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DAY ONE TUESDAY, SEPTEMBER 26, 2017

7:30

Registration and Continental Breakfast

8:30

Chairman’s Welcome and Opening Remarks

Brian M. Spencer
Director, Quality Assurance, Lilly Chorus
Eli Lilly and Company

8:45

A Practical Application of Supplier Risk Management

Marte Cabello
Associate Director, Quality Systems Analytics
Alexion Pharmaceuticals

9:30

Risk-Based Supplier Qualification and Management —
A Tool for Preventing FDA Enforcement Actions

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

10:15

Networking and Refreshment Break

10:45

90 MINUTE EXTENDED SESSION Conducting Drug Product Supplier Audits — Using Risk As Guidance

I. Auditing Your Supplier

II. Applying Risk Assessment

III. Conducting the Audit

IV. Interactive Exercise

Gamal Amer, PhD
Principal
Premier Compliance Services, Inc.

12:15

Networking Luncheon

1:30

Strengthen Your Quality Systems by Establishing GxP Intel Programs to Monitor Current Regulations and Guidance, Inspection Results, Warning Letters and Trends

Leslie A. Paul
Associate Director, GCP Audit Services, Falcon Consulting Group, Inc;
former Associate Director, Corporate Quality Compliance, Perrigo

2:15

Why you should automate Third-Party Audits

Tom Middleton
eQMS Solutions Architect
Sparta Systems

3:00

Assessing the Impact of Supplier Changes and Supplier Change Notifications on Current Products

Alan M. Golden, MS
Principal Quality Professional
Abbott Molecular

3:45

Networking and Refreshment Break

4:15

FDA Lifecycle Approach to Process Validation —
Application to Supplier Audits and Quality Systems

Paul L. Pluta, PhD
Editor-in-Chief, Journal of Validation Technology and
Journal of GXP Compliance, IVT/CBI/UBM;
Associate Professor of Biopharmaceutics
University of Illinois at Chicago (UIC) College of Pharmacy

5:00

Close of Day One

Networking, Wine and Cheese Reception immediately following the final session on day one

DAY TWO WEDNESDAY, SEPTEMBER 27, 2017

7:30

Continental Breakfast

8:30

Chairman’s Review of Day One

Brian M. Spencer
Director, Quality Assurance, Lilly Chorus
Eli Lilly and Company

8:45

Quality of Supplier of Computer System

Isabel Rodriguez, PE, CSQE
President
IRP Consulting, LLC

9:30

Auditing and Qualifying Sterile Compounding Facilities —
A How-to Guide and In-Depth Discussion on the Technical Aspects of The Audit

Brian M. Spencer
Director, Quality Assurance, Lilly Chorus
Eli Lilly and Company

10:15

Networking and Refreshment Break

10:45

90 MINUTE EXTENDED SESSION Proper Audit Planning to Ensure Maximum Effectiveness and Efficiency

I. Interactive Discussion — What Constitutes a Successful Audit?

II. Audit Schedules

III. Audit Planning

IV. Audit Conduct

V. Audit Reporting

VI. Follow-Up Processes

Chris Wubbolt
President
QACV Consulting

12:15

Closing Remarks

12:30

Close of Conference

Want more agenda details? Download the brochure.

DAY ONE TUESDAY, SEPTEMBER 26, 2017

7:30

Registration and Continental Breakfast

8:30

Chairman’s Welcome and Opening Remarks

Brian M. Spencer
Director, Quality Assurance, Lilly Chorus
Eli Lilly and Company

8:45

A Practical Application of Supplier Risk Management

Marte Cabello
Associate Director, Quality Systems Analytics
Alexion Pharmaceuticals

9:30

Risk-Based Supplier Qualification and Management —
A Tool for Preventing FDA Enforcement Actions

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

10:15

Networking and Refreshment Break

10:45

90 MINUTE EXTENDED SESSION Conducting Drug Product Supplier Audits — Using Risk As Guidance

I. Auditing Your Supplier

II. Applying Risk Assessment

III. Conducting the Audit

IV. Interactive Exercise

Gamal Amer, PhD
Principal
Premier Compliance Services, Inc.

12:15

Networking Luncheon

1:30

Strengthen Your Quality Systems by Establishing GxP Intel Programs to Monitor Current Regulations and Guidance, Inspection Results, Warning Letters and Trends

Leslie A. Paul
Associate Director, GCP Audit Services, Falcon Consulting Group, Inc;
former Associate Director, Corporate Quality Compliance, Perrigo

2:15

Why you should automate Third-Party Audits

Tom Middleton
eQMS Solutions Architect
Sparta Systems

3:00

Assessing the Impact of Supplier Changes and Supplier Change Notifications on Current Products

Alan M. Golden, MS
Principal Quality Professional
Abbott Molecular

3:45

Networking and Refreshment Break

4:15

FDA Lifecycle Approach to Process Validation —
Application to Supplier Audits and Quality Systems

Paul L. Pluta, PhD
Editor-in-Chief, Journal of Validation Technology and
Journal of GXP Compliance, IVT/CBI/UBM;
Associate Professor of Biopharmaceutics
University of Illinois at Chicago (UIC) College of Pharmacy

5:00

Close of Day One

Networking, Wine and Cheese Reception immediately following the final session on day one

DAY TWO WEDNESDAY, SEPTEMBER 27, 2017

7:30

Continental Breakfast

8:30

Chairman’s Review of Day One

Brian M. Spencer
Director, Quality Assurance, Lilly Chorus
Eli Lilly and Company

8:45

Quality of Supplier of Computer System

Isabel Rodriguez, PE, CSQE
President
IRP Consulting, LLC

9:30

Auditing and Qualifying Sterile Compounding Facilities —
A How-to Guide and In-Depth Discussion on the Technical Aspects of The Audit

Brian M. Spencer
Director, Quality Assurance, Lilly Chorus
Eli Lilly and Company

10:15

Networking and Refreshment Break

10:45

90 MINUTE EXTENDED SESSION Proper Audit Planning to Ensure Maximum Effectiveness and Efficiency

I. Interactive Discussion — What Constitutes a Successful Audit?

II. Audit Schedules

III. Audit Planning

IV. Audit Conduct

V. Audit Reporting

VI. Follow-Up Processes

Chris Wubbolt
President
QACV Consulting

12:15

Closing Remarks

12:30

Close of Conference