ComplianceOnline

Develop, Execute and Enforce an Effective Validation Master Plan

Instructor: David Dills
Product ID: 700910
  • Duration: 60 Min

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Jun-2008

Training CD / USB Drive

$500.00
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(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

Understand why the VMP is a project management tool and why it’s a living, breathing document.

Description

This webinar will provide valuable assistance and guidance to all life sciences manufacturers that are preparing to use or are currently using validation master plans to bullet-proof their validation programs.

The VMP is a document that has never been mandatory, but can be one of the first documents a regulator will ask to view but most companies are using them. This is an extremely important document, mainly because in constructing it, many serious commitments and decisions have to be made. Validation Master Plans or also known as Master Validation Plans are basically a road map (game plan) identifying who, what, when, where, how and why with your validation programs. It can be defined as a documented plan that describes the policy, philosophy, strategy, and methodology for validating a site, process, system or product. The plan can be used as an executive summary within the company to introduce new personnel to a validation project and as the starting point for a validation gap assessment or audit. The plan can contain or will reference project schedules, project priority status, responsible individuals, project descriptions, etc. A plan can certainly help with the following: underestimating the number of validation tasks, limited resources, undefined responsibilities and confusion during start-up and testing, poorly defined philosophies and approaches, lack of priorities, lack of communication, and lack of management support.

Areas Covered in the seminar:

  • Basic elements (table of contents) of plans being used including scope of validation activities, objectives, review, roles and responsibilities, schedules, etc.
  • FDA’s expectations with validation master plans.
  • Who is the system owner for maintaining the integrity and updating of the VMP.
  • What should a VMP address and cover and best practices.
  • Learn the different approaches and tactics being applied for validation master planning.
  • Recent enforcement actions taken against firms using these plans.
  • Prospective, concurrent and retrospective plans and use of many templates.
  • Understand why the VMP is a project management tool and why it’s a living, breathing document.

Who will benefit:

This webinar will provide valuable assistance and guidance to all life sciences manufacturers that are preparing to use or are currently using validation master plans to bullet-proof their validation programs and make them effective and ensure that things get done in a timely manner. The employees who will benefit include:

  • All levels of Management for all departments and those who desire a better understanding
  • QA/QC/Compliance/Regulatory Affairs
  • Engineering/Technical Services
  • Consultants
  • Operations and Manufacturing

Instructor Profile:

David R. Dills, Senior Consultant with PAREXEL Consulting has more than 19 years of hands-on and direct experience in quality, quality systems, regulatory affairs, compliance and validation within the life sciences and FDA regulated industry for all stages of product commercialization and FDA compliance. David has been previously affiliated with well-known manufacturers and service providers and has served in various quality, regulatory and compliance management and advisory capacities. David is global industry speaker and author of technical and compliance related topics published in industry journals. Please refer to his biography provided herein for additional information about his background and areas of expertise.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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