World Conference Calendar

33818 Conferences

Master Verification and Validation Planning to Meet US FDA, ISO 13485 and 14971:2009 Requirements - Webinar by GlobalCompliancePanel

Added by davidross759 on 2010-09-16

Conference Dates:

Start Date Start Date: 2010-10-19
Last Date Last Day: 2010-10-19

Conference Contact Info:

Contact Person Contact Person: Webinars
Email Email:
Address Address: Online Training Webinar, Online, DE, 19801, United States
Phone Tel: 800-447-9407
Phone Fax: 302-288-6884

Conference Description:

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.
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