Thank you This live web event has ended. Thank you for attending. Contributors Kim Hunyh-Ba Kim Huynh-Ba has 28 years of experience in quality management system, project management, strategic drug development and stability sciences. She currently is the Executive Director of Pharmalytik (www.pharmalytik.com). Since 2003, she has provided consulting and training services to pharmaceutical companies, including companies operating under FDA’s Consent Decree and supporting their quality systems. Her clients are from various sizes of pharmaceutical companies in US and abroad. Kim is also a short course instructor on cGMP compliance and quality topics for several global organizations such as American Chemical Society (ACS), American Association of Pharmaceutical Scientists (AAPS), Pittsburgh Conference, and many other international training groups. She is an Adjunct Professor at Temple University-School of Pharmacy, Widener University and Illinois Institute of Technology (IIT) teaching Quality Audit, Good Manufacturing Practices, ICH regulations, and Pharmaceutical Analysis. Karyn Campbell Karyn is the Director of Investigations Branch II, Division of Pharmaceutical Quality Operations I, and is located in Philadelphia, PA. Prior to ORA’s May 2017 reorganization, she was the Investigations Branch Director for the Philadelphia District Office. Karyn has been with FDA in Philadelphia for 34 years. She is responsible for managing planned and unplanned inspections, investigations, examinations, and sample collections of the regulated pharmaceutical industry in Pennsylvania, Delaware, Maryland, Virginia, West Virginia, District of Columbia, and New York. She is also a member of several FDA committees and working groups pertaining to human drugs. Prior to her current position, she held the positions of Assistant Investigations Branch Director, Pre-Approval Inspection Manager, Compliance Officer, and Investigator. Karyn provides training in FDA law, evidence development, pharmaceutical inspections, and compliance issues internally at FDA and to industry. She has been a guest lecturer at several academic institutions including Temple University, Dickinson School of Law, and Widener University School of Law. She is currently an Adjunct Associate Professor at Temple University’s School of Pharmacy, where she co-teaches a course in Pre-Approval Inspections in the Regulatory Affairs/Quality Assurance graduate degree program. She holds a B.S. in Biology from Gwynedd-Mercy University.