StarFish Medical Director of Quality Assurance and Regulatory Affairs, Vesna Janic, and Quality Assurance and Regulatory Affairs Specialist, Cam Neish, delivered two expert presentations focused on strategies for handling FDA inspections and managing risk associated with medical devices at the 5 October 2016 RAPS Vancouver BC chapter meeting in Burnaby, BC. Also pictured is Virginia Anastassova. Virginia is part of the RAPS chapter executive leadership. She organized the event and sent us this photo.
Case Study—Tales from Two FDA Inspections at Three Facilities
Most QA/RA professionals have attended generalized training on how to handle FDA inspections. However, few have participated in a real inspection from notification and preparation through inspection and follow-up. This case study examines three recent FDA inspections and is presented by a participant in the inspections. Highlights include a novel inspection strategy, lessons learned, preparation efforts, the actual inspections and inspection outcomes.
Risk Management
A detailed overview of the risk management process will be presented, including examples of tools and techniques used. Topics to be covered include:
- ISO 14971 – Application of risk management to medical devices
- ISO 13485 – Medical devices, quality management systems and requirements for regulatory purposes
- IEC 60601-1 – Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
Register here. You can also register by calling +1 301 770 2920 ext. 200