Companies are currently being driven to consider alternatives to traditional on-site audits, and face new challenges with remote auditing. Where to begin, and how to plan and prepare for a remote assessment? The panel will share strategies to address:
New Approaches, Planning & Scope, Communication, Technology, Secure Collaboration for Information Sharing, Off-Site Limitations.
Donna Gulbinski – Chief Quality & Regulatory Affairs Officer at Civica Rx with a 30+ year industry career. Donna has held prior positions in Quality and GxP Compliance, including roles in drug discovery, operations, quality, and regulatory affairs at Merck & Co., Bristol Myers Squibb, and Lachman Consultants.
Jennifer Darr – Manager of Quality Assurance at Civica Rx with a focus on virtual business models. Jennifer has worked in the manufacturing space of the pharma industry since 2007, and started at a small molecule API facility operated by Roche/Genentech. As a certified ASQ Lead Auditor, she has inspected facilities worldwide. Jennifer holds Bachelor’s degrees in both Biology and Chemistry.
Tony Thesing – Senior Manager in Quality Systems & Compliance at American Regent, responsible for Inspections/Audits, Complaint Management, Investigations, CAPA, Change Control, and Annual Product Reviews. Since 2006, Tony has had prior roles in Quality, Compliance, and Microbiology at Dow Corning and Teva Pharmaceuticals. He holds a Bachelor’s Degree in Biology from the University of Cincinnati, and a MBA from the Florida Institute of Technology.
Laurel Hacche – Field Engineering Director at SQA with 30+ years of industry experience. Before SQA, Laurel was Senior Director of Third Party Manufacturing and Director of Worldwide Quality Assurance at Allergan, Inc, and served as the lead corporate QA liaison for the FDA and other regulatory agencies. She has a PhD in Physical Polymer Chemistry from UC Irvine and an AB in Chemistry from Occidental College.
Hosted By – PDA SoCal Chapter and SQA