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  7. 46th International Good Manufacturing Practices Conference - 03/07/2022
  1. Office of Medical Device and Radiological Health Operations (OMDRHO)

Virtual | Virtual

Event Title
46th International Good Manufacturing Practices Conference
March 7 - 10, 2022


Date:
March 7 - 10, 2022
Day1:
- ET
Day2:
- ET
Day3:
- ET
Day4:
- ET

Monday, March 7, 2022

Time                                                               Event/Topic                                                                Speaker

1:30-1:45 p.m.

Welcome and Orientation

Dean Kelly M. Smith & Michael Bartlett

University of Georgia

1:45-2:30 p.m.

Analytical Procedure Lifecycle approach and QbD principles: Holistic view of analytical procedures performance

Amanda Mesquita Guiradelli

USP – Brazil (confirmed)

2:30-2:45 p.m.

Q&A Session

Tuesday, March 8, 2022

Time

Event/Topic

        Speaker

                 MORNING SESSION

8:30-9:15 a.m.

Update from the Office of Regulatory Affairs

Alonza Cruse, FDA ORA

(invited)

9:15-9:45 a.m.

Q&A Session

9:45-10:30 a.m.

Impact of FDA’s Remote Interactive Evaluations in Lieu of On-Site Evaluations During the COVID Pandemic

David Chesney, Chesney Consulting (confirmed)

10:30-11:15 a.m.

Practical Issues and Experiences with Remote Audits and Inspections: An Industry Perspective

Tor Graberg, AstraZeneca

(confirmed)

11:15-11:45 a.m.

Q&A Panel

11:45-1:00 p.m.

Lunch Break

                      AFTERNOON SESSION

1:00-1:45 p.m.

Update from the Office of Manufacturing Quality

Maan Abduldayem, FDA CDER (confirmed)

1:45-2:30 p.m.

MHRA Update

Christine (Chris) Gray, MHRA (confirmed)

2:30-3:00 p.m.

Q&A Panel

3:00-3:45 p.m.

USP Elemental Impurities Chapters and ICH Q3D

Kahkashan Zaidi, USP

(confirmed)

3:45-4:30 p.m.

Management Responsibilities for Data Governance and Data Management

Kir Henrici, Henrici Group (confirmed)

4:30-5:00 p.m.

Q&A Panel

 

Wednesday, March 9, 2022

Time                                                               Event/Topic                                                                Speaker

                 MORNING SESSION

8:15-9:00 a.m.

Case Studies from GMP Inspections

Ileana Barreto-Pettit, FDA, ORA (confirmed)

9:00-9:45 a.m.

Update from Health Canada

TBD, Health Canada

(confirmed)

9:45-10:15 a.m.

Q&A Panel

10:15-11:00 a.m.

Forensic Data Integrity Audits

Brian Duncan, Quality Executive Partners (confirmed)

11:00 a.m. - 11:45 p.m.

Handling the Inevitable: GMP Investigations with Data Integrity Concerns 

 

Peter Baker, Green Mountain Quality Assurance (confirmed)

11:45-12:15 p.m.

Q&A Panel

12:15-1:00 p.m.

Lunch Break

 

                     AFTERNOON SESSION

1:00-1:45 p.m.

GMP Challenges in Development of a COVID-19 Vaccine

Richard Tarrant, Oxford University (confirmed)

1:45-2:30 p.m.

Update from OPPQ

Ashley Boam, FDA CDER

(confirmed)

2:30-3:00 p.m.

Q&A Panel

3:00-3:45 p.m.

Legal Considerations for Senior Executives Related to Quality Culture

Peter Lindsay, Paul Hastings (confirmed)

3:45-4:30 p.m.

Management’s Responsibilities in Establishing a Sustainable Quality Culture

Frances Marie Zipp, Lachman Consultant Services (confirmed)

4:30-5:00 p.m.

Q&A Panel

 

Thursday, March 10, 2022

Time                                                               Event/Topic                                                                Speaker

                  MORNING SESSION

8:15-9:00 a.m.

Quality Metrics and Maturity – Keys to Quality Excellence

Steve Greer, Genesis Assist (confirmed)

9:00-9:45 a.m.

FDA Quality Metrics Program:  Past, Present, and Future

Hui-I Tom, FDA CDER

(confirmed)

9:45-10:15 a.m.

Q&A Panel

10:15-11:00 a.m.

QMS for Combination Products for Sites that Produce Both Drugs and Devices

Jennifer Ahearn, Engineering Systems (confirmed)

11:00 a.m. - 11:45 p.m.

Business Benefits of Risk-based Computer System Validation

Mark Matis, Pharma IT Quality Solutions (confirmed)

11:45-12:15 p.m.

Q&A Panel

12:15 p.m.

Conference Adjournment

 

 POST-CONFERENCE TUTORIAL

 

1:00-2:30 p.m.

Performing Effective Investigations and Root Cause Analysis

Jennifer Ahearn, Engineering Systems

2:30-2:45 p.m.

Break

2:45-4:00 p.m.

Performing Effective Investigations and Root Cause Analysis (continued)

Jennifer Ahearn, Engineering Systems

4:00 p.m.

Post-Conference Adjournment

 

Continuing Education (CE) credit available through this tutorial only.

 
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