Develop, Execute and Enforce an Effective Validation Master Plan

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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