Mike Overton is a Senior Consultant with NNE Pharmaplan, based in Cambridge MA. Mike provided compliance and operations consulting to clients in the medical device, biopharmaceutical and pharmaceutical industries. Mike has extensive experience in the biopharmaceutical industry gained through more than 25 years direct experience. Mike has served in various capacities including VP of Manufacturing and Plant Operations, Plant Manager, Director of Manufacturing and Bioprocessing Manager. Mike has worked for some of the leading biopharmaceutical companies including: Biogen Idec, Pfizer (Wyeth), Sanofi Pasteur (Acambis). For the last 5 years Mike has been consulting both independently and with NNE Pharmaplan. Mike has had many varied and interesting clients and consulting projects. Some recent examples of Mike’s consulting projects include; performing process risk assessments for a client to understand manufacturing process factors that were resulting in a low product release rate, performing risk assessments for a biologics manufacturer in preparation of a Type C meeting with the FDA and advising a client on the compliance requirements to transition from a medical device manufacturer to a manufacturer of combination products.