The Medical Device Single Audit Program (MDSAP) is becoming a viable and time-saving solution for medical device companies seeking to audit against various regulatory authorities’ requirements in one combined review. Many medical device companies plan to participate in the MDSAP in cooperation with the U.S. Federal Drug Administration (FDA). According to www.fda.gov “FDA will continue to accept MDSAP audit reports as a substitute for routine Agency inspections.”
This webinar will explore the issues and benefits that surround the MDSAP and provide insight and conversation into how medical device companies can access the highest level of benefits via the program.
Agenda topics include:
1. Overview and benefits of the MDSAP
2. Who are the members of the MDSAP and who will the program best serve?
3. Requirements for notified bodies qualification
4. How to find more information on the MDSAP
5. How to prepare for the MDSAP
Linda Chatwin, Senior Customer Solutions Consultant, Emergo, a UL Company
Linda Chatwin has been involved with regulated medical products for over 30 years. Through years of watching regulations evolve and change, she has gained a thorough understanding of the global regulatory maze required to bring products to market. She has obtained product approvals for a wide range of products and remains involved in changing requirements for medical devices worldwide.
Chatwin’s regulatory expertise includes US FDA 510(k), 21 CFR Part 11; interoperability and cybersecurity issues; training for QSR, MDR, IVDR, risk management, RoHS and safety standards; writing protocols, obtaining IRB approval and providing oversight of clinical trial for pharmaceutical product development.
Chatwin has navigated many FDA inspections and has negotiated favorable outcomes with FDA. Currently, she assists clients with regulatory issues and challenges, including implementation of UDI processes, product submissions and regulatory road mapping, in-depth training on world-wide regulatory requirements and quality system development and improvement.
Chatwin has spoken at a number of forums, including Regulatory Affairs Professional Society (RAPS), various global industry associations and at a number of FDA public seminars.
Chatwin is an attorney in the U.S. and holds a Regulatory Affairs Certification (RAC).
Alex Butler, Manager of Medical Device Solutions, MasterControl
Alex Butler has a deep understanding of the FDA’s submission process and audit procedures, having navigated several medical devices successfully through market. Butler has written several articles (see “10 Things I Wish I’d Known Before Writing my FDA Response Letter”) and has been interviewed by the media extensively.
He currently serves on BioUtah’s Regulatory, Compliance and Quality Committee. Alex is the lead Product Marketing Manager for MasterControl Registrations, and he’s responsible for developing and/or improving other solutions, including MasterControl Complaints, Bill of Materials (BOM), Projects, Risk, and Supplier Management.
Prior to joining MasterControl, Butler worked as a product development manager for Opal Orthodontics, a division of Ultradent Products Inc., where he helped launch several Class II medical devices, including the Opal Espirit™ Class II Corrector.
The webinar will take place from 1:00-2:30pm ET on October 19, 2017.
All registrants will receive login instructions within 24 hours of the start time. All registrants will receive the recording and slides for the presentations, even if unable to participate live.