Part I: Supplier QualificationPart II: Engineering Impact in Business and Quality Systems This practical training will benefit professionals and associates in the Pharmaceutical, Biotechnology, and Medical Device industries including individuals in the following functions: Quality Assurance, Quality Control, Compliance, Managers of Contract Manufacturing Organizations (CMO’s), Auditors, Purchasing, Material Management, Supply Chain, Outsourcing Project Managers, Technical Operations, Tech Services, Regulatory Affairs, and Production Operations. The visibility of Supplier Qualification to regulatory agencies has increased in recent years. Supplier Qualification is the foundation upon which supplier relationships are built. Every company strives to obtain their desired supply chain expectations even as the complexity of relationships with suppliers and contractors increases. This training will outline the fundamentals for a robust and compliant Supplier Qualification process for FDA regulated industries with a focus on the application of risk management techniques. CEUs will be given to all attendees who pass the assessments with a score of 70% or higher. Those who don’t pass will have an opportunity to receive CEUs if they correct their answers as they go over the assessments with trainer. Course Director: Frank Carroll, Principal Consultant, Carroll Pharma Consulting, LLC Frank Carroll is currently an independent pharmaceutical operations/supply chain consultant and Principal of Carroll Pharma Consulting, LLC. He has over 25 years’ experience in the Pharmaceutical, Device, Biologics, and Biotech industries in many aspects of operations including commercial and clinical product manufacturing and supply chain; purchasing; strategic alliance management; implementation of advanced project management systems; MRP/ERP systems; and senior operations management. He has held senior consulting positions at Pharmatech Associates and senior management positions at Zosano Pharma, Genitope Corp., Alpha Therapeutics, McGhan/Inamed Corp., Collagen Corp., and Bayer AG. He has earned certifications from APICS (CPIM), ASQ (CQE), and Zenger-Miller as a certified trainer. He has instructed/directed numerous courses for the Center for Professional Advancement, instructed courses for APICS CPIM certification, and was a faculty member at Indiana University at South Bend in Continuing Education programs. He received his B.Sc. degree from The Ohio State University and MBA and MSBA degrees from Indiana University at South Bend.