Rock the FDA Audit - by establishing a Great QMS!
Hello and welcome to Episode 6 of Software Tech Talks - How the Pros build Reliable Products. Today's featured guess is Jan Dziewior, a highly experienced regulatory executive with over 25 year's experience developing and expanding processes for product monitoring and complaint handling for medical device manufacturers. Her priorities include managing the complaint handling process in order to identify critical issues that impacted medical devices, and ensure they're mitigated quickly and systematically. With Jan's answers to highly important FDA and Regulatory Compliance Questions - we believe you should be able to establish a much stronger QMS Process and enjoy more reliable product releases!