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
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Time Event/Topic Speaker |
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1:30-1:45 p.m. |
Welcome and Orientation |
Dean Kelly M. Smith & Michael Bartlett University of Georgia |
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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) |
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2:30-2:45 p.m. |
Q&A Session |
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Tuesday, March 8, 2022
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Time |
Event/Topic |
Speaker |
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MORNING SESSION |
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8:30-9:15 a.m. |
Update from the Office of Regulatory Affairs |
Alonza Cruse, FDA ORA (invited) |
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9:15-9:45 a.m. |
Q&A Session |
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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) |
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10:30-11:15 a.m. |
Practical Issues and Experiences with Remote Audits and Inspections: An Industry Perspective |
Tor Graberg, AstraZeneca (confirmed) |
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11:15-11:45 a.m. |
Q&A Panel |
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11:45-1:00 p.m. |
Lunch Break |
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AFTERNOON SESSION |
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1:00-1:45 p.m. |
Update from the Office of Manufacturing Quality |
Maan Abduldayem, FDA CDER (confirmed) |
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1:45-2:30 p.m. |
MHRA Update |
Christine (Chris) Gray, MHRA (confirmed) |
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2:30-3:00 p.m. |
Q&A Panel |
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3:00-3:45 p.m. |
USP Elemental Impurities Chapters and ICH Q3D |
Kahkashan Zaidi, USP (confirmed) |
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3:45-4:30 p.m. |
Management Responsibilities for Data Governance and Data Management |
Kir Henrici, Henrici Group (confirmed) |
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4:30-5:00 p.m. |
Q&A Panel |
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Wednesday, March 9, 2022
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Time Event/Topic Speaker |
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MORNING SESSION |
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8:15-9:00 a.m. |
Case Studies from GMP Inspections |
Ileana Barreto-Pettit, FDA, ORA (confirmed) |
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9:00-9:45 a.m. |
Update from Health Canada |
TBD, Health Canada (confirmed) |
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9:45-10:15 a.m. |
Q&A Panel |
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10:15-11:00 a.m. |
Forensic Data Integrity Audits |
Brian Duncan, Quality Executive Partners (confirmed) |
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11:00 a.m. - 11:45 p.m. |
Handling the Inevitable: GMP Investigations with Data Integrity Concerns
|
Peter Baker, Green Mountain Quality Assurance (confirmed) |
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11:45-12:15 p.m. |
Q&A Panel |
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12:15-1:00 p.m. |
Lunch Break |
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AFTERNOON SESSION |
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1:00-1:45 p.m. |
GMP Challenges in Development of a COVID-19 Vaccine |
Richard Tarrant, Oxford University (confirmed) |
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1:45-2:30 p.m. |
Update from OPPQ |
Ashley Boam, FDA CDER (confirmed) |
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2:30-3:00 p.m. |
Q&A Panel |
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3:00-3:45 p.m. |
Legal Considerations for Senior Executives Related to Quality Culture |
Peter Lindsay, Paul Hastings (confirmed) |
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3:45-4:30 p.m. |
Management’s Responsibilities in Establishing a Sustainable Quality Culture |
Frances Marie Zipp, Lachman Consultant Services (confirmed) |
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4:30-5:00 p.m. |
Q&A Panel |
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Thursday, March 10, 2022
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Time Event/Topic Speaker |
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|
MORNING SESSION |
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8:15-9:00 a.m. |
Quality Metrics and Maturity – Keys to Quality Excellence |
Steve Greer, Genesis Assist (confirmed) |
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9:00-9:45 a.m. |
FDA Quality Metrics Program: Past, Present, and Future |
Hui-I Tom, FDA CDER (confirmed) |
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9:45-10:15 a.m. |
Q&A Panel |
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10:15-11:00 a.m. |
QMS for Combination Products for Sites that Produce Both Drugs and Devices |
Jennifer Ahearn, Engineering Systems (confirmed) |
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11:00 a.m. - 11:45 p.m. |
Business Benefits of Risk-based Computer System Validation |
Mark Matis, Pharma IT Quality Solutions (confirmed) |
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11:45-12:15 p.m. |
Q&A Panel |
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12:15 p.m. |
Conference Adjournment |
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POST-CONFERENCE TUTORIAL
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1:00-2:30 p.m. |
Performing Effective Investigations and Root Cause Analysis |
Jennifer Ahearn, Engineering Systems |
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2:30-2:45 p.m. |
Break |
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2:45-4:00 p.m. |
Performing Effective Investigations and Root Cause Analysis (continued) |
Jennifer Ahearn, Engineering Systems |
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4:00 p.m. |
Post-Conference Adjournment |
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Continuing Education (CE) credit available through this tutorial only. |
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