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Agenda

Implement Quality Metrics and Achieve Quality Systems Excellence

February 27-March 1, 2018
  • San Diego, CA

Agenda

Want more agenda details? Download the brochure.

DAY ONE| TUESDAY, FEBRUARY 27, 2018

12:00

Conference Registration

1:00

Chairperson’s Welcome and Opening Remarks

Alan Golden
Principal Quality Professional
Abbott Molecular

1:15

REGULATORY UPDATE FDA Quality Metrics Program — Where Does It Stand, What Have We Learned and Where is it Going?

Steven Greer
Corporate QA External Engagement Leader
The Procter & Gamble Company

2:00

Integrate Change Control and Risk Management into Manufacturing Controls, Validation and State of Control

Robert Lechton
Senior Manager, Engineering
Baxter International

Gordon Tommy, M.S., ASQ CQE, CMQ/OE
Change Control Management Element Owner
Baxter Healthcare

2:45

Networking and Refreshment Break
Office Hours — Meet one-on-one with speakers to solve your individual Quality and Change Control challenges.

3:15

Implement Quality Metrics — How to Identify Metrics that Are Leading (Not Lagging) and Actionable

Rod Freeman
Senior Staff Engineer, Global Quality Systems
Beckman Coulter

4:00

Performing an Impact Assessment to Support Quality Risk Management

Willis H. Thomas, Ph.D., PMP, CPT
Director, Training and Development
Akorn Pharmaceuticals

 

5:30

Close of Day One

IVT 2018 Kick-Off Party! Celebrate the start of IVT’s 2018 conference series with cocktails, snacks and games immediately after the close of day one

DAY TWO| WEDNESDAY, FEBRUARY 28, 2018

8:00

Continental Breakfast

8:30

Choose Between Two 90-Minute Sessions (1-2)

1Streamline Change Control and Risk Analysis to Support Lean Manufacturing and the Kaizen Process

I. How Does Lean Manufacturing Fit in the FDA-Regulated Industries?

II. How to Balance Lean Efforts and Stay Compliant

III. Interactive Exercise

Rod Freeman
Senior Staff Engineer, Global Quality Systems
Beckman Coulter

2Implement Risk Management into Change Control

I. What Is Risk Management?

II. Changes Driven by Risk

III. Risk Updates Driven by Change

IV.Implementation of Risk Management into the Process

V. Examples of FDA Warning Letters

Alan Golden
Principal Quality Professional
Abbott Molecular

10:00

Networking and Refreshment Break
Office Hours — Meet one-on-one with speakers to solve your individual Quality and Change Control challenges.

10:30

Choose Between Two 90-Minute Sessions (3-4)

3Leverage SPC as a Tool for Understanding and Managing Variability

I.What Is SPC?

II.Types of Processes

III.SPC as a Tool for Monitoring Process Stability

IV.Process Control Using SPC Data

Alan Golden
Principal Quality Professional
Abbott Molecular

4Key Elements to an Effective Global Change Control Strategy

I.Learn the Necessary Elements of a Global Change Control Strategy

II.Discuss How Change Control Supports Global Supply Chain Initiatives

III.Build Your Plan to Meet Compliance Requirements

Joe Goodman
Solutions Consulting Director
Sparta Systems

12:00

 

Networking Luncheon

1:00

Choose Between Two 90-Minute Sessions (5-6)

5Documentation — New Expectations Driven by the Pharmaceutical Quality System

I.ICH Q10 — The Pharmaceutical Quality System

II.ICH Q8 — Pharmaceutical Development

III.ICH Q9 — Quality Risk Management

IV.Process Validation Guidance

V.Quality Metrics

Jerry Lanese, Ph.D.
President
The Lanese Group, LLC

6Define Risk and Risk Levels – Implement ICH Q9 Quality Risk Management

I.Identify, Manage and Control Risk

II.Develop Quality Risk Management Process

III.Define System Boundaries

IV.Pitfall in QRM

V.Interactive Exercise

Amjad Ganma
Senior Quality Unit Manager
Tabuk Pharmaceutical Company

2:30

Networking and Refreshment Break
Office Hours — Meet one-on-one with speakers to solve your individual Quality and Change Control challenges.

3:00

BRING YOUR OWN CHALLENGE WORKSHOP

Practical Qualitative and Quantitative Approaches to Quality Risk Management

Willis H. Thomas, Ph.D., PMP, CPT
Director, Training and Development
Akorn Pharmaceuticals

4:30

Close of Day Two

DAY THREE| THURSDAY, MARCH 1, 2018

8:00

Continental Breakfast

8:30

One Size Does Not Fit All – Creating and Applying Custom Risk Management Tools

I.Explore Common Risk Tools

II.Understand When a Custom Risk Tool is Appropriate

III.Less-Formal Risk Tool Approaches

IV.Defining the “What”

V.Develop Ranking Criteria and Action Tables for a Custom Risk Tool

VI.Implement a Custom Risk Tool

VII.Interactive Exercise

Amanda B. McFarland
Senior Consultant
ValSource, LLC

There will be a 30-minute Networking and Refreshment Break at 10:00

12:00

Networking Luncheon

1:00

Choose Between Two 90-Minute Sessions (7-8)

7Explore Recent FDA Warning Letters and Industry Trends

I.Recent FDA Observations

II.FDA Enforcement Tools

III.Preventing Observations

IV.Cleaning Up After the Observation

Jerry Lanese, Ph.D.
President
The Lanese Group, LLC

8CASE STUDY | Supplier Qualification and Management

Aida Markham, CQE, CQA
Vice President, Compliance
QACV Consulting

2:30

Networking and Refreshment Break
Office Hours - Meet one-on-one with speakers to solve your individual Quality and Change Control challenges.

3:00

Choose Between Two 90-Minute Sessions (9-10)

9Senior-Level Think Tank — Strategies for the Advanced Quality Professional*

Parth Sampathkumar, PhD
Associate Director, Quality Control
Coherus Biosciences

10Assess the Robustness of a Quality Risk Management Program

I.Dive into QRM Technical Maturity

II.Understand and Evaluate QRM Cultural Maturity

III.Interactive Exercise

Amanda B. McFarland
Senior Consultant
ValSource, LLC

4:30

Close of Conference

Agenda

Want more agenda details? Download the brochure.
Want more agenda details? Download the brochure.

DAY ONE| TUESDAY, FEBRUARY 27, 2018

12:00

Conference Registration

1:00

Chairperson’s Welcome and Opening Remarks

Alan Golden
Principal Quality Professional
Abbott Molecular

1:15

REGULATORY UPDATE FDA Quality Metrics Program — Where Does It Stand, What Have We Learned and Where is it Going?

Steven Greer
Corporate QA External Engagement Leader
The Procter & Gamble Company

2:00

Integrate Change Control and Risk Management into Manufacturing Controls, Validation and State of Control

Robert Lechton
Senior Manager, Engineering
Baxter International

Gordon Tommy, M.S., ASQ CQE, CMQ/OE
Change Control Management Element Owner
Baxter Healthcare

2:45

Networking and Refreshment Break
Office Hours — Meet one-on-one with speakers to solve your individual Quality and Change Control challenges.

3:15

Implement Quality Metrics — How to Identify Metrics that Are Leading (Not Lagging) and Actionable

Rod Freeman
Senior Staff Engineer, Global Quality Systems
Beckman Coulter

4:00

Performing an Impact Assessment to Support Quality Risk Management

Willis H. Thomas, Ph.D., PMP, CPT
Director, Training and Development
Akorn Pharmaceuticals

 

5:30

Close of Day One

IVT 2018 Kick-Off Party! Celebrate the start of IVT’s 2018 conference series with cocktails, snacks and games immediately after the close of day one

DAY TWO| WEDNESDAY, FEBRUARY 28, 2018

8:00

Continental Breakfast

8:30

Choose Between Two 90-Minute Sessions (1-2)

1Streamline Change Control and Risk Analysis to Support Lean Manufacturing and the Kaizen Process

I. How Does Lean Manufacturing Fit in the FDA-Regulated Industries?

II. How to Balance Lean Efforts and Stay Compliant

III. Interactive Exercise

Rod Freeman
Senior Staff Engineer, Global Quality Systems
Beckman Coulter

2Implement Risk Management into Change Control

I. What Is Risk Management?

II. Changes Driven by Risk

III. Risk Updates Driven by Change

IV.Implementation of Risk Management into the Process

V. Examples of FDA Warning Letters

Alan Golden
Principal Quality Professional
Abbott Molecular

10:00

Networking and Refreshment Break
Office Hours — Meet one-on-one with speakers to solve your individual Quality and Change Control challenges.

10:30

Choose Between Two 90-Minute Sessions (3-4)

3Leverage SPC as a Tool for Understanding and Managing Variability

I.What Is SPC?

II.Types of Processes

III.SPC as a Tool for Monitoring Process Stability

IV.Process Control Using SPC Data

Alan Golden
Principal Quality Professional
Abbott Molecular

4Key Elements to an Effective Global Change Control Strategy

I.Learn the Necessary Elements of a Global Change Control Strategy

II.Discuss How Change Control Supports Global Supply Chain Initiatives

III.Build Your Plan to Meet Compliance Requirements

Joe Goodman
Solutions Consulting Director
Sparta Systems

12:00

 

Networking Luncheon

1:00

Choose Between Two 90-Minute Sessions (5-6)

5Documentation — New Expectations Driven by the Pharmaceutical Quality System

I.ICH Q10 — The Pharmaceutical Quality System

II.ICH Q8 — Pharmaceutical Development

III.ICH Q9 — Quality Risk Management

IV.Process Validation Guidance

V.Quality Metrics

Jerry Lanese, Ph.D.
President
The Lanese Group, LLC

6Define Risk and Risk Levels – Implement ICH Q9 Quality Risk Management

I.Identify, Manage and Control Risk

II.Develop Quality Risk Management Process

III.Define System Boundaries

IV.Pitfall in QRM

V.Interactive Exercise

Amjad Ganma
Senior Quality Unit Manager
Tabuk Pharmaceutical Company

2:30

Networking and Refreshment Break
Office Hours — Meet one-on-one with speakers to solve your individual Quality and Change Control challenges.

3:00

BRING YOUR OWN CHALLENGE WORKSHOP

Practical Qualitative and Quantitative Approaches to Quality Risk Management

Willis H. Thomas, Ph.D., PMP, CPT
Director, Training and Development
Akorn Pharmaceuticals

4:30

Close of Day Two

DAY THREE| THURSDAY, MARCH 1, 2018

8:00

Continental Breakfast

8:30

One Size Does Not Fit All – Creating and Applying Custom Risk Management Tools

I.Explore Common Risk Tools

II.Understand When a Custom Risk Tool is Appropriate

III.Less-Formal Risk Tool Approaches

IV.Defining the “What”

V.Develop Ranking Criteria and Action Tables for a Custom Risk Tool

VI.Implement a Custom Risk Tool

VII.Interactive Exercise

Amanda B. McFarland
Senior Consultant
ValSource, LLC

There will be a 30-minute Networking and Refreshment Break at 10:00

12:00

Networking Luncheon

1:00

Choose Between Two 90-Minute Sessions (7-8)

7Explore Recent FDA Warning Letters and Industry Trends

I.Recent FDA Observations

II.FDA Enforcement Tools

III.Preventing Observations

IV.Cleaning Up After the Observation

Jerry Lanese, Ph.D.
President
The Lanese Group, LLC

8CASE STUDY | Supplier Qualification and Management

Aida Markham, CQE, CQA
Vice President, Compliance
QACV Consulting

2:30

Networking and Refreshment Break
Office Hours - Meet one-on-one with speakers to solve your individual Quality and Change Control challenges.

3:00

Choose Between Two 90-Minute Sessions (9-10)

9Senior-Level Think Tank — Strategies for the Advanced Quality Professional*

Parth Sampathkumar, PhD
Associate Director, Quality Control
Coherus Biosciences

10Assess the Robustness of a Quality Risk Management Program

I.Dive into QRM Technical Maturity

II.Understand and Evaluate QRM Cultural Maturity

III.Interactive Exercise

Amanda B. McFarland
Senior Consultant
ValSource, LLC

4:30

Close of Conference