Unannounced Audit Best Practices and Notified Body Communications
1 Hour Video | Sarah H. Stec, Esq., RAC, LNE/G-MED North America, Inc.
Under the EU Commission Recommendation 2013/473/EU, unannounced audits must become an established practice for medical device manufacturers as well as notified bodies. In addition to standard auditing requirements, the Recommendation requires notified bodies to visit device manufacturers and applicable critical sub-contractors and crucial suppliers at least once every three years to ensure they are fulfilling compliance requirements. Notified bodies must also demonstrate consistency with competent authorities in each EU jurisdiction. The following presentation will include new information on unannounced audits and a notified bodies experience to date, and provide attendees with a better understanding of how notified bodies are executing the recommendations and how they are communicating with each other.
- Brief review of Commission Recommendation
- Unannounced audit preparation and post-audit responsibilities
- Incorporating CAPAs into regulatory audit structure
- Updates in notified body communication and code of conduct
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
This webinar has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for up to 1.5 credits towards a participant’s RAC recertification upon full completion.
Sarah Stec is currently the Legal and Regulatory Director of G-MED North America, Inc. She received her law degree from the Penn State Dickinson School of Law, where she specialized in international commercial arbitration and life sciences legal issues. Sarah received her RAC (EU) certification in 2014. At G-MED, Sarah is the North American point of contact for regulatory questions from clients and internally, and handles a wide range of commercial and international legal issues that arise.