Course Description:
In this USP-BP joint workshop that was held over two days, speakers from industry, various international expert groups, the Medicines and Healthcare products Regulatory Agency (MHRA), U.S. Food & Drug Administration (U.S. FDA), U.S. Pharmacopeial Convention (USP), and the British Pharmacopoeia (BP) discussed the use of Analytical Quality by Design concepts across the Analytical Procedure Lifecycle.
This workshop included examples of specific case studies, experiences of members with various AQbD concepts, presentations at the cutting edge of AQbD advancements, and the latest regulator views on the developing science.
Who should participate:
- Compendial Liaison
- Consultant
- Executive
- Healthcare Practitioner
- QA Manager
- QA Staff
- QC Chemist
- QC Manager
- R&D
- Regulatory
- Student
The live version of this recording took place on September 30-October 1, 2021
Access Duration:Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.
Speakers
- James Pound, Acting Deputy Director Inspection, Enforcement and Standards Secretary and Scientific Director, MHRA
- Horacio Pappa, Ph.D., Senior Director, General Chapters, USP
- Phil Borman, D.Sc., Senior Fellow and Director of Product Quality, GSK
- Jörg Hoffmann, Ph.D., Director, Reg.CMC Marketed, Merck Healthcare KGaA
- Stephen Young, Head of Analytical Science, MHRA
- Rosario LoBrutto, Ph.D., Executive Director, Head of Scientific Affairs, Sandoz
- Kimber Barnett, Ph.D., Research Fellow, Pfizer
- Phil Nethercote, Ph.D., Independent Consultant
- Tim Schofield, M.A., Owner & Consultant, CMC Science, LLC
- Joachim Ermer, Ph.D., Owner, Ermer Quality Consulting
- Laxsaan Elanganathan, MSc., Senior Pharmacopoeial Scientist, MHRA
- Jane Weitzel, USP Expert Volunteer (Chair of General Chapters, Measurement & Data Quality Expert Committee)