Dealing with Related Substances Impurities in Pharmaceutical Products
In-person Workshop
Date: September 10-11, 2024, Toronto Canada Time: 9AM to 4:30 PM
Agenda
Part 1 – Related Substances
Introduction
Review of Relevant
ICH Guidelines Q3A and Q3B
Sources of Synthesis Impurities
Chemistry of Drug Degradation and Forced Degradation Studies
Interactive Exercise 1:
Quantifying Related Substances
Development/Validation of Analytical Methods for Impurities
Understanding Chiral Impurities
Interactive Exercise 2:
Interpretation of Related Substances Data in Stability Studies
Day 2 – N-Nitrosamine Impurities
What are Nitrosamine Impurities?
Understanding Regulatory Guidelines for Nitrosamine Impurities
Conducting Risk Analyses
Follow Up Studies
Interactive Exercise 3:
Design a Protocol for a Nitrosamine Risk Assessment
Final Discussion Session
Speaker:
Dr. Geoff Carr
Geoff Carr PhD, Pharmaceutical Consultant has over 45 years experience of working in the pharmaceutical industry and currently provides training and consultancy services to pharmaceutical companies. Previously, he was appointed as Manager, Analytical Development at Patheon Inc, Canada in 2000 and progressed to Director, Analytical Development, Thermofisher Patheon until 2023. Prior to that, he held positions of Manager, Analytical Sciences at Celltech-Chiroscience, UK, Head of Analytical Development at Medgenix, Belgium and before that at Wyeth Research, UK. He originally started his career in pharmaceutical analysis at The British Pharmacopoeia Laboratory where he held several posts and was finally appointed Head of the Laboratory. His academic background is a PhD in synthetic organic chemistry awarded by University of London, UK. He has been a Member of various British Pharmacopoeia Committees, a UK representative to Committees of the European Pharmacopoeia and Member of USP Committees including a Member of the 2015-2020 Cycle USP General Chapters – Physical Methods Expert Committee. He is the author of numerous papers, presentations at international conferences and workshops on various topics related to applications of analytical chemistry during the development of pharmaceutical products.
Who Should Attend:
This unique two-day course and workshop is designed for professionals in the pharmaceutical, biopharmaceutical and allied industries with responsibilities in the following areas:
Analytical R&D
Quality Control
Quality Assurance
Raw Materials Testing
Product Development
Formulation
Chemistry, Manufacturing and Controls (CMC)
Pre-Clinical Research
Regulatory Affairs
Contract Laboratories
Consultants
Other Compliance professionals
2 Days In-Person Course/Workshop
Registration Fees:
Early Bird (Register before or on August 16, 2024): $788
Regular Price (Register after August 16, 2024): $888
