When: Tuesday, November 20, 2012 11:00 am ET
When dealing with contract manufacturing organizations (CMO's), the buck stops with the operating company. For any pharmaceutical manufacturer today, the best strategy is to analyze and account for any potential risk at the start of any contract negotiations. Often, taking a Quality by Design approach to CMO management can be the best approach.
In this program you will learn how to apply the best QbD and risk management practices to ensure compliance, patient safety and corporate reputation.
Mike Long has two decades of experience leading product, process and validation development efforts on a wide range of pharmaceutical, bio pharm, medical device, and combination products. Prior to Concordia, Mike served as Director of Engineering at Cooper Surgical, where he led the product development and manufacturing engineering teams. At AstraZeneca Mike held multiple management roles within the technical services organization. Mike was also member of AZ’s Lean Operations team responsible for restructuring U.S. operations. At J&J's Cordis, Mike managed process, equipment and facility development at various global sites launching the Cypher drug eluting stent.
Mike is a Master Black Belt who earned a bachelor’s degree from Worcester Polytechnic Institute, a Master’s degree from Tufts University and a Doctorate from Northeastern University. He is currently editing a book on risk management in pharmaceutical and biopharmaceutical manufacturing to be published in 2012.