Medical Device Single Audit Program (MDSAP)

$299.00

Description:

Every regulatory and quality professional working for a medical device company should attend this webinar to understand MDSAP objectives, MDSAP advantages and disadvantages and its implications for medical device companies.

In 2017, all medical device companies operating globally will be impacted by MDSAP and need to get start getting ready for it now.

In October 2011, the International Medical Device Regulators Forum (IMPDF) was created as a replacement of the Global Harmonization Task Force on Medical Devices (GHTF). IMPDF is a voluntary group of medical device regulators from around the world who wants to accelerate the international medical device regulatory harmonization and convergence. In 2012, the Medical Device Single Audit Program (MDSAP) Working Group was created to develop specific documents for advancing the concept of the Medical Device Single Audit Program.

The main goal of the MDSAP is to provide a more effective, efficient and less burdensome regulatory oversight of the quality management systems of medical device manufacturers. The implementation of the MDSAP is intended to allow for a single audit that will satisfy the regulatory requirements of FDA, TGA, Health Canada and Anvisa.

MDSAP includes the use of third party auditors in addition to the regulatory inspectorates. MDASP pilot program started in January 2014 and medical device companies can participate into it on voluntary basis till 2016. After that it will be fully implemented

Areas to be Covered:

What is MDSAP
IMDRF Overview
MDSAP Objectives
MDSAP members
MDSAP Pilot Audit Process
MDSAP Advantages and Disadvantages
MDSAP implementation timelines

Who will Benefit:

This webinar will provide valuable assistance to regulatory affairs and quality professionals working for or with medical device companies. Professionals who will benefit from this training are in:
Senior Management
Middle Management
Manufacturing
Operations
Consultants
Quality Assurance
Regulatory Affairs
Documentation Department
Quality Auditors
Auditing Organizations

Suzan S. Davis

Suzan S. Davis is the President and CEO of Global Regulatory Partners-LLC that provides regulatory affairs, quality, safety and quality services to life science companies.

Suzan has 24 years of experience working in regulatory affairs and quality assurance assisting many biotech, pharmaceuticals and medical device companies such as Olympus, Smith and Nephew, Pfizer, EMD Sereno, Genzyme and GSK, register their medical devices in US and outside US and also implement and maintain their quality system properly.

During her career, Suzan prepared and submitted many 510(K), PMAs and design dossiers for CE marking. She has also conducted many ISO 13485 and quality system audits for multiple medical device companies in US, EU, Latam and Asia. She helped many medical device companies implement the appropriate quality systems and be in compliance with FDA and ISO 13485 requirements.

Suzan Davis has a Pharm.D from Pharmacy college in Paris, a Master in Regulatory Affairs and an MBA from Northeastern University in Boston. She is also a certified quality auditor by ASQ.

$299.00

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance