Medical Device Single Audit Program (MDSAP) – All You Need To Know
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What is MDSAP and where it is going? Will it eventually touch my business anywhere in the world? MDSAP is creating a playing field among regulatory bodies around the world. That playing field consists of the 6 critical regulatory bodies that are participating in the development of future considerations for an equivalent and reciprocal set of conscript elements of compliance to GMP conditions of operation.
This coupled with the leveraging of qualified registrars to perform such audits solves the question of the logistics in the favor of all regulated manufacturing. Numbers show that a risk-based approach to an audit plan of less than 3% of manufacturing is the dilemma. If this means more acceptance with conformance standards that come closer to the QSR approach then the trade-off is a win-win for regulators and conformance bodies.
Areas Covered in the Session :
- An explanation regarding the design and execution of MDSAP
- The status of the program
- What is the anticipated plan for MDSAP on a 2-3-year horizon?
- Why it makes sense to have growth-risk-based QMS to meet QSR requirements for GMP
- What an export program from the US means and how it comes back to GMP controls
- Auditors? Internal, external, independent, and others who qualify this program
- Status as of 2018 in participation, shortages to the program and planning forums
- Interactive Q&A Session
Who Should Attend:
- Directors/VPs of Quality
- Quality GxP Decision Makers
- Marketing Managers of Regulated Business in GMP
- CMO leadership
- VPs/Directors of Manufacturing
- Directors of Engineering and R&D
- New Business Ownership of approved devices
- Educational Business Leadership for new MD startups
- Managers and Supervisors of Quality, Regulatory, Engineering and R&D Departments, who should have knowledge of MDSAP
Course Director: WALTER E. MURRAY
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