Understanding EU Product Sampling Processes During an Unannounced Audit
1 Hour Video | Florianne Torset-Bonfillou, LNE / G-MED North America, Inc.
Under the EU Commission Recommendation (2013/473/EU), notified bodies are now required to conduct unannounced audits with medical device and diagnostic manufacturers and their crucial suppliers once every two years. During these audits, notified bodies will validate the quality and consistency of manufacturing protocols by checking “a recently produced sample, preferable taken from the ongoing manufacturing process” for compliance. This can include taking samples from the manufacturing site and testing them in a separate location, as well as auditing products that are not currently manufactured. In order to ensure a successful audit, manufacturers must have knowledge on how notified bodies are inspecting samples and other critical processes.
- Notified body criteria for selecting and testing samples
- Appropriate handling for on-site and off-site testing
- Training and preparing internal staff for audit sampling
Participants that will find this webinar most beneficial will be those involved in medical device companies. Job titles of attendees that will be most applicable for this session will be:
- Regulatory Affairs
- Quality Assurance
- Legal Counsel
Technical Department Director – Lead Auditor
LNE / G-MED North America, Inc.
Florianne Torset- Bonfillou is currently the Technical Department Director of LNE/G-MED North America. She received her Bachelor’s Degree in Biology from the University of Burgundy and her Master’s Degree in Chemistry from University of Paris 12. She holds a professional certificate in Quality, Safety and Environmental Management. Prior to joining LNE/G-MED, Florianne worked in the Pharmaceutical and Medical Device industry as a Quality Assurance Project Manager. At LNE/G-MED, Florianne is a Senior Design Dossier Reviewer and Lead auditor. Her main fields of qualification include Cardiovascular and Neurovascular Devices, Orthopedic and Dental Implants, Ophthalmology products, Wound Dressing, and more high-risk and innovative devices. She is also a trainer on the European Regulation, Quality Management, Risk Management, and other regulatory and quality topics.