Medical Device Single Audit Program (MDSAP) – All You Need To Know
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What is MDSAP and where is it 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 acceptances with conformance standards that come closer to the QSR approach then the trade-off is a win-win for regulators and conformance bodies.
Why Should you Attend
As medical devices become more diverse and sophisticated, the Global Medical Device Regulations governing them are continuously evolving. With a strong understanding of the regulations and requirements in your markets you can more quickly put out innovative products and assist patients who need access to life-saving products and technologies.
This webinar will introduce you to the Medical Device Single Audit Program. You will learn about the scope of the program, how to apply for it, the Authorized Organizations, the rating system that has been developed and what happens when you sign onto the program. The webinar will also cover the audit process. You will discuss how the audits are organized, what to expect during a MDSAP audit and how this differs from a typical certified body audit.
Objectives of the Presentation
- 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
- 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
Instructor Profile:
Walter E. Murray
Walt Murray is the CEO of ARCexperts (Audit/Risk/Compliance), providing expert consulting and training for technical science-based companies. He serves as an independent consultantwith multiple clients in Pharma, Medical Device, IVD and retail consulting on regulated products. He has an extended network of healthcare, software and food & beverage team consultants.
Walt Murray is a management systems (OEHSMS) and regulatory affairs (QA/RA) professional with more than 32 years of experience working with internationally recognized, highly regulated companies in automotive, aerospace, chemical, medical device, biomedical and pharmaceutical sectors. A Six Sigma Black Belt, Walt is certified (CSSMB) in quality and environmental systems auditing (CLA), Critical-Thinking Skills (CTS), Process Control and as a PMO. He also has extensive training and consulting expertise in Quality Event (QEM)/CAPA management, risk management, supplier control and audit management.
Having personally performed more than 350 1st/2nd/3rd-party audits, for a variety of Fortune 500 companies as well as hosted investigational and systems audits by the FDA, Therapeutic Goods Administration (TGA), Medicines and Healthcare Products Regulatory Agency (MHRA) and Health Canada (CMDR) due to vast knowledge of regulation and guidance documentation and quality standards. This includes guidance on the MDSAP process for auditing.
Walt holds a Bachelor of Science degree in analytical chemistry from the University of Richmond, VA and has completed graduate-level coursework at the University of Tennessee, Knoxville (Deming School). He is an active member of the Society of Manufacturing Engineers (SME), the Regulatory Affairs Professional Society (RAPS), the American Society for Quality (ASQ) and the Society for Quality Assurance (SQA). He was the founding Executive Director of the Mfg. Council of the Central Valley of CA.(MCCV).
Walt has assisted in the strategic development of Enterprise Software with validation support in life science companies. He recently lead the quality and compliance consulting services division of MasterControl®, a leading provider of quality management software enterprise to regulated companies worldwide. His broad knowledge base makes him a sought-after speaker at national and international compliance forums. He is a Vietnam Veteran where he served as a corpsman and certified laboratory technologist.
Additional information
| Purchase Options | Live Access, Recorded Access, Training CD/DVD, USB Flash Drive, Live+Recorded Access, Live Access+CD/DVD, Live Access+USB Flash Drive |
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