ivt network’sone day training course gmp oversight in the qc laboratory tuesday, december 3, 2019...

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

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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


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


AGENDA-AT-A-GLANCE


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


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



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


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


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


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



Measuring Risk with Systems Capabilities — Equipment Failures, Compliance Workarounds and Out-of-the-Box Solutions


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



Risk-Based Continued Test Method Performance Verification


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



Reading the FDA’s Mind — Preparing for FDA Audits and Inspections


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



Karen Ginsbury, BPharm, MSc, Founder and CEO, PCI Pharma Ltd.

DAY THREE FRIDAY, DECEMBER 6, 20191:00 CHOOSE FROM TWO CONFERENCE TRACKS (5-6)




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


Quality by Design (QbD) Mindset for Method Transfer and Qualification


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


Preparing for Audits and Inspections of the Stability Program

STABILITY TESTING

12





Balancing Regulatory Requirements and Business Criticalities


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


• 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 [email protected].

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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WEDNESDAY, DECEMBER 4, 20198:30 Summit Option 1 2

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4-6

, 2019

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ISTOR

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OR

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T NETW

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Data Integrity M

ethod Transfers and Validation Stability TestingD

EC

EM

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R 4-6, 2019 | W

YN

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PH

ILAD

ELP

HIA

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IST

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T | P

HILA

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LPH

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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

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riteria Setting

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ethod

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Lessons Learned

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tability F

unction

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indset fo

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sSangeeta M

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ffice of Pharm

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Division 4, O

ffice of M

edical Products and Tobacco Operations, O

RA,

U.S. Food and Drug Administration (FDA)

ivt network’sone day training course gmp oversight in the qc laboratory tuesday, december 3, 2019...

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