Navigating the New FDA Draft Guidance on ISO 10993: Biological Evaluation of Medical Devices

The webinar will focus on the amendments made to the Blue Book Memorandum #G95-1 Use of International Standards ISO-10993, “Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.” It will help attendees stay updated with the current trends set out by the amendments to the guideline and help them draft guidance documents that will impact their business.

Why Should You Attend:

In April 2013, FDA published a new draft guidance entitled Use of International Standard ISO -10993, “Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.” This guidance is intended to replace the existing Blue Book Memorandum #G95-1 Use of International Standards ISO-10993, “Biological Evaluation of Medical Devices Part 1: Evaluation and Testing” dated May 1, 1995.

Who Will Benefit:

This webinar will benefit the following personnel in the medical device industry:

Regulatory managers

Project managers

Staff involved with regulatory filings

Instructor Profile:

Cheryl Wagoner, has 20 years of experience in quality assurance and regulatory affairs. She currently is the principal consultant/owner of Wagoner Consulting LLC, where she provides consulting services to medical device and pharmaceutical companies. Previously, she has held various positions in quality, regulatory, clinical and compliance in the medical device and pharmaceutical industries.

Note:

Use coupon code 232082 and get 10% off on registration.

For Registration:

http://www.complianceonline.com/navigating-the-new-fda-draft-guidance-on-iso-10993-biological-evaluation-of-medical-devices-webinar-training-703585-prdw?channel=sciencedz