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DAY ONE MONDAY, DECEMBER 4, 2017

7:30

Pre-Conference Registration and Continental Breakfast

8:30 – 12:00

CHOOSE BETWEEN TWO PRE-CONFERENCE WORKSHOPS (A-B)

WORKSHOP A Mitigating Data Integrity Risk in Analytical Methods and Stability Testing

I. Laboratory Data Integrity Issues Found in Audits and Inspections

II. Implement Electronic Controls around Data Integrity

III. Interactive Exercise

Chris Wubbolt, BS
Principal Consultant
QACV Consulting, LLC

 
WORKSHOP B Lifecycle Management in the Laboratory

I. Regulations, Requirements, Guidelines, Standards and Expectations

II. Lifecycle Management in the Laboratory

III. Use of Risk Management in Analytical Lifecycle

IV. Interactive Exercise

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

There will be a Networking and Refreshment Break at 10:00am

MAIN CONFERENCE MONDAY, DECEMBER 4, 2017

12:00

Conference Registration

1:00

Chairperson’s Welcome and Opening Remarks

Eugene Herron
Quality Stability Specialist, Quality Assurance
Noven Pharmaceuticals

1:15

REGULATORY SNAPSHOT Regulatory Guidances in Analytical Methods, Stability Testing and Lifecycle Laboratory Management

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

2:45

Office Hours & Networking and Refreshment Break

3:15 – 4:45

90-MINUTE SESSION

Risky Business — Exploring the Importance of Applying Risk Assessment to Stability Functions

I. Discover Why Risk Assessment is Important and Value Added

II. Learn How Risk is Identified, Evaluated and Weighted

III. List the Centers of Risk Lurking within the Stability Program

IV. Interactive Exercise

IV. Mitigate Stability Risk — Explore Strategies and Resources

John O’Neill, PhD
Stability Information Specialist
Nagano Science USA

4:45

Close of Day One

Networking, Wine and Cheese Reception (immediately following the close of day one)

DAY TWO TUESDAY, DECEMBER 5, 2017

7:30

Eye-Opener Breakfast Discussion Analyze Approaches to Create Stability OOT Limits

Eugene Herron
Quality Stability Specialist, Quality Assurance
Noven Pharmaceuticals

8:30 – 10:00

90-MINUTE SESSION

Writing Master Validation Plans

Validation projects can be complicated, but are you making the job more difficult by continuing to use outdated documentation standards? This session dives into the best practices for documentation that can be easily understood, approved and executed while enhancing the auditability of the package for regulatory review. We look at every task and deliverable to help you find ways to improve areas such as training, requirements definition, communication, execution and deviation resolution.

Ty Mew
President
Ofni Systems

10:00

Office Hours & Networking and Refreshment Break

10:30 – 12:00

90-MINUTE WORKSHOP

BYOC — BRING YOUR OWN CHALLENGE Practical Applications for Critical Method Validation Procedures

During this unique workshop, validation, QA/QC and stability professionals from pharmaceutical, biotech and medical device companies share their greatest pain points and then collaborate with their stability counterparts to develop strategies for managing their most pressing challenges. The content for the workshop is driven by the participants, who are surveyed ahead of time about the topics they wish to discuss.

John O’Neill, PhD
Stability Information Specialist
Nagano Science USA

12:00

Networking Luncheon

1:00 – 2:30

CHOOSE BETWEEN TWO 90-MINUTE SESSIONS (1-2)

SESSION 1 Conducting Excipient Compatibility Studies (ECS)

I. Pros and Cons of Excipients and Why ECS Studies Are Important

II. Types of ECS Study Designs

III. Practical Considerations for Preparing and Testing ECS Study Samples

IV. Case Study Example

V. Interactive Exercise

Geoff Carr, PhD
Director, Analytical Development
Patheon Inc, Canada

SESSION 2Investigate OOT and OOS in Stability Studies

I. Identification of OOT Results

II. Identify OOS Results

III. Confirm OOS Results

IV. Interactive Exercise

Sarah Christie
Director of Quality
Product Quest Manufacturing LLC

2:30

Office Hours & Networking and Refreshment Break

3:00 – 4:30

90-MINUTE SESSION

User Requirements and Implementation of a Risk-Based, Compliant Stability Management System Aligned with
FDA’s New Data Integrity Draft Guidance

Parsa Famili
President & CEO
Novatek International

4:30

Close of Day Two

DAY THREE WEDNESDAY, DECEMBER 6, 2017

7:30

Continental Breakfast

8:30 – 10:00

CHOOSE BETWEEN TWO 90-MINUTE SESSIONS (3-4)

SESSION 3 LIVE DATA CAPTURE Senior-Level Think Tank — Analytical Integrity

This session is owned by the delegates. It is intended for personnel with a minimum of ten years’ experience in industry and is an opportunity to exchange views, benchmark and share best practices with other professionals. Key learnings are captured live and then sent out to participants.

The think tank is focused on ways in which companies are strengthening their overall analytical integrity, through discussion of the four requisites for data integrity in the QC laboratory.

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

SESSION 4 Evaluation of Stability — A Statistical Perspective

I. Modelling of Stability Experiments

II. In-Use Stability Testing

III. Accelerated Stability Modeling and Shelf-Life Estimation

IV. Interactive Exercise

Robert Magari, PhD
Global Director, Biostatistics and Data Management
Beckman Coulter

10:00

Office Hours & Networking and Refreshment Break

10:30 – 12:00

CHOOSE BETWEEN TWO 90-MINUTE SESSIONS (5-6)

SESSION 5 Theory and Practical Design of Forced
Degradation Studies

I. Pharmaceutical Degradation Chemistry

II. Regulatory Requirements

III. Practical Applications

IV. Interactive Exercise

Geoff Carr, PhD
Director, Analytical Development
Patheon Inc, Canada

SESSION 6 Stability Studies Not Covered by ICH

I. Regulatory Expectations on Stability Studies

II. Stability Studies to Support Excursions through Distribution and Global Supply Chain

III. Interactive Discussion

IV. Stability Studies to Support OTC Products

V. Interactive Discussion

Ronald D. SneePhD
President
Snee Associates LLC

12:00

Networking Luncheon

1:00 – 2:30

90-MINUTE SESSION

Special Applications of Accelerated Stability Modeling for
Drug Products — Excursions, In-Use Applications and
Tablet Dissolution

I. Building a Stability Model for a Drug Product

II. Excursions

III. In-Use Stability

IV. Tablet Dissolution

Kenneth C. Waterman, PhD
President
FreeThink Technologies, Inc.

2:30

Office Hours & Networking and Refreshment Break

3:00 – 4:30

CHOOSE BETWEEN TWO 90-MINUTE SESSIONS (7-8)

SESSION 7 Incorporate an Effective Change Management Process in Stability Programs

I. Manage Changes as Part of Quality Systems

II. Elements of a Change Control Process

III. Different Types of Changes Affecting Stability Profile

IV. Interactive Discussion

Kim Huynh-Ba, PhD
Executive Director, Pharmalytik;
Editor of the “Handbook of Stability Testing for Pharmaceutical Products: Regulations, Methodologies and Best Practices"

SESSION 8 How to Handle Stability Chamber Excursions

I. Define Chamber Excursions and Exemptions

II. Capture and Quantify Excursions

III. Respond to an Excursion with Containment, Remediation and Assessment of Impact on Product

IV. Interactive Exercise

John O’Neill
Stability Information Specialist
Nagano Science USA

4:30

Close of Conference

Want more agenda details? Download the brochure.

DAY ONE MONDAY, DECEMBER 4, 2017

7:30

Pre-Conference Registration and Continental Breakfast

8:30 – 12:00

CHOOSE BETWEEN TWO PRE-CONFERENCE WORKSHOPS (A-B)

WORKSHOP A Mitigating Data Integrity Risk in Analytical Methods and Stability Testing

I. Laboratory Data Integrity Issues Found in Audits and Inspections

II. Implement Electronic Controls around Data Integrity

III. Interactive Exercise

Chris Wubbolt, BS
Principal Consultant
QACV Consulting, LLC

 
WORKSHOP B Lifecycle Management in the Laboratory

I. Regulations, Requirements, Guidelines, Standards and Expectations

II. Lifecycle Management in the Laboratory

III. Use of Risk Management in Analytical Lifecycle

IV. Interactive Exercise

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

There will be a Networking and Refreshment Break at 10:00am

MAIN CONFERENCE MONDAY, DECEMBER 4, 2017

12:00

Conference Registration

1:00

Chairperson’s Welcome and Opening Remarks

Eugene Herron
Quality Stability Specialist, Quality Assurance
Noven Pharmaceuticals

1:15

REGULATORY SNAPSHOT Regulatory Guidances in Analytical Methods, Stability Testing and Lifecycle Laboratory Management

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

2:45

Office Hours & Networking and Refreshment Break

3:15 – 4:45

90-MINUTE SESSION

Risky Business — Exploring the Importance of Applying Risk Assessment to Stability Functions

I. Discover Why Risk Assessment is Important and Value Added

II. Learn How Risk is Identified, Evaluated and Weighted

III. List the Centers of Risk Lurking within the Stability Program

IV. Interactive Exercise

IV. Mitigate Stability Risk — Explore Strategies and Resources

John O’Neill, PhD
Stability Information Specialist
Nagano Science USA

4:45

Close of Day One

Networking, Wine and Cheese Reception (immediately following the close of day one)

DAY TWO TUESDAY, DECEMBER 5, 2017

7:30

Eye-Opener Breakfast Discussion Analyze Approaches to Create Stability OOT Limits

Eugene Herron
Quality Stability Specialist, Quality Assurance
Noven Pharmaceuticals

8:30 – 10:00

90-MINUTE SESSION

Writing Master Validation Plans

Validation projects can be complicated, but are you making the job more difficult by continuing to use outdated documentation standards? This session dives into the best practices for documentation that can be easily understood, approved and executed while enhancing the auditability of the package for regulatory review. We look at every task and deliverable to help you find ways to improve areas such as training, requirements definition, communication, execution and deviation resolution.

Ty Mew
President
Ofni Systems

10:00

Office Hours & Networking and Refreshment Break

10:30 – 12:00

90-MINUTE WORKSHOP

BYOC — BRING YOUR OWN CHALLENGE Practical Applications for Critical Method Validation Procedures

During this unique workshop, validation, QA/QC and stability professionals from pharmaceutical, biotech and medical device companies share their greatest pain points and then collaborate with their stability counterparts to develop strategies for managing their most pressing challenges. The content for the workshop is driven by the participants, who are surveyed ahead of time about the topics they wish to discuss.

John O’Neill, PhD
Stability Information Specialist
Nagano Science USA

12:00

Networking Luncheon

1:00 – 2:30

CHOOSE BETWEEN TWO 90-MINUTE SESSIONS (1-2)

SESSION 1 Conducting Excipient Compatibility Studies (ECS)

I. Pros and Cons of Excipients and Why ECS Studies Are Important

II. Types of ECS Study Designs

III. Practical Considerations for Preparing and Testing ECS Study Samples

IV. Case Study Example

V. Interactive Exercise

Geoff Carr, PhD
Director, Analytical Development
Patheon Inc, Canada

SESSION 2Investigate OOT and OOS in Stability Studies

I. Identification of OOT Results

II. Identify OOS Results

III. Confirm OOS Results

IV. Interactive Exercise

Sarah Christie
Director of Quality
Product Quest Manufacturing LLC

2:30

Office Hours & Networking and Refreshment Break

3:00 – 4:30

90-MINUTE SESSION

User Requirements and Implementation of a Risk-Based, Compliant Stability Management System Aligned with
FDA’s New Data Integrity Draft Guidance

Parsa Famili
President & CEO
Novatek International

4:30

Close of Day Two

DAY THREE WEDNESDAY, DECEMBER 6, 2017

7:30

Continental Breakfast

8:30 – 10:00

CHOOSE BETWEEN TWO 90-MINUTE SESSIONS (3-4)

SESSION 3 LIVE DATA CAPTURE Senior-Level Think Tank — Analytical Integrity

This session is owned by the delegates. It is intended for personnel with a minimum of ten years’ experience in industry and is an opportunity to exchange views, benchmark and share best practices with other professionals. Key learnings are captured live and then sent out to participants.

The think tank is focused on ways in which companies are strengthening their overall analytical integrity, through discussion of the four requisites for data integrity in the QC laboratory.

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

SESSION 4 Evaluation of Stability — A Statistical Perspective

I. Modelling of Stability Experiments

II. In-Use Stability Testing

III. Accelerated Stability Modeling and Shelf-Life Estimation

IV. Interactive Exercise

Robert Magari, PhD
Global Director, Biostatistics and Data Management
Beckman Coulter

10:00

Office Hours & Networking and Refreshment Break

10:30 – 12:00

CHOOSE BETWEEN TWO 90-MINUTE SESSIONS (5-6)

SESSION 5 Theory and Practical Design of Forced
Degradation Studies

I. Pharmaceutical Degradation Chemistry

II. Regulatory Requirements

III. Practical Applications

IV. Interactive Exercise

Geoff Carr, PhD
Director, Analytical Development
Patheon Inc, Canada

SESSION 6 Stability Studies Not Covered by ICH

I. Regulatory Expectations on Stability Studies

II. Stability Studies to Support Excursions through Distribution and Global Supply Chain

III. Interactive Discussion

IV. Stability Studies to Support OTC Products

V. Interactive Discussion

Ronald D. SneePhD
President
Snee Associates LLC

12:00

Networking Luncheon

1:00 – 2:30

90-MINUTE SESSION

Special Applications of Accelerated Stability Modeling for
Drug Products — Excursions, In-Use Applications and
Tablet Dissolution

I. Building a Stability Model for a Drug Product

II. Excursions

III. In-Use Stability

IV. Tablet Dissolution

Kenneth C. Waterman, PhD
President
FreeThink Technologies, Inc.

2:30

Office Hours & Networking and Refreshment Break

3:00 – 4:30

CHOOSE BETWEEN TWO 90-MINUTE SESSIONS (7-8)

SESSION 7 Incorporate an Effective Change Management Process in Stability Programs

I. Manage Changes as Part of Quality Systems

II. Elements of a Change Control Process

III. Different Types of Changes Affecting Stability Profile

IV. Interactive Discussion

Kim Huynh-Ba, PhD
Executive Director, Pharmalytik;
Editor of the “Handbook of Stability Testing for Pharmaceutical Products: Regulations, Methodologies and Best Practices"

SESSION 8 How to Handle Stability Chamber Excursions

I. Define Chamber Excursions and Exemptions

II. Capture and Quantify Excursions

III. Respond to an Excursion with Containment, Remediation and Assessment of Impact on Product

IV. Interactive Exercise

John O’Neill
Stability Information Specialist
Nagano Science USA

4:30

Close of Conference