Fremont 2016 Webinar on ISO 13485 and 14971 Requirements
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| Description: | Overview: FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols. How to employ equipment / process DQs, IQs, OQs, and PQs, against a background of limited company resources (personnel, budget, time). A matrix simplifies "as-product", "in-product", process, and equipment, et al, software V&VT, assuring key FDA requirements are not overlooked. The QMS and 21 CFR Part 11 must be considered. Areas Covered in the Session: Verification or Validation - Recent regulatory expectations The Master Validation Plan Product Validation - how it differs from process / equipment V&V Process / Equipment / Facility Validation When and How to use DQ, IQ, OQ, PQ How to use your Risk Management Tools (per ISO 14971) The 11 "must have" elements of software validation 21 CFR Part 11 issues Possible "test case" formats. Who Will Benefit: Senior management, project leaders Regulatory Affairs Quality systems personnel R&D and engineering staff All charged with new product development, regulatory submissions, initiating / overseeing company-wide V&V planning, using a risk-justified approach CAPA and P&PC personnel desiring to verify proposed solutions and minimize post-production / life cycle and other costly problems. Speaker Profile John E Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. Read more at : http://www.compliance4all.com/control/w_product/~product_id=500818LIVE |
| URL: | http://www.compliance4all.com/control/w_product/~product_id=500818LIVE |
| Status: | Deleted |
| Date: | Wednesday, September 28, 2016 |
| Time: | 2:00pm-3:30pm UTC |
| Duration: | 1 hour 30 minutes |
| Access: | Public |
| Category: | Education*, Health*, Webinar* |
| Created by: | compliance4all |
| Updated: | Friday, August 12, 2016 6:56am UTC |
| : | $ 150.00 |
| : | 18004479407 |
| : | support@compliance4All.com |
| : | Event Manager |
| : | 800-447-9407 |
| Comments: | None |