RAPS pre-approved webinar on "Creating Effective Master Validation Plans" from GlobalCompliancePanel

(prHWY.com) August 24, 2012 - Wilmington, DE -- Description:Among the prime reasons for which new product applications are rejected by the FDA, lack of a comprehensive Validation Master Plan and well-documented validation procedures rate very high. Planning is thus at the root of the documentation procedure that paves the way for FDA approval.
If validation has to be efficient, easy and consistent; it is necessary to establish a good plan that details responsibilities, deliverables, and checkpoints. This and many more important details form the main elements of a Validation Master Plan. The plan will mention which of the staff have access and control to which of the documents.
This webinar will highlight important details relating to a VMP. It will detail the importance of a VMP to the organization. It will teach them how to control and update this document. Participants will understand how to implement the VMP and how to contribute to it.
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When:September 13, 10:00 AM PDT | 01:00 PM EDT
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By whom:
Charles Gyecsek is formerly of Hoffman LA Roche where he worked primarily in Validation, Microbiology, Quality, and Operations. During his career, Charles set-up and managed one of the largest GMP cleanroom facilities in the US, encompassing more than 200 rooms in three separate facilities.

Charles' extensive experience involves plant start-up, cleanroom design and renovation, quality system auditing, regulatory submission writing, microbiology, equipment and cleaning qualification, utility validation, water system design and validation, aseptic processing, risk management, and regulatory inspections and responses.

Charles is currently President of MIJ Enterprises whose Compliance Division provides personalized consulting and training services within FDA regulated industries pertaining to pharmaceuticals, diagnostics, devices, and biotech products. Their core mission is to help clients maximize the benefit of a quality system in order to provide innovative products and exceptional services to their customers.
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For whom:
The webinar will benefit
o QA managers and personnel
o Regulatory affairs
o Operations managers
o Engineers
o Validation professionals
o Training departments
o Consultants
o Quality Engineers
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Duration: 60 minutes
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To enroll for this webinar, contact
webinars@globalcompliancepanel.com
Phone: 800-447-9407

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