Although unannounced GMP inspections happen when you least expect them, it is possible to predict when they occur. With this knowledge, you can predict when you must be ready. By examining the "hot topics" and your track record with the agency, you will be able to determine what the most likely areas to be covered are. This becomes the plan for gap analysis and checking on what you said you would do at the last inspection. The successful inspection is when you manage your agency’s expectations and then deliver on them. After the inspection, the responses are also very critical to prevent it from becoming a warning letter or even worse.
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Who will benefit:
This webinar will walk you through the elements you should plan for, the timing and the logistics of who should do the various components in preparation for the inspection. We will walk you through successful inspection strategies and logistics. After the inspection the putting together of a solid systemic CAPA is described and a process for tracking completion.
Peter Calcott, Ph.D.is the founder and president of Calcott Consulting, a consulting form focused on delivering solutions in supply chain, manufacturing, quality, clinical development and regulatory affairs for biologics and drug companies. He has presented at national meetings and is active in the biotechnology community vie BIO and the bay area BayBio trade associations where is chairman of the BIO RAC committee and a Board member of BayBio. He has over 30 years experience working at small start-up biotech as well as large Pharma companies in the areas of manufacturing, process science, and quality, clinical and regulatory affairs.
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