The MDSAP Audit Process: Latest Developments and Best Practices – Webinar Recording/Transcript
For devicemakers hoping to enter the global market, the Medical Device Single Audit Program (MDSAP) is a must.
MDSAP success can get your devices to market faster and it precludes being subject to routine FDA inspections, leading to a much less stressful relationship with the FDA.
If the FDA or ISO audit is what you’re used to, this presentation — filled with the latest developments, best practices and tips — is your ticket to MDSAP success.
Connie Hoy of Hoy & Associates Regulatory Consulting will cover all of this, so you can reap the benefits. Having successfully led multiple companies through the MDSAP preparation and audit process — and having been part of the pilot program — she’ll share lessons learned and the latest insights into what you must know and do to obtain certification.
- How to prepare successfully using the MDSAP Companion Document
- How to ensure your quality system completely covers specific country requirements
- What to expect in the audit’s registration review portion
- How the MDSAP audit is conducted and how differs from an FDA inspection or ISO audit
- What the grading system for nonconforming really means
- Which specific areas of emphasis are different in the MDSAP audit from an ISO audit
- What to expect when conducting internal audits under MDSAP
Pass your next MDSAP audit with the practical, must-know information you’ll take away from this presentation.
Meet Your Presenter
Connie Hoy of Hoy & Associates Regulatory Consulting is a former EVP of regulatory, quality and clinical development at Cynosure, a division of Hologic, with three decades of experience in the medical device industry. She was so enthusiastic about the MDSAP program, she volunteered to have Cynosure participate in the pilot program in 2016. This put the company at the forefront of compliance with the program, so by the time most companies were having their first assessment, Cynosure had already had two certification audits and two surveillance audits. Since leaving Cynosure in 2018, Ms. Hoy led a number of companies through the process of obtaining MDSAP certification. She also performs internal audits that meet the requirements of MDSAP.
Who Will Benefit
- Regulatory and quality professionals involved in managing external quality audits
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Nov. 11, 2021