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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

Beth McCullough
Director, Quality and Risk Management
GlaxoSmithKline

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

Determine Lifecycle, Phase Appropriate Activities

I. The Lifecycle Approach

II. The Analytical Target Profile (ATP)

III. Phase Dependent Activities

Jerry Lanese, PhD
President
The Lanese Group, LLC

4:00

ENFORCEMENT UPDATE Industry Pulse on Emerging Regulatory Trends and Warning Letters —
FDA, MHRA, USP and Beyond

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

5:00

Close of Day One

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

DAY TWO TUESDAY, DECEMBER 5, 2017

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Validation projects can be complicated, but are you making the job more difficult by continuing to use outdated documentation standards?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

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

SESSION 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 Validation and Development of Analytical Master Validation Plan

III. Validation Protocol And Experimental Design

IV. Analytical Method Transfers, BLA Authoring and Global Filings

V. Interactive Exercise

Jason Starkey, PhD
Senior Director, Analytical Research and Development,
BioTherapeutics Pharmaceutical Sciences
Pfizer Inc

SESSION 2 Using Design of Experiments to Speed Up
Method Development and Validation

I. A Look at Today’s Realities

II. How to Use Statistical Design of Experiments in Method Validation

III. How to Troubleshoot Measurement Methods

Ronald D. Snee, PhD
President
Snee Associates LLC

12:00

Networking Luncheon

1:00 – 2:30

90-MINUTE WORKSHOP

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

During this unique workshop, validation, QA/QC and science professionals from pharmaceutical, biotech and medical device companies share their greatest pain points and then collaborate with their method 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.

Lina Patel, PhD
Director, Quality Operations Bio-Analytical Laboratory
Merck Manufacturing Division

2:30

Office Hours & Networking and Refreshment Break

3:00 – 4:30

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

SESSION 3 Total Error in Validation, Transfer and
Method Comparison — Concept and Advantages

I. ICH Q2, USP 1230 and Total Error

II. Applications in Method Validation, Transfer and Comparison

III. Link to Process Development and Product Understanding

Perceval Sondag
Senior Manager, Statistics
PharmaLex Development Services

SESSION 4 Continuous Performance Verification Programs for Analytical Methods as Part of Lifecycle Management

I. Analytical Lifecycle Principles

II. Expectations Include Quality Systems/Programs

III. How to Perform Risk-Based Evaluations Based on Intended Use, Method Type and Complexity

IV. Interactive Activity

Debora Aguiar
Director, Quality Control Technical Services
Genzyme

4:30

Close of Day Two

DAY THREE WEDNESDAY, DECEMBER 6, 2017

7:30

INTERACTIVE EYE-OPENER BREAKFAST DISCUSSION Analytical Quality by Design

Jane Weitzel, BSc Honors
Independent Consultant

8:30 – 10:00

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

SESSION 5 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 6 Analytical Scientists in Pharmaceutical
Over-the-Counter Product Development

I. Must-Have Scientific Skills

II. Soft Skills for Career Advancement

III. Interactive Exercise

Kangping Xiao, PhD
Director, Global Innovation and Development Center – Analytical Development
Bayer Consumer Health

10:00

Office Hours & Networking and Refreshment Break

10:30 – 12:00

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

SESSION 7A Systems Approach to Root Cause Analysis
and CAPA Investigations

I. Today’s Realities

II. Systematic Approach — Roadmap and Tools

III. Solving System Failure Problems

IV. Sustaining the Elimination of Root Causes

Ronald D. Snee, PhD
President
Snee Associates LLC

SESSION 8 Work an Example from Beginning to End for
the Lifecycle of an Analytical Procedure
Using Analytical Quality by Design

During this session, apply all you have learned during the conference by working through an example based on a USP monograph procedure. The goal of this workshop is to develop a risk analysis, set acceptance criteria for the analytical procedure qualification experiments, design the control strategy and monitor the procedure during continued verification.

Interactive Exercise

Ronald D. Snee PhD
President
Snee Associates LLC

12:00

Networking Luncheon

1:00 – 2:30

CHOOSE BETWEEN TWO 90-MINUTE SESSIONS (9-10)

SESSION 9 Implement and Optimize an Effective
Method Transfer Strategy

I. Method Transfer Procedure

II. Options of Method Transfer Case Study

III. Lab Deviations During Method Transfer

IV. Interactive Exercise

Andy Wang, PhD
Principal Scientist, Analytical Development
Janssen Pharm, Johnson & Johnson

SESSION 10 Establish Acceptance Criteria for
Analytical Methods

I. What are Acceptance Criteria?

II. The Impact of the Test Method on the Acceptance Criteria

III. How is the Industry Handling Acceptance Criteria?

Jerry Lanese, PhD
President
The Lanese Group, LLC

3:00 – 4:00

60-MINUTE SESSION

Understanding the Role of System Suitability and Determining Appropriate Criteria

I. Difference between System Suitability and Method Suitability

II. How to Understand Your Method Performance During Development — Use of an SPC Chart

III. Interactive Exercise

David Kesselring, PhD
Principal Analytical Chemist
Mallinckrodt Pharmaceuticals

4:00

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

Beth McCullough
Director, Quality and Risk Management
GlaxoSmithKline

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

Determine Lifecycle, Phase Appropriate Activities

I. The Lifecycle Approach

II. The Analytical Target Profile (ATP)

III. Phase Dependent Activities

Jerry Lanese, PhD
President
The Lanese Group, LLC

4:00

ENFORCEMENT UPDATE Industry Pulse on Emerging Regulatory Trends and Warning Letters —
FDA, MHRA, USP and Beyond

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

5:00

Close of Day One

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

DAY TWO TUESDAY, DECEMBER 5, 2017

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

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

SESSION 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 Validation and Development of Analytical Master Validation Plan

III. Validation Protocol And Experimental Design

IV. Analytical Method Transfers, BLA Authoring and Global Filings

V. Interactive Exercise

Jason Starkey, PhD
Senior Director, Analytical Research and Development,
BioTherapeutics Pharmaceutical Sciences
Pfizer Inc

SESSION 2 Using Design of Experiments to Speed Up
Method Development and Validation

I. A Look at Today’s Realities

II. How to Use Statistical Design of Experiments in Method Validation

III. How to Troubleshoot Measurement Methods

Ronald D. Snee, PhD
President
Snee Associates LLC

12:00

Networking Luncheon

1:00 – 2:30

90-MINUTE WORKSHOP

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

During this unique workshop, validation, QA/QC and science professionals from pharmaceutical, biotech and medical device companies share their greatest pain points and then collaborate with their method 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.

Lina Patel, PhD
Director, Quality Operations Bio-Analytical Laboratory
Merck Manufacturing Division

2:30

Office Hours & Networking and Refreshment Break

3:00 – 4:30

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

SESSION 3 Total Error in Validation, Transfer and
Method Comparison — Concept and Advantages

I. ICH Q2, USP 1230 and Total Error

II. Applications in Method Validation, Transfer and Comparison

III. Link to Process Development and Product Understanding

Perceval Sondag
Senior Manager, Statistics
PharmaLex Development Services

SESSION 4 Continuous Performance Verification Programs for Analytical Methods as Part of Lifecycle Management

I. Analytical Lifecycle Principles

II. Expectations Include Quality Systems/Programs

III. How to Perform Risk-Based Evaluations Based on Intended Use, Method Type and Complexity

IV. Interactive Activity

Debora Aguiar
Director, Quality Control Technical Services
Genzyme

4:30

Close of Day Two

DAY THREE WEDNESDAY, DECEMBER 6, 2017

7:30

INTERACTIVE EYE-OPENER BREAKFAST DISCUSSION Analytical Quality by Design

Jane Weitzel, BSc Honors
Independent Consultant

8:30 – 10:00

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

SESSION 5 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 6 Analytical Scientists in Pharmaceutical
Over-the-Counter Product Development

I. Must-Have Scientific Skills

II. Soft Skills for Career Advancement

III. Interactive Exercise

Kangping Xiao, PhD
Director, Global Innovation and Development Center – Analytical Development
Bayer Consumer Health

10:00

Office Hours & Networking and Refreshment Break

10:30 – 12:00

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

SESSION 7A Systems Approach to Root Cause Analysis
and CAPA Investigations

I. Today’s Realities

II. Systematic Approach — Roadmap and Tools

III. Solving System Failure Problems

IV. Sustaining the Elimination of Root Causes

Ronald D. Snee, PhD
President
Snee Associates LLC

SESSION 8 Work an Example from Beginning to End for
the Lifecycle of an Analytical Procedure
Using Analytical Quality by Design

During this session, apply all you have learned during the conference by working through an example based on a USP monograph procedure. The goal of this workshop is to develop a risk analysis, set acceptance criteria for the analytical procedure qualification experiments, design the control strategy and monitor the procedure during continued verification.

Interactive Exercise

Ronald D. Snee PhD
President
Snee Associates LLC

12:00

Networking Luncheon

1:00 – 2:30

CHOOSE BETWEEN TWO 90-MINUTE SESSIONS (9-10)

SESSION 9 Implement and Optimize an Effective
Method Transfer Strategy

I. Method Transfer Procedure

II. Options of Method Transfer Case Study

III. Lab Deviations During Method Transfer

IV. Interactive Exercise

Andy Wang, PhD
Principal Scientist, Analytical Development
Janssen Pharm, Johnson & Johnson

SESSION 10 Establish Acceptance Criteria for
Analytical Methods

I. What are Acceptance Criteria?

II. The Impact of the Test Method on the Acceptance Criteria

III. How is the Industry Handling Acceptance Criteria?

Jerry Lanese, PhD
President
The Lanese Group, LLC

3:00 – 4:00

60-MINUTE SESSION

Understanding the Role of System Suitability and Determining Appropriate Criteria

I. Difference between System Suitability and Method Suitability

II. How to Understand Your Method Performance During Development — Use of an SPC Chart

III. Interactive Exercise

David Kesselring, PhD
Principal Analytical Chemist
Mallinckrodt Pharmaceuticals

4:00

Close of Conference