In this 65 minute follow-on webinar to “FDA Just Called – Now What?” MasterControl’s Walt Murray outlined the steps to take once the inspection is complete, the Form 483 issued, and responses that must be made. The session includes Q&A from the audience specifically addressing the 15-day window and how many days to expect FDA to be on site.
Key takeaways include:
- The major FDA findings
- Appropriate Response types
- Handling the CAPA(s) for the findings
- Updating FDA on progress
About the Presenters:
Linda Chatwin Esq. RAC – Business Manager, UL
Ms. Chatwin has been involved with regulated medical products for over 30 years. She understands the regulatory maze required to bring products to market. She holds a Regulatory Affairs Certification and is an attorney in the U.S. She has obtained product approvals for a wide range of products, and remains involved in changing requirements for medical devices worldwide. Currently, she heads the North American Advisory Services group for UL, LLC, assisting clients with regulatory issues and challenges, including implementation of UDI processes. Ms. Chatwin travels worldwide to speak about changing market access issues.
Walt Murray, MasterControl
Walt Murray is a quality management and regulatory affairs professional with more than 32 years of experience working with internationally recognized, highly regulated companies, including Aventis-Pasteur, Merck, Pfizer, Stryker, USANA and Del Monte Foods. A Six Sigma Black Belt, Murray is certified in quality and environmental systems auditing (AQS Systems), critical-thinking skills and process control. He also has extensive training and consulting expertise in quality event/CAPA management, risk management, supplier control and audit management.
Having personally performed more than 200 third-party audits, for a variety of Fortune 500 life sciences companies, Murray has hosted investigational and systems audits by the FDA, Therapeutic Goods Administration (TGA), Medicines and Healthcare Products Regulatory Agency (MHRA) and Health Canada.
Murray holds a Bachelor of Science degree in analytical chemistry from the University of Richmond and has completed graduate-level coursework at the University of Tennessee, Knoxville. He is an active member of the Society of Manufacturing Engineers (SME), the Regulatory Affairs Professional Society (RAPS), the American Society for Quality (ASQ), the Society for Quality Assurance (SQA) and the Intermountain Biomedical Association (IBA), as well as board member of BioUtah’s Compliance Forum. His broad knowledge base makes him a much sought-after speaker at national and international compliance forums such as MD&M, AdvaMed, SQA, INTERPHEX and others.
Currently, Murray leads the quality and compliance consulting services division of MasterControl, a leading provider of quality management software solutions to regulated companies worldwide.