Post on 13-Mar-2020
DECEMBER 4-6, 2019 | WYNDHAM PHILADELPHIA HISTORIC DISTRICT | PHILADELPHIA, PA
IVT NETWORK PRESENTS
CHOOSE FROM 21 INTERACTIVE COURSES AND CRITICAL DISCUSSIONS, INCLUDING:• Smart Innovation and the Future of Intelligent Labs
• Paperless Labs, ELN and Big Data
• Validation and Transfer — Acceptance Criteria Setting and Assessment
• Analytical Methods for Commercial Launch of Biologics
• Measuring Risk and System Capabilities with Case Studies of Equipment Failure and Lessons Learned
• Data Integrity for Stability Function
• Preparing for the FDA’s Audits and Inspections
• Risk Management for Computerized Systems
• QbD Mindset for Method Transfer and Qualification
• Forced Degradation Studies Using “Good Science”
• Need-to-Know Compliance, In and Outside the Lab
FEATURING TWO CONFERENCE SUMMITSStatistics in Validation — Focused Tools for the Practical Lab
Pharmaceutical Stability Discussion Group (PSDG) Sampler — Stability Assessment and Benchmarking Progress
A division ofUBM AmericasWWW.CBINET.COM/LABWEEK
R E G I S T E R N O W !
REGISTER BY OCTOBER 25, 2019 AND SAVE $300
EXPERIENCE EXCHANGEData Integrity Mock Inspection — Mitigating Risk
Bring Your Own Challenge (BYOC) Workshop — Horror Edition
Office Hours — An Opportunity to Get Questions Answered by Expert Speaking Faculty
IVT NETWORK’S
Data Integrity Method Transfers and Validation Stability TestingDECEMBER 4-6, 2019 | WYNDHAM PHILADELPHIA HISTORIC DISTRICT | PHILADELPHIA, PA
PLUS! Extend Your Learning Opportunity to Include a One Day Training CourseGMP Oversight in the QC Laboratory Tuesday, December 3, 2019
This intensive, full-day course uses real inspection findings, warning letters, 483 and audit findings, to identify Critical Control Points in the laboratory. Get a jump start on Lab Week!
FDA KEYNOTE ADDRESSThe Regulatory A-Z of Analytical MethodsSangeeta M. Khurana, Ph.D., Interdisciplinary Scientist/Investigator (GDUFA), Office of Pharmaceutical Quality Operations (OPQO) – Division 4, Office of Medical Products and Tobacco Operations, ORA, U.S. Food and Drug Administration (FDA)
DAY ONE | WEDNESDAY, DECEMBER 4, 20197:30 Conference Registration and Continental Breakfast
8:30 Choose from Two Summits (1-2)
1. Statistics in Validation — Focused Tools for the Practical LabAlan Golden, Principal, Design Quality Consultants, LLC, formerly Principal Quality Professional, Abbott Molecular
2. Pharmaceutical Stability Discussion Group (PSDG) Sampler — Stability Assessment and Benchmarking ProgressJohn O’Neill, MS, RPh, Stability Information Specialist, StabilityHub
12:00 Networking Luncheon
1:00 Chairperson’s Welcome and Opening RemarksShilpi Guliani, Associate Director, IT Quality Engineering, Gilead Sciences
1:15
FDA KEYNOTE ADDRESS The Regulatory A-Z of Analytical MethodsSangeeta M. Khurana, Ph.D., Interdisciplinary Scientist/Investigator (GDUFA), Office of Pharmaceutical Quality Operations (OPQO) – Division 4, Office of Medical Products and Tobacco Operations, ORA, U.S. Food and Drug Administration (FDA)
2:00 Smart Innovation; Intelligent Labs — Key Points to Consider in the Lab of the FutureShilpi Guliani, Associate Director, IT Quality Engineering, Gilead Sciences
3:00Networking and Refreshment Break Office Hours — Meet One-on-One with Speaking Faculty to Discuss Your Unique ChallengesKaren Ginsbury, BPharm, MSc, Founder and CEO, PCI Pharma Ltd.
3:30Paperless Lab, Electronic Lab Notes (ELN) & Big Data — DigitizationSheba Zaman, Head of Product Specialists and Training Services, Novatek InternationalKaren Ginsbury, BPharm, MSc, Founder and CEO, PCI Pharma Ltd.
5:00 Close of Day One | Networking, Wine and Cheese Reception Commences
DAY TWO | THURSDAY, DECEMBER 5, 2019 8:00 Continental Breakfast
8:30 CHOOSE FROM TWO CONFERENCE TRACKS (1-2)
METHOD TRANSFERS AND VALIDATION 1. A Two-Part Method Transfer and Validation Perspective
Balaji Viswanathan, Ph.D., Principal Scientist Method Validation, Validation and Analytical Technology Transfer (VATT), Biotherapeutics Pharmaceutical Sciences, Pfizer IncAili Cheng, Pharm Sci & PGS Statistics, Worldwide Research and Development, Pfizer Inc
STABILITY TESTING 2. Advanced Modeling with an Accelerated
Stability Assessment Program (ASAP) to Determine Product Shelf-lifeMaria Krisch, Ph.D., Senior Scientist, FreeThink Technologies, Inc.
10:00 Networking and Refreshment Break
10:30 CHOOSE FROM TWO CONFERENCE TRACKS (3-4)
METHOD TRANSFERS AND VALIDATION 3. Measuring Risk with Systems Capabilities —
Equipment Failures, Compliance Workarounds and Out-of-the-Box SolutionsKaren Ginsbury, BPharm, MSc, Founder and CEO, PCI Pharma Ltd.
DATA INTEGRITY & STABILITY TESTING 4. Data Integrity for the Stability Function
John O’Neill, MS, RPh, Stability Information Specialist, StabilityHub
12:00 Networking Luncheon
AGENDA-AT-A-GLANCE
1:00 CHOOSE FROM TWO CONFERENCE TRACKS (5-6)
METHOD TRANSFERS AND VALIDATION 5. Risk-Based Continued Test Method Performance Verification
Ronald D. Snee, Ph.D., President, Consultant, Snee Associates, LLC
STABILITY TESTING 6. Stability Studies Design — Support for Early
Clinical DevelopmentGeoff Carr, Director of Analytical Development, Ontario, Patheon by Thermo Fisher Scientific
1:45 CHOOSE FROM THREE CONFERENCE TRACKS (7-9)
METHOD TRANSFERS AND VALIDATION 7. Reading the FDA’s Mind — Preparing
for FDA Audits and InspectionsJane Weitzel, Ms., Independent Consultant
STABILITY TESTING 9. From R&D to Commercialization —
Implementing GMP-Level Standards Early for More Efficient Product TransitionsEmily Trubee, Stability Manager, R&D, ADARE Pharmaceuticals
DATA INTEGRITY 8. Risk Management for
Computerized SystemsAbhishek Bachchan, Senior Manager, Global IT Compliance, ThermoFisher Scientific
2:30Networking and Refreshment Break Office Hours — Meet One-on-One with Speaking Faculty to Discuss Your Unique ChallengesKaren Ginsbury, BPharm, MSc, Founder and CEO, PCI Pharma Ltd.
3:00 Data Integrity Mock Inspection — Mitigating Risk Alyce Deegan, Vice President of Data Integrity Practice, Compliance Path LLC
4:30 Close of Day Two
DAY THREE | FRIDAY, DECEMBER 6, 2019 8:00 Continental Breakfast
8:30Bring Your Own Challenge (BYOC) Workshop — Horror EditionJohn O’Neill, MS, RPh, Stability Information Specialist, StabilityHubGeoff Carr, Director of Analytical Development, Ontario, Patheon by Thermo Fisher Scientific
10:00Networking and Refreshment Break Office Hours — Meet One-on-One with Speaking Faculty to Discuss Your Unique ChallengesEmily Trubee, Stability Manager, R&D, ADARE Pharmaceuticals
10:30 CHOOSE FROM THREE CONFERENCE TRACKS (10-12)
METHOD TRANSFERS AND VALIDATION 10. Quality by Design (QbD) Mindset for
Method Transfer and QualificationJane Weitzel, Ms., Independent Consultant
STABILITY TESTING 12. Preparing for Audits and Inspections
of the Stability ProgramEmily Trubee, Stability Manager, R&D, ADARE Pharmaceuticals
DATA INTEGRITY 11. Building a Lab to Be FDA
Inspection-Ready in One YearLibby Russell, Senior Vice President, Neva Analytics
12:00 Networking Luncheon
1:00 CHOOSE FROM TWO CONFERENCE TRACKS (13-14)
METHOD TRANSFERS AND VALIDATION 13. Balancing Regulatory Requirements and Business Criticalities
Ben Zarza, Site Validation Manager, ThermoFisher Scientific
STABILITY TESTING 14. Forced Degradation Studies — Applying Good Science and
Regulatory Guidelines to Maximize EfficiencyGeoff Carr, Director of Analytical Development, Ontario, Patheon by Thermo Fisher Scientific
2:00 Close of Conference
AGENDA-AT-A-GLANCE
Want to know what your colleagues in other companies/countries are doing? Not quite sure if your practices or protocols are what a regulator is looking for?
• Benchmark current industry practices, poll your fellow participants on your questions and discuss the hottest stability issues of the day, including all aspects of stability, laboratory and operations information.
• To get the most out of this summit, come prepared to share non-proprietary information about your stability program and practices during this highly interactive, topic-rich session.John O’Neill, MS, RPh, Stability Information Specialist, StabilityHub
SUMMIT 1 | Statistics in Validation — Focused Tools for the Practical Lab
SUMMIT 2 | Pharmaceutical Stability Discussion Group (PSDG) Sampler — Stability Assessment and Benchmarking Progress
In this summit, we discuss the common statistics tools and techniques used in validation. Through real-world examples and interactive exercises, we demonstrate the basic concepts of statistics and how to apply them to your validation projects. We then explore setting up statistically valid sampling plans for process validation and using those plans to set acceptance criteria. Setting acceptance criteria for test method validation is also discussed.
PART 1: Basic Statistics for Non-StatisticiansI. Introduction
• What is statistics• Why do you need statistics for validation?• Regulatory expectations
II. The Concept of Variance (and Why It Is Important)• Sources of variance• Measuring variance• Normal and non-normal distributions • Measuring variance
III. Expressing Variance• Variance
• Standard deviation
• Interactive exercise — Measuring variance
• Coefficient of variation
IV. Process Capability• Can your system do what you want (need)
it to do?
• Measuring capability
• Using capability to set acceptance criteria for validation
PART 2: Validation Sampling Plans and Setting Acceptance Criteria for Process and Test Method ValidationI. What Is Sampling?
• Sampling is the ability to make a quality determination on a large number of things without direct examination of each thing
II. Validation Sampling• Not the same as lot acceptance sampling
III. Setting up a Validation Sampling Plan• Five step method
IV. Using Sampling Plans to Set Acceptance Criteria for Process Validation
V. The Concept of Acceptance Criteria in Test Method Validation• Variance, how much is too much• How to measure variance and why
VI. Use of Process Capability • The concept of process capability• Cp vs CpK• How to use process capability to set
acceptance criteria for test method validation
VII. Statistical Process ControlsAlan Golden, Principal, Design Quality Consultants, LLC, formerly Principal Quality Professional, Abbott Molecular
*There will be a 30-minute networking and refreshment break at 10:00am
*There will be a 30-minute networking and refreshment break at 10:00am
12:00 Networking Luncheon
1:00 Chairperson’s Welcome and Opening RemarksShilpi Guliani, Associate Director, IT Quality Engineering, Gilead Sciences
1:15 FDA KEYNOTE ADDRESS The Regulatory A-Z of Analytical MethodsKeeping up-to-date with global regulations is increasingly challenging. This distills the most recent information into a short, sharp list of discussion points. Included in the presentation:
I. Updated Guidance: • ICH Q12: Lifecycle Management of Analytical Procedures • ICH Q14: Analytical Methods Development and Validation
II. Regulatory Expectations
III. Designing an Analytical Procedure for Data Governance
IV. Audit Trail Hotspots and Compliance BreakdownSangeeta M. Khurana, Ph.D., Interdisciplinary Scientist/Investigator (GDUFA), Office of Pharmaceutical Quality Operations (OPQO) – Division 4, Office of Medical Products and Tobacco Operations, ORA, U.S. Food and Drug Administration (FDA)
2:00 Smart Innovation; Intelligent Labs — Key Points to Consider in the Lab of the Future• Discuss a continuous compliance mindset —
Designing automation to uphold standards• Review how to be more compliant in an Intelligent Lab• Explore how to extend digitized qualification to storage spaces —
Next step, cloud compliance• Interactive discussion with audience inputShilpi Guliani, Associate Director, IT Quality Engineering, Gilead Sciences
3:00 Networking and Refreshment Break
Office Hours Meet one-on-one with speakers to discuss your unique laboratory challenges.
Karen Ginsbury, BPharm, MSc, Founder and CEO, PCI Pharma Ltd. Sangeeta M. Khurana, Ph.D., Interdisciplinary Scientist/Investigator (GDUFA), Office of Pharmaceutical
Quality Operations (OPQO) – Division 4, Office of Medical Products and Tobacco Operations, ORA, U.S. Food and Drug Administration (FDA)
3:30 Paperless Lab, Electronic Lab Notes (ELN) and Big Data — DigitizationThis session looks at Electronic Laboratory Notebooks with an integrated, digitized laboratory — Electronic signatures and records, electronic audit trail review, electronic reagent and standard management
• In addition to studying advantages, known compliance pitfalls are reviewed during an interactive brainstorming session with participants
• Kiss stand-alone goodbye! This is the way forward — If you want to be part of the vision, you have to come to this session
Sheba Zaman, Head of Product Specialists and Training Services, Novatek International Karen Ginsbury, BPharm, MSc, Founder and CEO, PCI Pharma Ltd.
5:00 Close of Day One
Join Us for a Networking Wine and Cheese Reception at the Close of Day One
DAY ONE WEDNESDAY, DECEMBER 4, 2019
8:30 CHOOSE FROM TWO MORNING OPTIONS7:30 Conference Registration and Continental Breakfast
DAY TWO THURSDAY, DECEMBER 5, 20198:00 Continental Breakfast
8:30 CHOOSE FROM TWO CONFERENCE TRACKS (1-2)
Part 1 — Validation and Transfer of Analytical Methods for Biologics to Enable Commercial LaunchI. Pre-Validation Activities and Method
Assessments• Method risk assessment prior to
process validation• Working across multiple modalities in a
global network • Keys to success — Planning, considerations
and feasibility training
II. Background of Biologic Process Performance Qualification and Development of Analytical Master Validation Plan• Process performance qualification and
in-process testing strategy• Categorization of samples and
validation approach• Generating an analytical master
validation plan
III. Validation Protocol, Experimental Design and Validation Report• Validation protocol — What to include, and
what not• Setting validation acceptance criteria
and statistics• Experimental design• Validation report — Deviations,
documentation and assessment
IV. Life Cycle Management, BLA Authoring, and Global Filings• Lessons learned• Analytical method summaries and
registration filing• Commercial specification setting• Lifecycle managementBalaji Viswanathan, Ph.D., Principal Scientist Method Validation, Validation and Analytical Technology Transfer (VATT), Biotherapeutics Pharmaceutical Sciences, Pfizer Inc
Part 2 — A Practical Approach to Method Transfer Acceptance Criteria Setting and AssessmentI. Statistical Assessment for
Method TransferII. Acceptance Criteria Setting Based
on the Method Precision• The related specification limits and realistic
sample size for each lab
III. Practical Statistical Strategies for Different Method Transfer Situations
Aili Cheng, Pharm Sci & PGS Statistics, Worldwide Research and Development, Pfizer Inc
A Two-Part Method Transfer and Validation Perspective
METHOD TRANSFERS AND VALIDATION
1
• Examine accelerated stability modeling through its capabilities and limits
• Understand how short-term (~3 week) data collected under highly stressed conditions can be used to build a predictive shelf-life model under storage conditions
• Review the basis of modeling with the humidity-corrected Arrhenius equation
• Study the concept of “isoconversion” and how it aids prediction
• Hear a case study of an accelerated model for chemical stability compared to real-time stability data
• Briefly review how accelerated stability is used in regulatory filings
BONUS MATERIALWhite Papers on Accelerated Stability:1. Science of Temperature Impact on Degradation 2. Science of Humidity Impact on Degradation
Rates in Solids
Maria Krisch, Ph.D., Senior Scientist, FreeThink Technologies, Inc.
Advanced Modeling with an Accelerated Stability Assessment Program (ASAP) to Determine Product Shelf-life
STABILITY TESTING
2
10:00 Networking and Refreshment Break
10:30 CHOOSE FROM TWO CONFERENCE TRACKS (3-4)
Measuring Risk with Systems Capabilities — Equipment Failures, Compliance Workarounds and Out-of-the-Box Solutions
METHOD TRANSFERS AND VALIDATION
3• Examine microbiologic labs, equipment
location and failures• Assess room classifications• Discuss equipment needs and location
• Address the facility design and intended results
• Dissect equipment failures and possible solutions
Karen Ginsbury, BPharm, MSc, Founder and CEO, PCI Pharma Ltd.
• Review data integrity trends and how they may impact the Stability function
• Address the historically problematic integrity of “paper-based” outputs
• Assess regulatory inspections and multiple guidances from across the globe for Stability DI implications
• Explore where risks can arise from non-traditional sources like stability chambers, test instruments and sample pull calendars
• Discuss how to apply data integrity measures to the Stability function
John O’Neill, MS, RPh, Stability Information Specialist, StabilityHub
Data Integrity for the Stability Function
DATA INTEGRITY & STABILITY TESTING
4
12:00 Networking Luncheon
1:00 CHOOSE FROM TWO CONFERENCE TRACKS (5-6)
Risk-Based Continued Test Method Performance Verification
METHOD TRANSFERS AND VALIDATION
5• FDA and USPs call for improved measurement
data integrity and quality through continued method performance verification (CMPV) over its lifetime
• ICH Q9 Quality Risk Management focus on risk analysis and mitigation as part of the quality processes
• Need for a systems approach to control and reduce variation and risk and sustain method performance over time
• Tools for assessing test method performance stability, capability, repeatability, reproducibility and risk reduction
• Data for assessing test method performance — Use of control/reference samples and product stability data
• Systems approach for CMPV — Organization, management’s role and integrated tool set
• Session includes case studies, examples and tips and traps
Ronald D. Snee, PhD, President, Consultant, Snee Associates, LLC
• Understand differences between stability studies in clinical development and registration/commercial stability programs
• Examine an example of stability study design for a Phase 1 Powder in Bottle Product
• Assess study design for a Phase 2 product including preparation for Phase 3 and registration stability
• Learn about studies required in support of blinded clinical programs
• Review how to deal with placebos and blinded comparator products
Geoff Carr, Director of Analytical Development, Ontario, Patheon by ThermoFisher Scientific
Stability Studies Design — Support for Early Clinical Development
STABILITY TESTING
6
2:30 Networking and Refreshment Break
1:45 CHOOSE FROM THREE CONFERENCE TRACKS (7-9)
Reading the FDA’s Mind — Preparing for FDA Audits and Inspections
METHOD TRANSFERS AND VALIDATION
7Focusing on “Fit for intended use” of your method will help you understand FDA expectations for a method. The Quality by Design (QbD) approach provides such a focus. This presentation will explain how current FDA expectations align with QbD. Recent guidances and communications from the FDA will be reviewed. Use the understanding of your method and its control strategy to prepare for an FDA inspection.
• Review the recent FDA guidances and communications that identify FDA expectations
• Explore how the QbD process provides method understanding
• Utilize the QbD approach to present your method during and FDA inspection
• Prepare and optimize for an inspection at any time
BONUS MATERIALEXCEL spreadsheet to present “Fit for Intended Use”
Jane Weitzel, Ms., Independent Consultant
This session will focus on a holistic and flexible risk management approach for computerized systems. We will go over various aspects of risk assessment and management including the following:
I. Regulatory Impact Assessment II. Data Integrity Risk Management III. Functional Risk Assessment IV. Data and Electronic Signature
Management
V. IT Supplier Risk Management
VI. Risk Based Validation
VII. Risk Based MaintenanceAbhishek Bachchan, Senior Manager, Global IT Compliance, ThermoFisher Scientific
Risk Management for Computerized Systems
DATA INTEGRITY
8
• Outline the general development process and subsequent transition into the commercial space
• Documentation and review of laboratory data
• Using data trending and reporting • Using ‘best practices’ during method
development and validation
• Generating detailed batch histories and control charts
Emily Trubee, Stability Manager, R&D, ADARE Pharmaceuticals
From R&D to Commercialization — Implementing GMP-Level Standards Early for More Efficient Product Transitions
STABILITY TESTING
9
3:00 Data Integrity Mock Inspection — Mitigating Risk This popular session uses warning letters, 483s and (anonymized) real inspection transcripts to act out a data integrity inspection. Our experienced facilitator shows the audience common lab searches both digitally and physically, as well as wrong inspection responses and behaviors which participants identify and then act out a correct way to handle the same situation. By observing the role play and sharing their own experience, the facilitator and participants have fun and come away with a greatly strengthened inspection handling approach.
FACILITATOR/MOCK INSPECTOR:Alyce Deegan, Vice President of Data Integrity Practice, Compliance Path LLC
4:30 Close of Day Two
Office Hours Meet one-on-one with speakers to discuss your unique laboratory challenges.
Karen Ginsbury, BPharm, MSc, Founder and CEO, PCI Pharma Ltd.
DAY THREE FRIDAY, DECEMBER 6, 20191:00 CHOOSE FROM TWO CONFERENCE TRACKS (5-6)
2:30 Networking and Refreshment Break
1:45 CHOOSE FROM THREE CONFERENCE TRACKS (7-9)
4:30 Close of Day Two
8:00 Continental Breakfast
8:30 Bring Your Own Challenge (BYOC) Workshop — Horror EditionDuring this much-loved workshop, laboratory professionals share their specific pain points when it comes to interacting with colleagues who are not part of the “Laboratory Neighborhood,” but who impact compliance in the lab. Participants will brainstorm solutions for prevention and for resolving identified breaches of compliance where someone outside the lab’s control, outside of their “neighborhood,” caused a significant failure in the lab’s GMP compliance. We encourage you to bring a current and unique challenge to be worked through during this real-life, discussion-driven session; to brainstorm take-home solutions for one of the most pervasive issues affecting labs today.
John O’Neill, MS, RPh, Stability Information Specialist, StabilityHubGeoff Carr, Director of Analytical Development, Ontario, Patheon by Thermo Fisher Scientific
10:30 CHOOSE FROM THREE CONFERENCE TRACKS (10-12)
Quality by Design (QbD) Mindset for Method Transfer and Qualification
METHOD TRANSFERS AND VALIDATION
10Design for success — that is the mindset for method qualification and method transfers that QbD brings. The Quality by Design (QbD) philosophy and approach are focused on achieving a clear, complete and concise understanding of the method. This ensures that the method is fit for its intended use. If the method needs to be transferred, QbD provides the information for a smooth, successful method transfer.
This presentation provides an overview of QbD for a method. Then it will discuss in greater detail the critical steps that QbD includes and are often missed. When the QbD philosophy of first understanding and then controlling a method are implemented, the mindset becomes one of success.• Assess the philosophy of QbD• Examine how a method qualification
follows QbD
• Learn how to “First Seek to Understand” your method
• Utilize lessons learned to control the method• Apply knowledge to successfully transfer
a method
BONUS MATERIALEXCEL spreadsheet to help understand your method.
Jane Weitzel, Ms., Independent Consultant
Starting up a laboratory involves significant resources in both time and capital — doing this while also supporting initial GMP projects requires risk-based prioritization. Although the FDA can inspect at any time, we received our first unannounced general GMP systems inspection just one year after registering the establishment. Inspections lessons learned highlight the
outcomes of our risk-based prioritization approach to establishing our GMP operations. This session provides a subjective look at the components of starting up a successful GMP lab and the lessons learned from our FDA inspection.• Understand the requirements and challenges
of starting up a GMP analytical lab
• Use risk-based prioritization to: develop quality systems, establish equipment capability; generate documentation
• Managing an unannounced inspection• What the FDA focused on
Libby Russell, Senior Vice President, Neva Analytics
Building a Lab to Be FDA Inspection-Ready in One Year
DATA INTEGRITY
11
• Why inspections are a critical part of a compliant stability program
• Common areas for audit and inspection observations
• Tips for hosting a successful audit or inspection
• Review of recent warning letters
Emily Trubee, Stability Manager, R&D, ADARE Pharmaceuticals
Preparing for Audits and Inspections of the Stability Program
STABILITY TESTING
12
12:00 Networking Luncheon
10:00 Networking and Refreshment Break
Office Hours Meet one-on-one with speakers to discuss your unique laboratory challenges.
Emily Trubee, Stability Manager, R&D, ADARE Pharmaceuticals
Balancing Regulatory Requirements and Business Criticalities
METHOD TRANSFERS AND VALIDATION
13Companies must continuously adapt to changing regulatory requirements while effectively managing the associated costs and resources required to meet and fulfill regulatory requirements.
I. Typical Issues• Tailor new product strategy from
development to new markets with an eye to location-specific regulations
• Establish quality controls, standards and procedures with a deep understanding of local practices and regulatory requirements
• Manage requirements with numerous conflicting demands and pressures caused by the market, competition, changes in technology and regulations
II. Regulatory Compliance — Where Does It Apply?• Review compliance at every stage of the
regulated product lifecycle, from pre-clinical research to market authorization and from market authorization to commercialization
• Assess all groups involved in research, pre-clinical testing, clinical development, dossier preparation and submission, manufacturing, distribution, marketing and post-approval activities
• Highlight compliance at a local, regional, international and even global level
III. Challenges for Regulatory Compliance• Examine costly failed regulatory inspections,
data falsification and quality issues examples• Discuss companies still dealing with
implementation of required corrective actions many years past the original audits and inspection
IV. Impact of Non-Compliance to Regulatory Requirements• Study the impact of failed compliance beyond
the monetary impact to factors like reputation and future business relationships
• Explore how to win back the confidence of ex-customers and prospects in the face of regulatory failures
• Assess other long-term follow-on impacts that compound losses including delays to product approval and market uptake, product recalls, import bans, invalidation of clinical trial results, consent decrees that result in loss of control of manufacturing facilities and dwindling market share
• Examine the possibility of acquisitive competitors
V. The Initiatives and Required Competencies that Companies Must Excel at to Be Successful Due to On-Going Changes in Regulatory Requirements• What can companies do to ensure that
compliance is maintained at all times and across every aspect of the business that requires adherence to regulations?
Ben Zarza, Site Validation Manager, ThermoFisher Scientific
1:00 CHOOSE FROM TWO CONFERENCE TRACKS (13-14)
• Assess the complexities of degradation chemistries under various environmental stresses
• Understand the regulatory requirements for the application of stability indicating analytical procedures for testing stability samples
• Examine a relatively recent Forced Degradation Study guideline issued by ANVISA, Brazil Agency in Resolution RDC n° 53/2015 and its impact on study design
• Review a practical approach for addressing different stress conditions in a forced degradation study
• Learn how to conduct analytical testing of stressed samples
• Discuss importance of how forced degradation data are processed and interpreted
Geoff Carr, Director of Analytical Development, Ontario, Patheon by ThermoFisher Scientific
Forced Degradation Studies — Applying Good Science and Regulatory Guidelines to Maximize Efficiency
STABILITY TESTING
14
2:00 Close of Conference
CONFERENCE SPONSORS
IVT's Lab Week convenes the life sciences industry's leading experts responsible for implementing, managing and driving their organization’s quality and validation program. Capitalize on the opportunity
to network, exchange ideas and share solutions throughout the conference. For more information, contact Steve Markos at +1 339-298-2108 or email at steven.markos@cbinet.com.
WWW.CBINET.COM/LABWEEK
GMP Oversight in the QC Laboratory
Meets the Requirements for Annual GMP Trainingfor Supervisors and Analysts
One Day Training Course
DECEMBER 3, 2019 • PHILADELPHIA, PAIVT’s One Day Training Course — GMP Oversight in the QC Laboratory — A uniquely tailored course for supervisors, team leaders, data review managers and analysts who want to understand the supervisory role. This intensive, all-day course uses real inspection findings, warning letters, 483 and audit findings, to identify Critical Control Points in the laboratory. Through understanding the risks, participants will gain increased awareness of the controls they already have in place and how to monitor them. Analysts, supervisors and team leaders benefit from the facilitator’s experience to gain perspectives on inspection handling.
Detailed Information on How to Improve Compliance and Reduce Regulatory Inspection Exposure, Including:• Laboratory Data Governance/Data Integrity
> Audit Trail Review> Electronic Laboratory Notebooks vs. Manual, Paper, Worksheets> Review of Results (Notebooks, Worksheets, Instrument Output)
• Laboratory Oversight > Conducting Effective Internal Audits and CAPA> Hosting Regulatory Inspections
• Lifecycle Management of Analytical Methods > Method Development> Method Qualification/Validation/Verification> Continued Methods Verification
• Review of Regulations and Guidance• Qualification of New Hires/Maintaining Team Competency• Review of Analytical Instrument Qualification (AIQ)• Reference Standards and Materials, Reagents Management• Pharmacopeial and Regulatory Update• Statistical Process Control (SPC) of Analytics• Oversight of Stability Programs• ICH Quality Guidances 1–14 — Are You Proficient?• Pharma 4.0 Laboratory Vision for 2025
Don’t miss this rare opportunity to hear one of IVT’s top faculty members give a structured, in-depth review of what an analyst, lab supervisor or team leader needs to do his/her job. Sign up today!
Course Faculty:Karen Ginsbury, BPharm, MSc has more than 30 years of experience in setting up, maintaining and improving GMP compliant quality systems, including working intensely with Quality Control Laboratories.
Karen has run her own consultancy company for more than 25 years, steering clients through FDA, EU, Health Canada and other regulatory inspections; helping companies avoid warning letters, by rapid and effective response to 483 findings, performing hundreds of audits around the world, almost all including laboratories.
As a regular lecturer at IVT and other professional conferences and events, Karen regularly surveys participants to benchmark best practices and share her experience. A highly interactive lecturer, she is always current and interesting.
Expand Your Learning Opportunity and Join Us on December 3, 2019 • Philadelphia, PA
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MEDIA PARTNERS:
11TH ANNUAL
EUROPE INDUSTRY’S LEADER IN GLOBAL VALIDATION
21-23 MAY 2020 • AMSTERDAM, THE NETHERLANDS
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APRIL 29 – MAY 1, 2020 • PHILADELPHIA, PA
ITand Computerized Systems Validation WeekDriven by the Regulatory Expectations of Today and the Technologies of Tomorrow
UPCOMING E VENTS
ATTENDEE ACCLAIM:
“Absolutely loved the mock inspection.”
– Senior Manager, QC Operations, CDMO, Ajinomoto Bio-Pharma Services
“Content was spot on. Real world experience. Style was engaging and kept my attention.”
– Informatics Field Marketing Manager, Waters Corporation
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VENUE
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SUBSTITUTION & CANCELLATION
Your registration may be transferred to a member of your organization up to 24 hours in advance of the conference. Cancellations received in writing on or before 14 days prior to the start date of the event will be refunded, less a $499 administrative charge. No refunds will be made after this date; however, the registration fee less the $499 administrative charge can be credited to another IVT conference if you register within 30 days from the date of this conference to an alternative IVT conference scheduled within the next six months. In case of conference cancellation, IVT’s liability is limited to refund of the conference registration fee only. IVT reserves the right to alter this
program without prior notice. Please Note: Speakers and agenda are subject to change. In the event of a speaker cancellation, every effort to find a suitable replacement will be made. The opinions of the conference faculty do not necessarily reflect those of the companies they represent or IVT.
*Events beyond our control include: severe weather conditions, natural and man-made disasters and any other similar events.
ACCOMMODATIONS
To receive IVT’s discounted hotel rate online, visit www.cbinet.com/labweek
Book Now! For hotel room availability and direct booking links, please visit www.cbinet.com/labweek and select the Venue-Pricing tab. Rooms are limited so please book early. All travel arrangements are subject to availability.
GROUP RATE
Looking to bring your team? Contact Information Services to learn about potential group savings. Contact John Schafer at 339-298-2215 or john.schafer@cbinet.com
* Advantage pricing rates do apply when applicable.
Offer may not be combined with any other special
pricing promotions. Offer may be used at CBI
co-located events.
SATISFACTION GUARANTEED
IVT stands behind the quality of its conferences. If you are not satisfied with the quality of the conference, a credit will be awarded towards a comparable CBI/IVT conference of your choice. Please contact 800-817-8601 for further information. Advanced preparation for IVT conferences is not required.
Fee includes continental breakfast, lunch, wine and cheese reception, refreshments and conference documentation. Credit Card (Visa, MC, AMEX, Discover) or checks accepted. Please make checks (in U.S. funds drawn on a U.S. bank) payable to: CBI. (No personal checks accepted.)
PLEASE NOTE: All advertised discounts are taken from the final, Standard Rate.
WEDNESDAY, DECEMBER 4, 20198:30 Summit Option 1 2
THURSDAY, DECEMBER 5, 2019
8:30–10:00 1 2
10:30–12:00 3 4
1:00–1:45 5 6
1:45–2:30 7 8 9
FRIDAY, DECEMBER 6, 2019
10:30–12:00 10 11 12
1:00–2:00 13 14
CHOOSE BREAKOUT SESSIONS:
PI19081
Advantage Pricing
Register by 10/25Standard Onsite
Conference $2599 $2899 $2999
Conference + GMP Training Dec 3 $3099 $3399 $3499
PRICING
3 EASY WAYS TO REGISTERWEBSITE: cbinet.com/labweek • PHONE: 800.817.8601 • EMAIL: cbireg@cbinet.com
W W W . C B I N E T . C O M / L A B W E E K
MEDIA PARTNERS:
DE
CE
MB
ER
4-6
, 2019
| WY
ND
HA
M P
HILA
DE
LPH
IA H
ISTOR
IC D
ISTR
ICT
| PH
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ELP
HIA
, PA
IVT
NE
TW
OR
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SE
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A division of
UB
M A
mericas
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W.C
BIN
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BW
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SA
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$3
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A division ofUBM Americas
CBI 70 Blanchard Road Burlington, MA 01803
REGISTER BY OCTOBER 25, 2019 AND
SAVE $300!IV
T NETW
OR
K’S
Data Integrity M
ethod Transfers and Validation Stability TestingD
EC
EM
BE
R 4-6, 2019 | W
YN
DH
AM
PH
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ELP
HIA
HIS
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IVT NETWORK’S
Data Integrity Method Transfers and Validation Stability TestingDECEMBER 4-6, 2019 | WYNDHAM PHILADELPHIA HISTORIC DISTRICT | PHILADELPHIA, PA
CH
OO
SE
FR
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21 INTE
RA
CTIV
E C
OU
RS
ES A
ND
C
RITIC
AL D
ISCU
SSION
S, IN
CLU
DIN
G:
• Sm
art Innovatio
n and the F
uture of Intellig
ent Lab
s
• Pap
erless Lab
s, ELN
and B
ig D
ata
• Valid
ation and
Transfer — A
cceptance C
riteria Setting
and
Assessm
ent
• Analytical M
ethod
s for C
om
mercial L
aunch of B
iolo
gics
• Measuring
Risk and
System C
apab
ilities with C
ase Stud
ies o
f Eq
uipm
ent Failure and
Lessons Learned
• Data Integ
rity for the S
tability F
unction
• Prep
aring fo
r the FD
A’s A
udits and
Inspectio
ns
• Risk M
anagem
ent for C
om
puterized
Systems
• Qb
D M
indset fo
r Metho
d Transfer and
Qualifi
cation
• Fo
rced D
egrad
ation S
tudies U
sing “G
oo
d S
cience”
• Need
-to-K
now
Co
mp
liance, In and O
utside the L
ab
FE
AT
UR
ING
TW
O
CO
NF
ER
EN
CE
SU
MM
ITS
Statistics in Valid
ation —
Fo
cused To
ols fo
r the P
ractical Lab
Pharm
aceutical Stability D
iscussion G
roup
(P
SD
G) S
amp
ler — Stab
ility Assessm
ent and
Benchm
arking P
rog
ress
EX
PE
RIE
NC
E E
XC
HA
NG
ED
ata Integ
rity Mo
ck Insp
ection —
Mitig
ating
Risk
Brin
g Y
ou
r Ow
n Ch
alleng
e (BY
OC
) Wo
rksho
p —
H
orro
r Ed
ition
Offi
ce Ho
urs —
An O
pp
ortu
nity to
Get Q
uestio
ns
An
swered
by E
xpert S
peakin
g F
aculty
PLUS!E
xtend Yo
ur Learning O
pp
ortunity to
Include a
One D
ay Training C
ourse
GM
P O
versight in the Q
C Lab
orato
ry Tuesd
ay, Decem
ber 3, 20
19T
his intensive, full-day co
urse uses real inspectio
n find
ings, w
arning letters,
48
3 and aud
it find
ings, to
identify C
ritical Co
ntrol P
oints in the lab
orato
ry. G
et a jump
start on Lab
Week!
R E G I S T E R AT W W W.C B I N E T.C O M / L A B W E E K • 8 0 0 - 8 1 7 - 8 6 0 1
ANY QUESTIONS OR TO REGISTER CONTACT:
John Schafer phone 339-298-2215 email john.schafer@cbinet.com
FD
A K
EY
NO
TE A
DD
RE
SST
he Reg
ulatory A
-Z o
f Analytical M
ethod
sSangeeta M
. Khurana, Ph.D., Interdisciplinary Scientist/Investigator
(GD
UFA), O
ffice of Pharm
aceutical Quality O
perations (OPQ
O) –
Division 4, O
ffice of M
edical Products and Tobacco Operations, O
RA,
U.S. Food and Drug Administration (FDA)