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Agenda

Data Integrity • Method Transfers and Validation • Stability Testing

December 4-6, 2019
  • Philadelphia, PA

Agenda

Want more agenda details? Download the brochure.

DAY ONE WEDNESDAY, DECEMBER 4, 2019

7:30

Registration and Continental Breakfast

8:30

CHOOSE BETWEEN TWO MORNING SUMMITS (1-2)

SUMMIT 1 | Statistics in Validation —
Focused Tools for the Practical Lab

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-Statisticians

I. Introduction

II. The Concept of Variance (and Why It Is Important)

III. Expressing Variance

IV. Process Capability

PART 2 — Validation Sampling Plans and
Setting Acceptance Criteria for Process and Test Method Validation

I. What Is Sampling?

II. Validation Sampling

III. Setting up a Validation Sampling Plan

IV. Using Sampling Plans to Set Acceptance Criteria for
Process Validation

V. The Concept of Acceptance Criteria in Test Method Validation

VI. Use of Process Capability

VII. Statistical Process Controls

Alan Golden
Principal, Design Quality Consultants, LLC;
former Principal Quality Professional, Abbott Molecular

*There will be a 30-minute networking and refreshment break at 10:00am

SUMMIT 2 | Pharmaceutical Stability Discussion Group (PSDG) Sampler —
Stability Assessment and Benchmarking Progress

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

*There will be a 30-minute networking and refreshment break at 10:00am

12:00

Networking Luncheon

1:00

Chairperson’s Welcome and Opening Remarks

Shilpi Guliani
Associate Director, IT Quality Engineering
Gilead Sciences

1:30

FDA KEYNOTE ADDRESS
The Regulatory A-Z of Analytical Methods

I. Updated Guidance

II. Regulatory Expectations

III. Designing an Analytical Procedure for Data Governance

IV. Audit Trail Hotspots and Compliance Breakdown

Sangeeta M. Khurana, PhD
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

2:00

Smart Innovation; Intelligent Labs —
Key Points to Consider in the Lab of the Future

Shilpi 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.

Wednesday, Dec. 4 – 3:00PM Office Hours
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)

Thursday, Dec. 5 – 2:30PM Office Hours
Rick Meyer
President
Superior Laboratory Services, Inc.

Friday, Dec. 6 – 10:00 AM Office Hours
Emily Trubee
Stability Manager, R&D
ADARE Pharmaceuticals

3:30

Paperless Lab, Electronic Lab Notes (ELN) and Big Data — Digitization

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 TWO THURSDAY, DECEMBER 5, 2019

8:00

Continental Breakfast

8:30

CHOOSE BETWEEN TWO CONFERENCE TRACKS (1-2)

METHOD TRANSFERS & VALIDATION 1 A Two-Part Method Transfer and
Validation Perspective

Part 1 — Validation and Transfer of Analytical Methods for Biologics to Enable Commercial Launch

I. Pre-Validation Activities and Method Assessments

II. Background of Biologic Process Performance Qualification and Development of Analytical Master Validation Plan

III. Validation Protocol, Experimental Design and Validation Report

IV. Life Cycle Management, BLA Authoring, and Global Filings

Balaji Viswanathan, PhD
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 Assessment

I. Statistical Assessment for Method Transfer

II. Acceptance Criteria Setting Based on the Method Precision

III. Practical Statistical Strategies for Different Method Transfer Situations

Aili 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-life

Maria Krisch, PhD
Senior Scientist
FreeThink Technologies, Inc.

10:00

Networking and Refreshment Break

10:30

CHOOSE BETWEEN TWO CONFERENCE TRACKS (3-4)

METHOD TRANSFERS & VALIDATION 3 Measuring Risk with Systems Capabilities — Equipment Failures, Compliance Workarounds and Out-of-the-Box Solutions

Karen 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

1:00

CHOOSE BETWEEN TWO CONFERENCE TRACKS (5-6)

METHOD TRANSFERS & VALIDATION 5 Risk-Based Continued Test Method
Performance Verification

Ronald D. Snee, PhD
President, Consultant
Snee Associates, LLC

STABILITY TESTING 6 Stability Studies Design —
Support for Early Clinical Development

Geoff Carr
Director of Analytical Development, Ontario
Patheon by ThermoFisher Scientific

1:00

CHOOSE FROM THREE CONFERENCE TRACKS (7-9)

METHOD TRANSFERS & VALIDATION 7 Preparing for FDA Audits and Inspections

Focusing 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.

Ronald D. Snee, PhD
President, Consultant
Snee Associates, LLC

DATA INTEGRITY 8 Risk Management for Computerized Systems

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 Maintenance

Abhishek Bachchan
Senior Manager, Global IT Compliance
ThermoFisher Scientific

STABILITY TESTING 9 From R&D to Commercialization —
Implementing GMP-Level Standards Early for More Efficient Product Transitions

Emily Trubee
Stability Manager, R&D
ADARE Pharmaceuticals

2:30

Networking and Refreshment Break

3:00

Data Integrity Mock Inspection — Mitigating Risk

FACILITATOR/MOCK INSPECTOR:

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

8:30

Bring Your Own Challenge (BYOC) Workshop — Horror Edition

John O’Neill, MS, RPh
Stability Information Specialist
StabilityHub

Geoff Carr
Director of Analytical Development, Ontario
Patheon by Thermo Fisher Scientific

10:00

Networking and Refreshment Break

Office Hours Meet one-on-one with speakers to discuss your unique laboratory challenges.

10:30

CHOOSE FROM THREE CONFERENCE TRACKS (10-12)

METHOD TRANSFERS & VALIDATION 10 Quality by Design (QbD) Mindset for
Method Transfer and Qualification

Design 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.

Jane Weitzel, MS
Independent Consultant

DATA INTEGRITY 11 Building a Lab to Be FDA Inspection-Ready
in One Year

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.

Libby Russell
Senior Vice President
Neva Analytics

STABILITY TESTING 12 Preparing for Audits and Inspections of
the Stability Program

Emily Trubee
Stability Manager, R&D
ADARE Pharmaceuticals

12:00

Networking Luncheon

1:00

CHOOSE BETWEEN TWO CONFERENCE TRACKS (13-14)

METHOD TRANSFERS & VALIDATION 13 Balancing Regulatory Requirements and
Business Criticalities

Companies 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

II. Regulatory Compliance — Where Does It Apply?

III. Challenges for Regulatory Compliance

IV. Impact of Non-Compliance to Regulatory Requirements

V. Initiatives and Required Competencies that Companies Must Excel at to Be Successful Due to On-Going Changes in Regulatory Requirements

Ben Zarza
Site Validation Manager
ThermoFisher Scientific

STABILITY TESTING 14 Forced Degradation Studies —
Applying Good Science and Regulatory Guidelines to Maximize Efficiency

Geoff Carr
Director of Analytical Development, Ontario
Patheon by ThermoFisher Scientific

2:00

Close of Conference

Agenda

Want more agenda details? Download the brochure.

Want more agenda details? Download the brochure.

DAY ONE WEDNESDAY, DECEMBER 4, 2019

7:30

Registration and Continental Breakfast

8:30

CHOOSE BETWEEN TWO MORNING SUMMITS (1-2)

SUMMIT 1 | Statistics in Validation —
Focused Tools for the Practical Lab

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-Statisticians

I. Introduction

II. The Concept of Variance (and Why It Is Important)

III. Expressing Variance

IV. Process Capability

PART 2 — Validation Sampling Plans and
Setting Acceptance Criteria for Process and Test Method Validation

I. What Is Sampling?

II. Validation Sampling

III. Setting up a Validation Sampling Plan

IV. Using Sampling Plans to Set Acceptance Criteria for
Process Validation

V. The Concept of Acceptance Criteria in Test Method Validation

VI. Use of Process Capability

VII. Statistical Process Controls

Alan Golden
Principal, Design Quality Consultants, LLC;
former Principal Quality Professional, Abbott Molecular

*There will be a 30-minute networking and refreshment break at 10:00am

SUMMIT 2 | Pharmaceutical Stability Discussion Group (PSDG) Sampler —
Stability Assessment and Benchmarking Progress

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

*There will be a 30-minute networking and refreshment break at 10:00am

12:00

Networking Luncheon

1:00

Chairperson’s Welcome and Opening Remarks

Shilpi Guliani
Associate Director, IT Quality Engineering
Gilead Sciences

1:30

FDA KEYNOTE ADDRESS
The Regulatory A-Z of Analytical Methods

I. Updated Guidance

II. Regulatory Expectations

III. Designing an Analytical Procedure for Data Governance

IV. Audit Trail Hotspots and Compliance Breakdown

Sangeeta M. Khurana, PhD
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

2:00

Smart Innovation; Intelligent Labs —
Key Points to Consider in the Lab of the Future

Shilpi 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.

Wednesday, Dec. 4 – 3:00PM Office Hours
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)

Thursday, Dec. 5 – 2:30PM Office Hours
Rick Meyer
President
Superior Laboratory Services, Inc.

Friday, Dec. 6 – 10:00 AM Office Hours
Emily Trubee
Stability Manager, R&D
ADARE Pharmaceuticals

3:30

Paperless Lab, Electronic Lab Notes (ELN) and Big Data — Digitization

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 TWO THURSDAY, DECEMBER 5, 2019

8:00

Continental Breakfast

8:30

CHOOSE BETWEEN TWO CONFERENCE TRACKS (1-2)

METHOD TRANSFERS & VALIDATION 1 A Two-Part Method Transfer and
Validation Perspective

Part 1 — Validation and Transfer of Analytical Methods for Biologics to Enable Commercial Launch

I. Pre-Validation Activities and Method Assessments

II. Background of Biologic Process Performance Qualification and Development of Analytical Master Validation Plan

III. Validation Protocol, Experimental Design and Validation Report

IV. Life Cycle Management, BLA Authoring, and Global Filings

Balaji Viswanathan, PhD
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 Assessment

I. Statistical Assessment for Method Transfer

II. Acceptance Criteria Setting Based on the Method Precision

III. Practical Statistical Strategies for Different Method Transfer Situations

Aili 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-life

Maria Krisch, PhD
Senior Scientist
FreeThink Technologies, Inc.

10:00

Networking and Refreshment Break

10:30

CHOOSE BETWEEN TWO CONFERENCE TRACKS (3-4)

METHOD TRANSFERS & VALIDATION 3 Measuring Risk with Systems Capabilities — Equipment Failures, Compliance Workarounds and Out-of-the-Box Solutions

Karen 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

1:00

CHOOSE BETWEEN TWO CONFERENCE TRACKS (5-6)

METHOD TRANSFERS & VALIDATION 5 Risk-Based Continued Test Method
Performance Verification

Ronald D. Snee, PhD
President, Consultant
Snee Associates, LLC

STABILITY TESTING 6 Stability Studies Design —
Support for Early Clinical Development

Geoff Carr
Director of Analytical Development, Ontario
Patheon by ThermoFisher Scientific

1:00

CHOOSE FROM THREE CONFERENCE TRACKS (7-9)

METHOD TRANSFERS & VALIDATION 7 Preparing for FDA Audits and Inspections

Focusing 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.

Ronald D. Snee, PhD
President, Consultant
Snee Associates, LLC

DATA INTEGRITY 8 Risk Management for Computerized Systems

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 Maintenance

Abhishek Bachchan
Senior Manager, Global IT Compliance
ThermoFisher Scientific

STABILITY TESTING 9 From R&D to Commercialization —
Implementing GMP-Level Standards Early for More Efficient Product Transitions

Emily Trubee
Stability Manager, R&D
ADARE Pharmaceuticals

2:30

Networking and Refreshment Break

3:00

Data Integrity Mock Inspection — Mitigating Risk

FACILITATOR/MOCK INSPECTOR:

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

8:30

Bring Your Own Challenge (BYOC) Workshop — Horror Edition

John O’Neill, MS, RPh
Stability Information Specialist
StabilityHub

Geoff Carr
Director of Analytical Development, Ontario
Patheon by Thermo Fisher Scientific

10:00

Networking and Refreshment Break

Office Hours Meet one-on-one with speakers to discuss your unique laboratory challenges.

10:30

CHOOSE FROM THREE CONFERENCE TRACKS (10-12)

METHOD TRANSFERS & VALIDATION 10 Quality by Design (QbD) Mindset for
Method Transfer and Qualification

Design 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.

Jane Weitzel, MS
Independent Consultant

DATA INTEGRITY 11 Building a Lab to Be FDA Inspection-Ready
in One Year

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.

Libby Russell
Senior Vice President
Neva Analytics

STABILITY TESTING 12 Preparing for Audits and Inspections of
the Stability Program

Emily Trubee
Stability Manager, R&D
ADARE Pharmaceuticals

12:00

Networking Luncheon

1:00

CHOOSE BETWEEN TWO CONFERENCE TRACKS (13-14)

METHOD TRANSFERS & VALIDATION 13 Balancing Regulatory Requirements and
Business Criticalities

Companies 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

II. Regulatory Compliance — Where Does It Apply?

III. Challenges for Regulatory Compliance

IV. Impact of Non-Compliance to Regulatory Requirements

V. Initiatives and Required Competencies that Companies Must Excel at to Be Successful Due to On-Going Changes in Regulatory Requirements

Ben Zarza
Site Validation Manager
ThermoFisher Scientific

STABILITY TESTING 14 Forced Degradation Studies —
Applying Good Science and Regulatory Guidelines to Maximize Efficiency

Geoff Carr
Director of Analytical Development, Ontario
Patheon by ThermoFisher Scientific

2:00

Close of Conference