This webinar by expert speaker Dr. Dave Elder will provide insight into the historical background to the introduction of the microbiology contamination guidance for non-sterile oral drug products. You will learn about different risk assessments and the holistic nature of control strategies and the different approaches that can be taken.
Also, you will gain insight into the concerns around objectionable organisms as well as the issues associated with these organisms. Lastly, the session will explain the implications of change control on established products.
Who Should Attend
The webinar will be useful to all individuals involved in developing and filing novel drug products. In particular, those involved in manufacturing, packaging and release testing of drug products. In addition it will be insightful to excipient suppliers.
Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.
Dr. Dave Elder studied chemistry at Newcastle upon Tyne (BSc, MSc), before moving to Edinburgh to study for a PhD in Crystallography. He is a visiting professor (King’s College, London). He has 38-years of experience at a variety of different pharmaceutical companies (Sterling, Syntex and GSK). Dr. Elder was a director within the product development group in GSK R&D, but is now an independent consultant.
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