Practical Approaches to New Audit Formats Part 1: MDSAP
While medical device manufacturers are well familiarized with regulatory inspections and audits from a variety of sources, new audit formats are challenging quality assurance and regulatory affairs executives. The first of this series of discussions will focus on the increasing number of audits required for companies marketing their products worldwide – and what can be done to manage this burden.
- Establishing a single regulatory strategy for numerous markets
- Practical application of the MDSAP guidance and plan
- MDSAP audit completion
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
Director of Quality & Regulatory Affairs
Patricia Schnoor is an accomplished industry professional with over 30 years of experience in the medical device field, including coordinating global regulatory affairs and quality assurance activities. She currently serves as the Director of Quality & Regulatory Affairs at Capillus, where she is responsible for market access submissions (FDA, current and completed), administering all phases of device safety and regulatory compliance programs for worldwide market access, and performing post-market surveillance and complaint management. With a multitude of successful regulatory submissions to USFDA, EU, Brazil, Korea, Australia and others, Patricia possesses applied knowledge of worldwide regulations both for medical and non-medical (borderline) devices such as IEC 60335, IEC 60601, ISO 14971, J-PAL, CMDCAS, ICH, ANVISA, TGA, US Code of Federal Regulations (e.g. 21 CFR 820), current Good Manufacturing Practices (cGMP), and US State Statutes. In addition to the regulatory submissions, Patricia has led 2 European sites to achieve ISO 13485 and GMP compliance and led another manufacturing site to successful MDSAP certification during the pilot program.
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