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DTSTART:20240910T130000Z
DTEND:20240911T203000Z
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SUMMARY:Dealing with Related Substances Impurities in Pharmaceutical Products
DESCRIPTION:In-person Workshop\nDate: September 10-11, 2024, Toronto Canada\nTime: 9AM to 4:30 PM\nAgenda\nPart 1 – Related Substances\nIntroduction\nReview of Relevant\nICH Guidelines Q3A and Q3B\nSources of Synthesis Impurities\nChemistry of Drug Degradation and Forced Degradation Studies\nInteractive Exercise 1:\nQuantifying Related Substances\nDevelopment/Validation of Analytical Methods for Impurities\nUnderstanding Chiral Impurities\nInteractive Exercise 2:\nInterpretation of Related Substances Data in Stability Studies\nDay 2 – N-Nitrosamine Impurities\nWhat are Nitrosamine Impurities?\nUnderstanding Regulatory Guidelines for Nitrosamine Impurities\nConducting Risk Analyses\nFollow Up Studies\nInteractive Exercise 3:\nDesign a Protocol for a Nitrosamine Risk Assessment\nFinal Discussion Session\n \n\nSpeaker:\n\nDr. Geoff Carr\nGeoff 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.\n \n\nWho Should Attend:\nThis unique two-day course and workshop is designed for professionals in the pharmaceutical, biopharmaceutical and allied industries with responsibilities in the following areas:\n\n\nAnalytical R&D\n\n\nQuality Control\n\n\nQuality Assurance\n\n\nRaw Materials Testing\n\n\nProduct Development\n\n\nFormulation\n\n\nChemistry, Manufacturing and Controls (CMC)\n\n\nPre-Clinical Research\n\n\nRegulatory Affairs\n\n\nContract Laboratories\n\n\nConsultants\n\n\nOther Compliance professionals\n\n\n \n\n2 Days In-Person Course/Workshop\nRegistration Fees:\nEarly Bird (Register before or on August 16, 2024): $788\nRegular Price (Register after August 16, 2024): $888\nCourse Venue will be available soon.\nGroup registration is available, please contact by email: enquiry@ipacanada.com ( mailto:enquiry@ipacanada.com )\nAll participants will receive certificate of attendance upon completion of the course/Workshop.\n \nRegister Today!\n
URL:https://ipacanada.com/events/impurities-24/
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