactive experience and a greater opportunity to learn about other pharmaceutical microbiology topics and technologies, poster presentations and vendor exhibits are available during the first two days of the conference. In addition, we have scheduled meetings for the PDA Biotechnology and the Environmental Monitoring Interest Groups.

Lunches and refreshment breaks will provide a relaxed environment to discuss the issues raised during the day’s presentations, and the networking reception on Monday evening will allow time for visiting with vendors and fellow attendees.

For continuing education and training, PDA’s Training and Research Institute (PDA TRI) will offer several courses relevant to pharmaceutical microbiology and manufacturing immediately following the conference.

Please join us October 21-23 in Bethesda, Maryland for this unique and interactive learning opportunity!

Sincerely,

Marla Stevens-Riley, PhD Team Leader/Senior Review Microbiologist, Office of Generic Drugs, CDER, FDA and Program Planning Committee Co-chair

Osama Elrashidy, Associate Director Bayer Healthcare and Program Planning Committee Co-chair

www.pda.org/microbiology2013 3

PDA 8th Annual Global Conference on Pharmaceutical MicrobiologyOctober 21-23, 2013 | Bethesda North Marriott Hotel | Bethesda, Maryland

Exhibition: October 21-22 | Course: October 24-25

Sunday, October 20 – Monday, October 21, 2013 AgendaSunday, October 20, 20134:00 p.m. - 6:00 p.m. Registration Open

Monday, October 21, 20137:00 a.m. - 5:15 p.m.Registration Open

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

8:00 a.m. - 8:15 a.m. Welcome and Opening Remarks from Program Planning Committee Co-chair Marla Stevens-Riley, PhD, Team Leader/Senior Microbiology Reviewer, CDER, FDA

8:15 a.m. - 9:15 a.m. P1: Opening Keynote AddressModerator: Marla Stevens-Riley, PhD, Team Leader/Senior Microbiology Reviewer, CDER, FDA

The Human Microbiome Project is a National Institutes of Health interdisciplinary initiative with the goal of identifying and characterizing the microorganisms that are found in association with both healthy and diseased humans. Since 2008, a network of scientists and laboratories has been investigating how changes in the human microbiome are associated with human health or disease, and in 2012 the initial findings were published. Research is demonstrating that our normal flora play a key role in disease function and body chemistry, and help to determine who we are as human beings. This presentation will provide an overview of this initiative and some selected findings.

8:15 a.m. - 9:00 a.m.Explorations of the Human MicrobiomeKaren E. Nelson, PhD, President, J. Craig Venter Institute (JCVI)

9:00 a.m. - 9:15 a.m.Q&A/Discussion

9:00 a.m. - 6:30 p.m. Exhibit Hall Open

9:15 a.m. - 10:00 a.m. Refreshment Break and Poster Presentations in Exhibit Hall

Poster PresentationsThe following posters will be presented during refreshment

breaks and the networking reception

BacT/ALERT® 3D Systems Vented iFN Plus Anaerobic Medium used as an Alternative Aerobic Medium for Neutralization of Thimerosal Mary Beth Anheuser, Staff Scientist, bioMerieux, Inc.

Depyrogenation and Sterilization of Medical Device Materials with Nitrogen Dioxide Gas James Cooper, PhD, Consultant/Founder, Charles River ENDOSAFE, Inc.

The Effect of Cell Shape on Microorganism Membrane Retention under Different Filtration Processing Conditions Danielle DeCesaro, Research Scientist I, EMD Millipore

Feasibility Study: Microbial Evaluation of a Chemically-Defined Media-Fill Test (MFT) Medium Barbara Gerten, Research & Development Manager, Merck KGaA, Merck/Millipore Biomonitoring

Validation of a Real-Time Growth-based Rapid Microbial Method for the Sterility Testing Associated with an Autologous Chondrocyte Transplantation Therapy Sherri Hopple, Senior Quality Control Associate, Aesculap Biologics

The Effect of Temperature and Volume on Microorganism Retention under Different Filtration Processing Conditions Lia Jeffrey, Microbiological Scientist III, EMD Millipore

Designing and Implementing Bioburden Sample Hold Time Studies: How to Streamline Testing by Understanding Your Process and Sample Matrices Lynn Johnson, Scientist II, Pfizer, Inc.

Validation of and Corporate Value from the Automation of Environmental Monitoring, Water and Bioburden Test Methods David Jones, PhD, Director of Technical Services, Rapid Micro Biosystems

Gamma Sterilization of Pharmaceuticals - An Irradiation Review of Excipients, Active Pharmaceutical Ingredients and Final Drug Product Formulations Wayne Mullett, Director, Development, Nordion Inc.

An Assessment for Implementation of the MALDI-TOF Biotyper Jennifer Reyes, Principal Analyst, Genzyme

Performance Evaluation of 0.1 µm-Rated Filters When Challenged with Mycoplasma Orale Christine Wright, PhD, Research Scientist, EMD Millipore



Monday, October 21, 2013 Agenda (continued)

12:00 p.m. - 1:00 p.m. Exhibitor Roundtable Luncheon - Exhibitors will be seated at designated tables and will be available for informal discussion with attendees

Choose from 2 Concurrent Sessions

1:00 p.m. - 3:00 p.m. A2: Microbiological Quality of Non-Sterile ManufacturersModerator: Julie Barlasov, Laboratory Manager, Perritt Laboratories, Inc

This session will provide an overview of the manufactureof non-sterile products. Both regulatory and industryperspectives will be examined. The session is structured to allow sufficient time for audience questions and discussions during the question and answer portion immediately following the podium presentations.

1:00 p.m. - 1:30 p.m.Regulatory Reviewer Perspectives for Non-Sterile Drug Products John Metcalfe, PhD, Senior Review Microbiologist, CDER, FDA

1:30 p.m. - 2:00 p.m.Risk Management Assessment for Non-Sterile Manufactures Scott Sutton, PhD, Principal, Microbiology Network, Inc.

2:00 p.m. - 2:30 p.m.Industry Perspectives for Non-Sterile Drug Products Anthony Cundell, PhD, Director, Pharmaceutical Sciences, Microbiology, Merck & Co. (Invited)

2:30 p.m. - 3:00 p.m.Q&A/Discussion

1:00 p.m. - 3:00 p.m. B2: Recent issues with Endotoxin Testing, Specification Setting, and Regulatory Expectations in response to the new FDA “Guidance for Industry: Pyrogen and Endotoxins Testing: Questions and Answers”Moderator: Cheryl Platco, Principal Scientist, Merck Research Laboratories

The FDA published a new document in June 2012 “Guidance for Industry: Pyrogens and Endotoxin Testing Questions and Answers.” The goal of this session is to clarify new expectations, provide information on new specification setting calculations, and clarify concerns about demonstrating endotoxin stability including the design of appropriate procedures when testing complex samples for endotoxin levels.

1:00 p.m. - 1:30 p.m.Recent Issues with Endotoxin Testing and Specification Setting in Response to FDA Q & AKaren Zinc McCullough, MMI Associates and member of USP Expert Committee for Microbiological Chapters

1:30 p.m. - 2:00 p.m.An Approach for Successful Endotoxin Challenge Study Design to Mitigate Low Endotoxin Recovery ConcernsJay Bolden, Consultant Biologist, Global Quality Laboratories, Eli Lilly & Company

2:00 p.m. - 2:30 p.m.Myths and Truths About Endotoxin RecoveryJames Cooper, PhD, Consultant, Founder, Endotoxin Consulting



10:00 a.m. - 12:00 p.m. A1: Using Environmental Monitoring Data to Understand the Industrial MicrobiomeModerator: Kim Van Antwerpen, Regional Quality Compliance Specialist, PetNet Solutions

Staying ahead of the curve in regard to Environmental Monitoring requires an understanding and an anticipation of the constantly changing microbial climate of the pharmaceutical manufacturing process. Knowing the characteristics of the environments in that process provides the benefit of allowing us to predict and solve potential future microbial control issues. This session will discuss pathways to use the data obtained from environmental monitoring to provide proactive and practical solutions for comprehending and managing everyday pharmaceutical microbiology challenges.

10:00 a.m. - 10:30 a.m.HMP and Implications for Environmental MonitoringTim Sandle, PhD, Head of Microbiology, Bio Products Laboratory (Invited)

10:30 a.m. - 11:00 a.m.Industry Perspectives on Environmental Monitoring Part II Jeanne Moldenhauer, Vice President, Excellent Pharma Consulting (Invited)

11:00 a.m. - 11:30 a.m.Industry Perspectives on Environmental Monitoring Part IIIIndustry Presenter to be announced

11:30 a.m. - 12:00 p.m.Q&A/Discussion

10:00 a.m.-12:00 p.m. B1: Lean Laboratory Concepts and Continuous Improvement in the Microbiology LaboratoryModerator: Amy McDaniel, PhD, Director, QC Microbiology, Pfizer, Inc.

The time sensitive nature of samples and the lengthy incubation periods for microbial testing provide unique challenges for the application of lean laboratory concepts to the Microbiology Laboratory. However, with the use of relevant lean concepts and tools, the transformation of the microbiology laboratory can achieve and sustain substantial efficiency gains. This session will provide examples of implementation of lean concepts and continuous improvement in the QC microbiology laboratory.

10:00 a.m. - 10:30 a.m.Sustaining a Lean Microbiology LaboratoryHemangini Patel, Associate Director, QC Microbiology, Pfizer Biotech

10:30 a.m. - 11:00 a.m.Continuous Improvement Examples in the Microbiology LaboratoryGordon Walker, Senior Manager, Microbiology Group, Genentech, Inc.

11:00 a.m. - 11:30 a.m.Lean Laboratory Operations and Organization in Support of a Single Use Manufacturing FacilityIndustry Presenter to be announced

11:30 a.m. - 12:00 p.m.Q&A/Discussion




Monday, October 21 – Tuesday, October 22, 2013 Agenda

8:35 a.m. - 9:30 a.m. P3: Day 2 Keynote AddressModerator: Osama Elrashidy, Associate Director, Quality Control, Bayer Healthcare Pharmaceuticals, Inc.

Antimicrobial resistance has been a major concern all over the world. What are the reasons behind this resistance, and how can we deal with many resistant microorganisms that cause severe harm to the human race? Our speaker, Dr. Ian Critchley, will give a brief summary on the history of Antimicrobial resistance, the challenges that face any company working in this area and how the pharmaceutical companies identify the need for new agents and develop them. Dr. Critchley will also talk about the challenges that face these companies to get these new products approved and available for the patients.

8:35 a.m. - 9:15 a.m.Antimicrobial Resistance – History, Challenges, New Discoveries and Approvals Ian Critchley, PhD, Vice President, Clinical Microbiology, Cerexa, Inc.


9:15 a.m. - 4:00 p.m. Exhibit Hall Open

9:30 a.m. - 10:15 a.m. Refreshment Break, Poster Presentations, and Passport Raffle Prize Drawing in Exhibit Hall


10:15 a.m. - 12:15 p.m. Session A3: Advanced Methods/TR 33Moderator: Michael J. Miller, PhD, President, Microbiology Consultants, LLC

The momentum within the pharmaceutical industry to implement advanced and rapid microbiological methods continues to increase, and this session will explore recent enablers, technologies and case studies that are making the switch from traditional methods a reality. The long-awaited revision to PDA Technical Report #33 will be discussed in detail, covering regulatory expectations, validation guidance, technologies and implementation strategies. Next, a novel endotoxin platform that utilizes an ELISA-based assay will be presented, which will focus on phage-protein based solid phases to detect endotoxin-contaminated surfaces. Finally, an actual case-study on how one pharmaceutical end-user has successfully implemented a rapid method for routine monitoring in a manufacturing environment will be presented.

10:15 a.m. - 10:45 a.m.Implementation of the MALDI-TOF Biotyper for Microbial Identifications in a QC Microbiology LaboratoryEbony Arrington, Scientist, QC Microbiology, Pfizer, Inc.

10:45 a.m. - 11:15 a.m. An Advanced Phage Protein-based Endotoxin Assay: Insights and Strategies for Overcoming Low Endotoxin Recovery in Complex FormulationsJohannes Reich, PhD Student, Hyglos GmbH

3:00 p.m. - 3:45 p.m. Refreshment Break and Poster Presentations in Exhibit Hall

3:45 p.m. - 5:15 p.m. P2: Urban MythsModerator: Rich L. Levy, PhD, Senior Vice President, Science and Regulatory Affairs, PDA

There has been an increased emphasis on “science-based regulation”, which begs the question of how much of our common microbiological wisdom in the pharmaceutical industry is actually based on fact. This session will look at important aspects of pharmaceutical microbiology from this perspective. The presenters will explore our current understanding and “best practice” with an eye to determining whether what we believe is reality is in fact rooted in “good science”.

3:45 p.m. - 4:15 p.m.Urban Myths of Sterility Testing Ken Paddock, Research Manager, TR Sterility Assurance, Baxter Healthcare Corporation

4:15 p.m. - 4:45 p.m.Urban Myths of Single Use Systems Robert Repetto, Senior Director, Pfizer, Inc.


5:15 p.m. - 6:30 p.m. Networking Reception

Tuesday, October 22, 20137:30 a.m. - 5:30 p.m. Registration Open

7:30 a.m. - 8:30 a.m. Continental Breakfast

7:30 a.m. - 8:30 a.m.Breakfast: Biotechnology Interest Group Leader: Vince Anicetti, Executive Director of Quality, Boehringer Ingelheim Fremont, Inc.

The biotech interest group will provide an update on the bioburden and biofilm management technical report. The interest group will also present findings of the PDA bioburden and biofilm management practices survey.



Tuesday, October 22, 2013 Agenda (continued)


1:15 p.m. - 3:15 p.m. A4: Globalization Challenges Moderator: Kalavati Suvarna, PhD, Microbiologist, CDER, FDA

The landscape for pharmaceutical product manufacture has changed with globalization. As a means to reduce costs, companies continue to move manufacturing activities to new locations. The challenges in continuing to ensure safety and quality of products manufactured in various parts of the world are many and complex. This session will highlight the challenges faced during selection of a contract manufacturing organization, quality agreement negotiations, and transfer of production process and analytical methods using case studies.

1:15 p.m. - 1:45 p.m.Microbiology Associated Challenges with Cell Therapy Products and Monoclonal Antibodies Anthony Lubinecki, Vice President, Upstream Drug Substance & Technology Management, Centocor R&D

1:45 p.m. - 2:15 p.m.Methods Transfer from US to International TerritoryAthena Nagi, Principal Scientist, Process Development and Analytical Sciences, Amgen, Inc. (Invited)

2:15 p.m. - 2:45 p.m. Regulatory Requirements for Environmental Monitoring and how to Prepare Global Procedures Jette Christensen, Aseptic Scientific Director, Novo Nordisk A/S


1:15 p.m. - 3:15 p.m. B4: Workforce DevelopmentModerator: Edward Tidswell, PhD, Director, Sterility Assurance, Baxter Healthcare Corporation

As more of the “Baby-Boom” generation reaches retirement age, there is a need to accelerate our development of future Pharmaceutical Microbiologists. Speakers in this session have been selected to discuss: how students are being currently being prepared (i.e. availability of academic training), what skillsets these future QC Micro folks will need, and how we are actually handle training (OJT) of new QC Micro employees using case studies.

1:15 p.m. - 1:45 p.m.Mentoring: Assisting QC Analysts in becoming MicrobiologistsEdward S. Balkovic, PhD, Principal Microbiologist, Genzyme – A Sanofi Company

1:45 p.m. - 2:15 p.m.Microbiology PODS Creating a Fast and Flexible Workforce Rebecca Clark, Quality Control Microbiology Laboratory Manager, Pfizer, Inc.

2:15 p.m. - 2:45 p.m.Workforce Development: BiasMichael Long, PhD, Director and Principal Consultant, Concordia ValSource


Session A3: Advanced Methods/TR 33 (continued)

11:15 a.m. - 11:45 a.m. Revision of Technical Report 33Michael J. Miller, PhD, President, Microbiology Consultants, LLC

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

10:15 a.m. - 12:15 p.m. Session B3: Quality Risk AssessmentsModerator: Chris Knutsen, PhD, Associate Director, Microbiology, Bristol-Myers Squibb

Quality Risk Assessment. What is it and why? The nature of microbial testing and control is changing as the global expectations are being harmonized. For example, in the early 2000’s the International Harmonization Committee issued ICH9, Quality Risk Assessment and in 2006, the FDA issued “A Guidance for Industry Q9, Quality Risk Assessment. These documents have been included into the Eudralex Good Manufacturing Practice Guidelines. We are hearing reports that facilities are now getting cited for not having programs actively in place even if they are currently in progress. While this is not especially news, many companies are just beginning to look at ways to implement these types of programs. There is no one way to implement a program such as this. Any implementation must take into account the process that is being evaluated, the variables involved in these processes and also the corporate culture that may be in place at the facility. In this section, real-world experiences in the approach to implementing this type of program will be discussed, at least in a very defined portion of the overall microbiology program in pharmaceutical manufacturing.

10:15 a.m. - 10:45 a.m.Profound Root Cause Analysis and Continuous Improvement to Control Bioburden on a Particular Process Step during Manufacturing of Biologic ProductsLada Laenen, PhD, Head Technology Department, Cell Culture and microbiology, Genzyme – A Sanofi Company

10:45 a.m. - 11:15 a.m.Assessing Microbial Risk from Development to Manufacturing Linda Skowronsky, Senior Development Microbiologist, Glaxo Smith-Kline

11:15 a.m. - 11:45 a.m.Industry Perspectives on Quality Risk Assessment Industry Presenter to be announced

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

12:15 p.m. - 1:15 p.m. Lunch




Tuesday, October 22 – Wednesday, October 23, 2013 AgendaWednesday, October 23, 20137:00 a.m. - 12:50 p.m. Registration Open

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

8:00 a.m. - 9:15 a.m.P5: USP Updates Moderator: Radhakrishna Tirumalai, PhD, Principal Scientific Liaison-General Chapters, US Pharmacopeial Convention

Compatible with its overall mission, the role of USP in Microbiology is to develop public standards pertaining to microbiology that, along with other requirements, ensure the consistent quality of products. This session will provide an overview on current activities of the USP General Chapters-Microbiology Expert Committee, with emphasis on recent revisions and new chapter proposals.

8:00 a.m. - 8:30 a.m.USP Updates Part IIndustry Presenter to be announced

8:30 a.m. - 9:00 a.m.USP Updates Part IIIndustry Presenter to be announced


9:30 a.m. - 10:30 a.m. P6: Day 3 Keynote Address – Regulatory Updates Moderator: Paul L. Dexter, Microbiology Team Leader, CDER, FDA

This presentation will discuss global inspection issues and CGMPs for pharmaceutical manufacturing and microbiology. An FDA representative will describe current issues and polices relevant to US manufacturing facilities’ and abroad.

9:30 a.m. - 10:15 a.m.Global Inspection Issues and cGMPsMonica Caphart, Branch Chief, Division of Medical Products and Tobacco Operations, ORA, FDA


10:30 a.m. - 11:00 a.m. Refreshment Break

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

4:00 p.m. - 5:30 p.m. P4: Emerging LeadersModerator: Osama Elrashidy, Associate Director, Quality Control, Bayer Healthcare Pharmaceuticals, Inc.

For the third year in a row, and after two very successful years, this session is back due to overwhelming acceptance from the conference attendees. This session will focus on future leaders and their role in the advancement of Pharmaceutical microbiology. It gives a great opportunity for new faces to interact with the audience by presenting a brief interesting scientific presentation about issues related to Pharmaceutical microbiology and allows open interaction between all attendees and the emerging leaders to discuss and exchange ideas and thoughts. It is a great session to encourage new faces to become visible and exposed to the PDA community.

4:00 p.m. - 4:15 p.m.“Bugged Out” Be Prepared with a Microbiologist’s Contamination Survival KitHilary Chan, Quality Scientist, Pfizer, Inc.

4:15 p.m. - 4:30 p.m. Zero to New Lab in 60 Seconds Christopher Day, Senior Research Investigator, Bristol-Myers Squibb Company

4:30 p.m. - 4:45 p.m. Advanced Microbiological Systems? Show me the Savings Heather Greiner, QC Senior Associate Scientist, Pfizer, Inc.


5:35 p.m. - 6:35 p.m.Microbiology/Environmental Monitoring Interest Group SessionLeader: Jeanne Moldenhauer, Vice President, Excellent Pharma Consulting

This meeting of the Microbiology/EM IG will focus on issues with endotoxin testing. Dr. Joseph Chen will be discussing issues in endotoxin recovery methods for common biological products. Other issues with recovery/validation will also be discussed.

Panelist:Joseph C. Chen, PhD, Senior Principal Scientist, Biologics Quality, Genentech Inc.



Wednesday, October 23, 2013 Agenda (continued)

Continuing EducationThe PDA Training and Research Institute is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so,

participants must sign in at the beginning of the program, submit the provided evaluation forms and submit the CPE credit request form to the registration desk following full attendance of this event. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

PDA 8th Annual Global Conference on Pharmaceutical MicrobiologyACPE #0116-0000-13-083-L04-P | 1.6 CEUsType of Activity: Knowledge

Learning Objectives: At the completion of this conference, participants will be able to:

• Describe the current and future role of microbiology in managing microbial risk, microbial contamination control and risk management in aseptic and sterile manufacturing

• Discuss current and anticipated requirements in maintaining microbiological (bioburden and pyroburden) control of product components prior to sterilization and in maintaining sterility of products

• Implement appropriate strategies for maintaining a sterile manufacturing environment (the importance of microbial identification, testing for and understanding the impact of objectionable organisms and resolving microbial challenges associated with sterile operations)

• Summarize advances in new technologies and rapid microbiological methods, microbial identification technologies, and endotoxin testing for quality control and process control during manufacturing

• Identify local regulatory and pharmacopeial expectations

Who Should Attend:Departments: Microbiology, Compliance, Engineering, Manufacturing, QA/QC, Development, Regulatory Affairs, Research and Development, Validation

Level of Expertise: Executives, Management, Scientists/Technicians

Job Function: Scientist/Technician, Research, Analyst, Bench personnel

11:00 a.m. - 12:50 p.m.P7: Ask the Regulators – Expert Panel DiscussionModerator: Marla Stevens-Riley, PhD, Senior Review Microbiologist/Team Leader (Acting), CDER, FDA

This session will be structured in a question and answer format to allow for interactive discussion about topics related to the manufacturing of sterile drug products. The panel will consist of representatives from the FDA with a broad range of expertise, including cGMP field inspections and the review of chemistry, manufacturing, and controls information related to sterile drug products regulated by CDER and CBER.

Panelists:Dennis Guilfoyle, PhD, Microbiologist, Northeast Regional Laboratory, ORA, FDAPatricia Hughes, Team Leader for Biotech Manufacturing Branch, CDER, FDADavid Hussong, PhD, Associate Director of New Drug Microbiology, CDER Office of Pharmaceutical Science, FDA

12:50 p.m. Closing Remarks from Program Planning Committee Co-chairOsama Elrashidy, Associate Director, Quality Control, Bayer Healthcare Pharmaceuticals, Inc.




PDA’s Training and Research Institute (PDA TRI) Courses – October 24-25, 2013

Validation of Microbiological Test MethodsOctober 24, 2013 | Bethesda North Marriott Hotel PDA #353 | ACPE# 0116-0000-13-353-L04-P| 0.6 CEUsType of Activity: Knowledge

Course DescriptionThis course is designed to assist the Quality Assurance, Regulatory Compliance, Quality Control and Validation function with the validation of microbiological test methods using a step-by-step procedure. It will commence with a review of traditional and contemporary methods followed by new technologies. The course will then proceed to discuss the requirements to qualify a new instrument to include DQ/IQ/OQ/PQ. A large portion of the course will be spent discussing elements of a microbiological validation, reviewing of validation criteria and making recommendations for satisfying each element. The day will end with a discussion of microbiological Out of Specifications.

Who Should AttendThose who will benefit from this course include Quality Assurance, Regulatory Compliance, Quality Control and Validation professionals who are contemplating microbiological validations, as well as those already involved in these validations. Personnel involved in the technology transfer of early stage products will also benefit from the microbiological validation requirements to expedite the release of product during Phase 3 and following commercialization.

Learning ObjectivesUpon completion of this course, you will be able to:

• Identify the regulatory expectations for validation of microbiological methods

• Explain new technologies for microbiological testing • Explain the initial considerations required to meet the

microbiological validation plan design • Establish microbiological analytical procedures based on process/

product requirements • Develop acceptance limits for products, components and processes • Describe elements of a microbiological validation • Review of validation criteria and recommendations for satisfying

each as part of a microbiological validation • Utilize the application of TR No. 33 and USP <1223> to the

validation of microbiological methods • Improve process reliability • Improve product safety and reliability

InstructorBarry Friedman, PhD, Consultant, Barry A. Friedman, PhD, LLC

Investigating Microbial Data DeviationsOctober 24, 2013 | Bethesda North Marriott Hotel PDA #441 | ACPE# 0116-0000-12-441-L04-P | 0.6 CEUsType of Activity: Knowledge

Course DescriptionThis course will provide practical insights into both the regulatory and scientific considerations which must be taken when investigating microbiological data deviations. Participants will come away with an understanding not only of what the considerations are, but a practical approach of how to design and conduct investigations into microbiological test data that appears inconsistent with expectations and trends.

Who Should AttendThis course will be of value to quality control staff who conduct and assess the results of microbiological testing. It will also be of benefit for quality control and quality assurance staff who conduct investigations into microbiological data deviations and write and approve reports of those investigations. Analysts, laboratory supervisors, managers and quality assurance staff will all benefit from this course.

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

• Identify microbiological test results that deviate from anticipated results and trends

• Explain the responsibilities of laboratory, manufacturing and quality assurance staff in preparing for, conducting, reviewing and documenting investigations into microbiological data deviations

• Describe the essential elements of reports of investigations into microbiological data deviations

• Discuss the benefits of flowcharts, checklists and process flow diagrams as they apply to the investigation process

• Apply the concepts learned in situations involving microbiological data deviations when necessary.

InstructorJeanne Moldenhauer, Excellent Pharma Consulting

In conjunction with the PDA 8th Annual Global Conference on Pharmaceutical Microbiology, the PDA Training and Research Institute (PDA TRI) is offering three stand-alone courses related to the latest technologies and regulatory expectations in regards to microbiology. All courses will be held on October 24-25 at the:

Bethesda North Marriott Hotel and Conference Center 5701 Marinelli Road, Bethesda, MD 20852



PDA’s Training and Research Institute (PDA TRI) Courses – October 24-25, 2013 (continued)

General InformationThree Ways to Register1. Click www.pda.org/microbiology20132. Fax +1 (301) 986-10933. Mail: PDA Global Headquarters Bethesda Towers 4350 East West Highway, Suite 150 Bethesda, MD 20814 USA

VenueMarriott Bethesda North Hotel and Conference Center 5701 Marinelli Road, Bethesda, MD 20852Phone: +1 (301) 822-9200Website: www.marriott.com

Rate: Single: $239.00, plus applicable state and local taxes.

Cut Off Date: Sunday, September 22, 2013 (Rooms must be secured by this date in order to receive the PDA rate)

Conference Registration HoursSunday, October 20: 4:00 p.m. – 6:00 p.m.Monday, October 21: 7:00 a.m. – 5:15 p.m.Tuesday, October 22: 7:30 a.m. – 5:30 p.m.Wednesday, October 23: 7:00 a.m. – 12:50 p.m.

Course Registration HoursThursday, October 24: 7:30 a.m. - 4:00 p.m. Friday, October 25: 7:30 a.m. - 4:00 p.m.

Dress/AttireBusiness casual attire is recommended for PDA 8th Annual Global Conference on Pharmaceutical Microbiology. Since the temperature in meeting rooms tends to be cool, please bring a jacket or sweater for your comfort.

Special RequirementsIf 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 InformationConference inquiries: Jason E. Brown Senior Manager, Programs Meetings Tel: +1 (301) 656-5900 ext. 131 | E-mail: [email protected]

Registration inquiries: Tel: +1 (301) 656-5900 ext. 115 | E-mail: [email protected]

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

Exhibition/Sponsorship inquiries: David Hall, Vice President, Sales Tel: +1 (301) 656-5900 ext. 160; Direct: +1 (240) 688-4405 E-mail: [email protected]

Evaluation, Validation and Implementation of Alternative and Rapid Microbiological Testing MethodsOctober 24-25, 2013 | Bethesda North Marriott Hotel PDA #481 | ACPE# 0116-0000-13-481-L04-P | 1.2 CEUsType of Activity: Application

Course DescriptionThis new course is designed to provide attendees with an overview of the revised PDA Technical Report No. 33, Evaluation, Validation and Implementation of Alternative and Rapid Microbiological Testing Methods, and how the report can be used as the basis for the validation and implementation of alternative and rapid microbiological methods (RMMs). The format is a lecture presentation, but audience involvement will be highly encouraged. Significant changes to the original technical report, which was first published in 2000, will be described in great detail.

Who Should Attend• Senior management and laboratory personnel responsible for the

conduct of microbiological testing and microbial control strategies in manufacturing and product/process development

• Microbiology, Quality Control, Quality Assurance, Manufacturing, Validation, Regulatory Affairs, R&D, Discovery, Finance

• Directors, Managers/Supervisors, Scientists, Technicians, Operators, Auditors

Learning ObjectivesUpon completion of this course, you will be able to:

• Review the benefits of alternative and RMM technologies as compared with classical microbiological methods

• Describe the scientific basis for a variety of technologies that may be qualified as alternative methods to classical microbiology procedures

• Explain the regulatory environment, guidance, policies and expectations for validation, submissions and implementation

• Develop business plans and return on investment justifications • Apply industry best practices for validating these new

technologies by demonstrating that the methods are acceptable for their intended use via IQ, OQ and PQ qualification strategies

InstructorMichael J. Miller, PhD, President, Microbiology Consultants, LLC

Course Schedule:All lecture courses will begin at 8:30 a.m. and end at 4:00 p.m. A continental breakfast will be served before class beginning 7:30 a.m. Lunch will be provided from 12:00 – 1:00 p.m. Snacks will be provided during the morning break from 10:00 – 10:15 a.m. and the afternoon break from 2:30 – 2:45 p.m.

PDA 8th Annual Global Conference on Pharmaceutical MicrobiologyOctober 21-23, 2013 | Bethesda North Marriott Hotel | Bethesda, Maryland Exhibition: October 21-22 | Courses: October 24-25Registration is simple and fast... Click, fax or mail: Click: www.pda.org/microbiology2013 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:

Prefix 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.)

Campaign Code MicroBrochure

2 Conference Registration | October 21-23, 2013 Please check appropriate fee (US$).

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

Before August 9, 2013 $ 1,695 $ 1,944 $ 700 $ 800 $ 700 $ 800 $ 280 $ 310

August 9 – September 10, 2013 $ 1,895 $ 2,144 $ 700 $ 800 $ 700 $ 800 $ 280 $ 310

After September 10, 2013 $ 2,095 $ 2,344 $ 700 $ 800 $ 700 $ 800 $ 280 $ 310

Price On or Before September 10, 2013 Price After September 10, 2013

3 Course Registration | October 24-25, 2013

Please check appropriate fee (US$). StandardGovernment/Health Authority/Academic Standard

Government/Health Authority/Academic

Member Nonmember Member Nonmember Member Nonmember Member Nonmember#441 Investigating Microbial Data Deviations (October 24} $ 895 $ 1,165 $ 600 $ 700 $ 995 $ 1,295 $ 600 $ 700

#480 Evaluation, Validation and Implementation of Alternative and Rapid Microbiological Testing Methods (October 24-25)

$ 1,435 $ 1,705 $ 950 $ 1,050 $ 1,595 $ 1,895 $ 950 $ 1,050

#353 Validation of Microbiological Test Methods (October 24) $ 895 $ 1,165 $ 600 $ 700 $ 995 $ 1,295 $ 600 $ 700

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 be advised that if your payment or written cancellation notice is not received by August 22, 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 a non-member substituting for a member, you will be required to pay the difference non-member fee. If you are pre-registering as a substitute attendee, indicate this on the registration form. REFUNDS: Refund requests must be in writing and faxed to +1 (301) 986-1093. (Emails and phone messages are not accepted). Refunds for Full Conference/Events: If your written request in received on or before August 22, 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 cancel an event. If an event must be canceled, 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. REFUNDS FOR COURSES: If your written request is received by September 24, 2013, you will receive a full refund less a $200 processing fee. After that time, no refunds will be approved. 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 PDA 8th Annual Global Conference on Pharmaceutical Microbiology, 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

Special Dietary Requirements (Please be specific):

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.

* For this member type, online 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.

Register by August 10th and receive access to prior conference recordings for 60 days.

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.


PDA 8th Annual Global Conference on Pharmaceutical MicrobiologyOctober 21-23, 2013 Bethesda North Marriott Hotel | Bethesda, MarylandExhibition: October 21-22 | Course: October 24-25

Sponsorship and Exhibit Opportunities are Available! PDA 8th Annual Global Conference on Pharmaceutical Microbiology will provide your company the premier opportunity to gain access to and network with key decision makers from the pharmaceutical and biotech manufacturing industry. Make new contacts, discuss ongoing projects, and discover new opportunities by exhibiting at and/or sponsoring the industry’s leading conference and exhibition on global pharmaceutical microbiology. Many high profile, cost-effective sponsorship options are available to help your company increase exposure, build brand awareness, and stand out from the crowd.

Attendees will include industry professionals from manufacturing, engineering, compliance, quality, research and development, validation, regulatory affairs as well as executives, managers, scientists, technicians and analysts.

Exhibit space and sponsorships are filling up quickly so be sure to sign up today.

For more information about exhibit and sponsorship opportunities, please contact:David Hall, Vice President, Sales Direct: +1 (301) 656-5900 ext. 160 | Direct: +1 (240) 688-4405 | E-mail: [email protected]

PDA Global Headquarters4350 East West HighwaySuite 1500Bethesda, MD 20814 USATel: +1 (301) 656-5900Fax: +1 (301) 986-1093

PDA 8th Annual Global Conference on Pharmaceutical MicrobiologyOctober 21-23, 2013 Bethesda North Marriott Hotel Bethesda, MarylandExhibition: October 21-22 Course: October 24-25


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