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Disclaimer: The events found at this site are provided solely as a service to our visitors. The listing of these events does not constitute an endorsement of these organizations or their programs by Eisner Safety Consultants, and none should be inferred. Eisner Safety Consultants is not responsible for the content of the Web pages found through these links.U
Audio Conference Understanding the Principles and Pitfalls of 510k Submissions
Rebecca K. Pine Senior RA/QA Consultant Eisner Safety Consultants
Thursday May 28th, 2008 11:30am - 12:30pm EST
Special Eisner Safety Consultant Registration US $99 (Save $150) Enter Promo Code: ac20080508esi
Register for this audio conference
Obtaining premarket clearance for medical devices can be a challenging task. However, it is somewhat less daunting when you start out with a solid understanding of what is expected by the FDA and how the review process works. This audio conference will provide an understanding of the technical requirements of 510k submissions, provide practical advice on preparation of the documents and give an overview of the options and strategies associated with obtaining premarket clearance for medical devices. The speaker will also draw on her extensive experience to provide valuable insights for minimizing the pitfalls and common mistakes associated with these types of FDA submissions. This audio conference will address:
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***************************************************************************************************************************************************** May 5-9, 2008: AAMI Course: Radiation Sterilization for Medical Devices; Atlanta, GA www.aami.org May 12-14, 2008: AAMI Course: Integrating Risk Management into the Quality System; New Orleans, LA www.aami.org May 31-Jun 2, 2008: AAMI Annual Conference and Expo; San Jose, CA www.aami.org June 2-4, 2008: AAMI Course: Corrective and Preventive Actions Requirements and Industry Practice; Arlington, VA www.aami.org June 9-11, 2008: AAMI Course: Design Control Requirements and Industry Practice; Chicago, IL www.aami.org June 16-19, 2008: AAMI Course: Quality System Requirements and Industry Practice; Denver, CO www.aami.org June 20, 2008: AAMI Quality System Requirements and Industry Practice Exam; Denver, Co www.aami.org June 23-25, 2008: Meetings of the 2008 AAMI Sterilization Committee, affiliated WG's and sub-TAGs ; Arlington, VA www.aami.org Sept 22-25, 2008: AAMI Course: Quality System Requirements and Industry Practice; San Diego, CA www.aami.org Sept 26, 2008: AAMI Quality System Requirements and Industry Practice Exam; San Diego, CA www.aami.org Oct 1-3, 2008: AAMI Course: Integrating Risk Management into the Quality System; Arlington, VA www.aami.org Oct 13-16, 2008: AAMI Course: Industrial Sterilization for Medical Devices; Arlington, VA www.aami.org Oct 20-22, 2008: AAMI New Course: Ethylene Oxide Sterilization for Medical Devices; Arlington, VA www.aami.org Oct 20-22, 2008: AAMI Course: Quality System Requirements and Industry Practice; London, UK www.aami.org Oct 24, 2008: AAMI Quality System Requirements and Industry Practice Exam; London, UK www.aami.org Oct 27-29, 2008: AAMI Course: Process Validation Requirements and Industry Practice; Phoenix, AZ www.aami.org Nov 3-5, 2008: AAMI Course: Building a Quality Management System in a Regulated Environment: A 13485 Workshop; San Diego, CA www.aami.org Nov 3-5, 2008: AAMI Course: Software Validation Requirements and Industry Practice; Las Vegas, NV www.aami.org Nov 10-13, 2008: AAMI Course: Radiation Sterilization for Medical Devices ; Arlington, VA www.aami.org Dec 1-3, 2008: AAMI Course: Design Control and Requirements and Industry Practice; San Diego, CA www.aami.org Dec 8-11, 2008: AAMI Course: Quality System Requirements and Industry Practice; Arlington, VA www.aami.org Dec 12, 2008:AAMI Quality System Requirements and Industry Practice Exam; Arlington, VA www.aami.org
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