20 March 2012 -- The Regulatory Affairs Professionals Society (RAPS) will host a webcast tomorrow, 21 March, at 12:00 pm EDT, on effective preapproval inspection preparation for companies seeking Premarket Approval (PMA) from the US Food and Drug Administration (FDA) for Class III medical devices.
In this RAPS Webcast, Preparing for Preapproval Inspections, Michael Ronningen, director, global compliance, Beckman Coulter Inc.; and Edward Kimmelman, regulatory affairs/quality systems consultant, Becker & Associates, Quintiles Consulting and The Anson Group, will discuss how to frame a program to prepare for the rigors of a Preapproval Inspection (PAI) of a manufacturing facility as part of the PMA approval process. They will go through a framework of the program, compliance analysis and process interfaces to identify areas of potential noncompliance risks that can impact product approval.
- Michael Ronningen, director, global compliance, Beckman Coulter Inc.
- Edward Kimmelman, regulatory affairs/quality systems consultant, Becker & Associates, Quintiles Consulting and The Anson Group
90-minute webcast entitled Preparing for Preapproval Inspections
21 March, 12:00–1:30 pm EDT
How to Access:
Members of the working media may request access to this live RAPS webcast or to the recording by contacting Zachary Brousseau, senior manager, communications, RAPS, at email@example.com or +1 301 770 2920, ext. 245.
The Regulatory Affairs Professionals Society (RAPS) is an international membership organization of regulatory professionals in the rapidly growing medical device, pharmaceutical and biotechnology sectors. Regulatory professionals play vital roles in making better healthcare products possible. They work throughout the healthcare product lifecycle, ensuring these products are safe and effective, while driving organizational strategy and sound decision-making. RAPS supports these individuals and the regulatory profession by providing education and training, Regulatory Affairs Certification (RAC), professional standards, research, knowledge-sharing, publications, networking, career development opportunities and other valuable resources; and is committed to helping its members continually develop the knowledge and skills they need to excel. RAPS is headquartered near Washington, DC, with offices in Brussels and Tokyo.