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DAY ONE | WEDNESDAY, FEBRUARY 22, 2017

12:00

Main Conference Registration

1:00

Chairman’s Welcome and Opening Remarks

Parth Sampathkumar, PhD
Associate Director, Quality Control
Coherus Biosciences

1:10

Align and Understand FDA’s GMPs and ICH Q10 Pharmaceutical Quality System

David L. Chesney
Principal and General Manager, DL Chesney Consulting, LLC;
Former Director, U.S. Food and Drug Administration

1:50

Strategies to Revise Quality Policy and Quality Objectives

Eileen Cortes, EIT, MBA
QA Validation Manager, Quality Operations
Gilead Sciences

2:30

Define Risk and Risk Levels — Implement ICH Q9 Quality Risk Management

Gamal Amer, PhD
Principal
Premier Compliance Services, Inc.

3:10

Networking and Refreshment Break

3:40

Documentation Requirements and Strategies for the Pharmaceutical Quality System

Chris Wubbolt
Principal Consultant
QACV Consulting, LLC

4:20

Manage Product and Process Knowledge from Development through Commercial Life

Steven S. Kuwahara, PhD
Principal Consultant
GXP BioTechnology, LLC

5:00

Close of Day One

Networking Cocktail Reception (immediately following the close of day one)

DAY TWO | THURSDAY, FEBRUARY 23, 2017

7:00

Continental Breakfast

7:30

CHOOSE FROM TWO EYE-OPENER BREAKFAST SESSIONS (7-8)

Session 1 The Quick Guide to the Data Integrity and Quality Metric Guidances

Siegfried Schmitt, PhD
Principal Consultant
PAREXEL International

Session 2 SENIOR LEVEL THINK TANK Effective Management Strategies and Overcoming Challenges in Quality Management

Colette Jue
Senior Manager, Facilities Systems and Compliance
Genentech

8:30

CHOOSE FROM TWO INTERACTIVE WORKSHOPS (A-B)

WORKSHOP A Develop a Risk-Based, Data Integrity and Metrics-Driven Quality Management Program Enterprise-Wide

I. Let’s Talk About Quality — Seriously!

II. Risks, What Risks? Build Risk Management into the QMS without Getting Lost in the Detail

III. We All Love To Measure — Measure What? Rethinking Your Quality Metrics

IV. Interactive Exercise

Siegfried Schmitt, PhD
Principal Consultant
PAREXEL International

 
WORKSHOP B Implement an Effective Change Management System throughout GMP and Validation Environments

I. Change Management Principles

II. Change Management Process Flow and Change Control

III. Change Management Process — Atypical

Eileen Cortes, EIT, MBA
QA Validation Manager,
Quality Operations
Gilead Sciences

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

1:00

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

SESSION 3 Quality Metrics — The Journey to Excellence

I. FDA Quality Metrics Program

II. Quality Metrics Pilots and Quality Culture Approach

III. Metrics that Matter

IV. Interactive Exercise

Steve Greer
Corporate QA External Engagement Leader
Procter & Gamble

SESSION 4 Learn How to Perform a Risk-Based Impact Assessment — The Ground Rules and Major Areas of Consideration

I. Why Use A Risk-Based Approach?

II. What Are the Ground Rules?

III. How to Perform a Risk-Based Impact Assessment?

IV. Interactive Exercise

Jorge A. Cordero-Monroig, BSChE, MBA-GM
Validation and Metrology Lead
Bausch + Lomb

2:30

Networking and Refreshment Break

3:00

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

SESSION 5 Use Statistical Process Control (SPC) as a Tool for Understanding and Managing Variability

I. SPC — The Effective Control Strategy for an Analytical Procedure

II. The Use of Control Charts

III. Interactive Exercise

Jane Weitzel
Independent Consultant

SESSION 6 Conduct a Gap Analysis of Your Existing Change Control Program

I. Learn How to Conduct Gap Analysis and Know the Critical Areas of Consideration

II. How to Improve Your Existing Program

III. Interactive Exercise

Jorge A. Cordero-Monroig, BSChE, MBA-GM
Validation and Metrology Lead
Bausch + Lomb

4:30

Close of Day Two

DAY THREE | FRIDAY, FEBRUARY 24, 2017

7:15

Continental Breakfast

7:30

CHOOSE FROM TWO EYE-OPENER BREAKFAST SESSIONS (7-8)

SESSION 7 Process Quality Monitoring and Continual Process Improvement — Going from Good to Great!

I. Design with Quality in Mind

II. Learn How to Monitor Quality

III. Continuous Process Improvement

Kim Lim
CEO
Ultimate Labs

SESSION 8 SENIOR LEVEL THINK TANK Effective Management Strategies and Overcoming Challenges in Change Control

In this closed-door summit, senior-level QA/QC from pharmaceutical companies engage in open discussions with their colleagues about strategies for managing their most pressing challenges in change control and change management. The content for the summit is driven by the participants, who are surveyed ahead of time about the topics they wish to discuss.

Jill Neri
Quality Manager
Sanofi

8:30

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

SESSION 9 What to Do When Things Go Wrong — Apply Corrective Action (CAPA) Throughout the Product Life Cycle

I. When to Apply CAPA

II. Conduct an Early Risk Analysis and Refine It

III. Understand the Consequences of the CAPA

IV. Manage CAPAs as a Part of the Evolution of the Product

Steven S. Kuwahara, PhD
Principal Consultant
GXP BioTechnology, LLC

SESSION 10 Risk Management for Laboratory Operations and Stability Studies

I. Risk Management and the Analytical Procedure Life cycle

II. Know How to Assess the Risks

III. Interactive Exercise

Jane Weitzel
Independent Consultant

10:00

Networking and Refreshment Break

10:30

CHOOSE BETWEEN TWO 90-MINUTE SESSIONS (11-12)

SESSION 11 CASE STUDY Leadership to Improve Human Performance — The Hidden Return on Investment

I. ROI — Industry Case Study

II. 5 Keys to Improving Human Performance

III. Interactive Exercise

Steve Greer
Corporate QA External Engagement Leader
Procter & Gamble

SESSION 12 How to Successfully Prepare for and Host a Regulatory Inspection

I. The Purpose and Scope of Inspections

II. FDA Inspection Authority in the U.S. and Foreign Inspections

III. Key FDA Inspection References and What You Can Get From Them

IV. Important Site Logistics for Managing Inspections

V. The FDA-483

VI. What Causes FDA to Escalate Enforcement

David L. Chesney
Principal and General Manager, DL Chesney Consulting, LLC;
Former Director, U.S. Food and Drug Administration

12:00

Networking Luncheon

1:00

CHOOSE BETWEEN TWO 90-MINUTE SESSIONS (13-14)

SESSION 13 CASE STUDY Strategies for the Successful Implementation of Validation Lifecycle Management Systems

I. CASE STUDY Pharmaceutical/Biotechnology — Company System Owner Implementation

Ivan Soto
Director, Client Engagement & Product Strategy
ValGenesis Systems, System Owner Pharmaceutical Company

SESSION 14 Developing Evidence of Individual Responsibility — How FDA Determines Who to Hold Accountable for Violations

This presentation explains the importance FDA places on determining not just what went wrong, but why, and who may have been personally responsible for the issue. This aspect of FDA inspections, though considered critical by FDA, is often not well understood by companies undergoing inspections, and may lead to confusion and anxiety. Through this presentation, you will gain insight into how FDA goes about developing evidence of responsibility, information you can use in your inspection preparation efforts.

David L. Chesney
Principal and General Manager, DL Chesney Consulting, LLC;
Former Director, U.S. Food and Drug Administration

2:30

Networking and Refreshment Break

2:45

CHOOSE BETWEEN TWO 90-MINUTE SESSIONS (15-16)

SESSION 15 Ensure Data Integrity Compliance Enterprise-Wide

I. What is Data Integrity (DI) and the Definition of Data

II. Data Integrity Program Development

III. Audit Trail Review

Chris Wubbolt
Principal Consultant
QACV Consulting, LLC

SESSION 16 Supplier Qualification, Auditing and Quality Agreements — Effective Management of Outsourced Activities

I. Modern Outsourcing

II. An Approach to Identify the Need for Outside Service Providers

Gamal Amer, PhD
Principal
Premier Compliance Services, Inc.

4:15

Close of Conference

Want more agenda details? Download the brochure.

DAY ONE | WEDNESDAY, FEBRUARY 22, 2017

12:00

Main Conference Registration

1:00

Chairman’s Welcome and Opening Remarks

Parth Sampathkumar, PhD
Associate Director, Quality Control
Coherus Biosciences

1:10

Align and Understand FDA’s GMPs and ICH Q10 Pharmaceutical Quality System

David L. Chesney
Principal and General Manager, DL Chesney Consulting, LLC;
Former Director, U.S. Food and Drug Administration

1:50

Strategies to Revise Quality Policy and Quality Objectives

Eileen Cortes, EIT, MBA
QA Validation Manager, Quality Operations
Gilead Sciences

2:30

Define Risk and Risk Levels — Implement ICH Q9 Quality Risk Management

Gamal Amer, PhD
Principal
Premier Compliance Services, Inc.

3:10

Networking and Refreshment Break

3:40

Documentation Requirements and Strategies for the Pharmaceutical Quality System

Chris Wubbolt
Principal Consultant
QACV Consulting, LLC

4:20

Manage Product and Process Knowledge from Development through Commercial Life

Steven S. Kuwahara, PhD
Principal Consultant
GXP BioTechnology, LLC

5:00

Close of Day One

Networking Cocktail Reception (immediately following the close of day one)

DAY TWO | THURSDAY, FEBRUARY 23, 2017

7:00

Continental Breakfast

7:30

CHOOSE FROM TWO EYE-OPENER BREAKFAST SESSIONS (7-8)

Session 1 The Quick Guide to the Data Integrity and Quality Metric Guidances

Siegfried Schmitt, PhD
Principal Consultant
PAREXEL International

Session 2 SENIOR LEVEL THINK TANK Effective Management Strategies and Overcoming Challenges in Quality Management

Colette Jue
Senior Manager, Facilities Systems and Compliance
Genentech

8:30

CHOOSE FROM TWO INTERACTIVE WORKSHOPS (A-B)

WORKSHOP A Develop a Risk-Based, Data Integrity and Metrics-Driven Quality Management Program Enterprise-Wide

I. Let’s Talk About Quality — Seriously!

II. Risks, What Risks? Build Risk Management into the QMS without Getting Lost in the Detail

III. We All Love To Measure — Measure What? Rethinking Your Quality Metrics

IV. Interactive Exercise

Siegfried Schmitt, PhD
Principal Consultant
PAREXEL International

 
WORKSHOP B Implement an Effective Change Management System throughout GMP and Validation Environments

I. Change Management Principles

II. Change Management Process Flow and Change Control

III. Change Management Process — Atypical

Eileen Cortes, EIT, MBA
QA Validation Manager,
Quality Operations
Gilead Sciences

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

1:00

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

SESSION 3 Quality Metrics — The Journey to Excellence

I. FDA Quality Metrics Program

II. Quality Metrics Pilots and Quality Culture Approach

III. Metrics that Matter

IV. Interactive Exercise

Steve Greer
Corporate QA External Engagement Leader
Procter & Gamble

SESSION 4 Learn How to Perform a Risk-Based Impact Assessment — The Ground Rules and Major Areas of Consideration

I. Why Use A Risk-Based Approach?

II. What Are the Ground Rules?

III. How to Perform a Risk-Based Impact Assessment?

IV. Interactive Exercise

Jorge A. Cordero-Monroig, BSChE, MBA-GM
Validation and Metrology Lead
Bausch + Lomb

2:30

Networking and Refreshment Break

3:00

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

SESSION 5 Use Statistical Process Control (SPC) as a Tool for Understanding and Managing Variability

I. SPC — The Effective Control Strategy for an Analytical Procedure

II. The Use of Control Charts

III. Interactive Exercise

Jane Weitzel
Independent Consultant

SESSION 6 Conduct a Gap Analysis of Your Existing Change Control Program

I. Learn How to Conduct Gap Analysis and Know the Critical Areas of Consideration

II. How to Improve Your Existing Program

III. Interactive Exercise

Jorge A. Cordero-Monroig, BSChE, MBA-GM
Validation and Metrology Lead
Bausch + Lomb

4:30

Close of Day Two

DAY THREE | FRIDAY, FEBRUARY 24, 2017

7:15

Continental Breakfast

7:30

CHOOSE FROM TWO EYE-OPENER BREAKFAST SESSIONS (7-8)

SESSION 7 Process Quality Monitoring and Continual Process Improvement — Going from Good to Great!

I. Design with Quality in Mind

II. Learn How to Monitor Quality

III. Continuous Process Improvement

Kim Lim
CEO
Ultimate Labs

SESSION 8 SENIOR LEVEL THINK TANK Effective Management Strategies and Overcoming Challenges in Change Control

In this closed-door summit, senior-level QA/QC from pharmaceutical companies engage in open discussions with their colleagues about strategies for managing their most pressing challenges in change control and change management. The content for the summit is driven by the participants, who are surveyed ahead of time about the topics they wish to discuss.

Jill Neri
Quality Manager
Sanofi

8:30

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

SESSION 9 What to Do When Things Go Wrong — Apply Corrective Action (CAPA) Throughout the Product Life Cycle

I. When to Apply CAPA

II. Conduct an Early Risk Analysis and Refine It

III. Understand the Consequences of the CAPA

IV. Manage CAPAs as a Part of the Evolution of the Product

Steven S. Kuwahara, PhD
Principal Consultant
GXP BioTechnology, LLC

SESSION 10 Risk Management for Laboratory Operations and Stability Studies

I. Risk Management and the Analytical Procedure Life cycle

II. Know How to Assess the Risks

III. Interactive Exercise

Jane Weitzel
Independent Consultant

10:00

Networking and Refreshment Break

10:30

CHOOSE BETWEEN TWO 90-MINUTE SESSIONS (11-12)

SESSION 11 CASE STUDY Leadership to Improve Human Performance — The Hidden Return on Investment

I. ROI — Industry Case Study

II. 5 Keys to Improving Human Performance

III. Interactive Exercise

Steve Greer
Corporate QA External Engagement Leader
Procter & Gamble

SESSION 12 How to Successfully Prepare for and Host a Regulatory Inspection

I. The Purpose and Scope of Inspections

II. FDA Inspection Authority in the U.S. and Foreign Inspections

III. Key FDA Inspection References and What You Can Get From Them

IV. Important Site Logistics for Managing Inspections

V. The FDA-483

VI. What Causes FDA to Escalate Enforcement

David L. Chesney
Principal and General Manager, DL Chesney Consulting, LLC;
Former Director, U.S. Food and Drug Administration

12:00

Networking Luncheon

1:00

CHOOSE BETWEEN TWO 90-MINUTE SESSIONS (13-14)

SESSION 13 CASE STUDY Strategies for the Successful Implementation of Validation Lifecycle Management Systems

I. CASE STUDY Pharmaceutical/Biotechnology — Company System Owner Implementation

Ivan Soto
Director, Client Engagement & Product Strategy
ValGenesis Systems, System Owner Pharmaceutical Company

SESSION 14 Developing Evidence of Individual Responsibility — How FDA Determines Who to Hold Accountable for Violations

This presentation explains the importance FDA places on determining not just what went wrong, but why, and who may have been personally responsible for the issue. This aspect of FDA inspections, though considered critical by FDA, is often not well understood by companies undergoing inspections, and may lead to confusion and anxiety. Through this presentation, you will gain insight into how FDA goes about developing evidence of responsibility, information you can use in your inspection preparation efforts.

David L. Chesney
Principal and General Manager, DL Chesney Consulting, LLC;
Former Director, U.S. Food and Drug Administration

2:30

Networking and Refreshment Break

2:45

CHOOSE BETWEEN TWO 90-MINUTE SESSIONS (15-16)

SESSION 15 Ensure Data Integrity Compliance Enterprise-Wide

I. What is Data Integrity (DI) and the Definition of Data

II. Data Integrity Program Development

III. Audit Trail Review

Chris Wubbolt
Principal Consultant
QACV Consulting, LLC

SESSION 16 Supplier Qualification, Auditing and Quality Agreements — Effective Management of Outsourced Activities

I. Modern Outsourcing

II. An Approach to Identify the Need for Outside Service Providers

Gamal Amer, PhD
Principal
Premier Compliance Services, Inc.

4:15

Close of Conference