Marie Dorat, CQA,CAA is a QA/RA compliance, GxP Training and International product registration Consultant with 17 years experience, in the Pharmaceutical/Medical Device & IVD Industry She also is the CEO of IPRF, LLC which specializes in helping established and start-up companies, develop compliant Quality Systems; Read more
This webinar will provide all medical device companies with a step by step process on how to develop a validation master plan (VMP) for product/equipment transfer, facilities, or to develop a company standard. It will also provide a detailed insight on the best practices for developing and implementing a good plan detailing responsibilities, and deliverables to make validation efficient, and consistent.
Course Objectives:
Attend this webinar to learn in detail how to develop a VMP and the best Practices. The Validation Master Plan describes the way an organization approaches validation; who controls the various aspects of the validation activities. How production, quality, and management will be involved. The VMP also details the validation requirements for each test/ system/ equipment and will guide the organization in achieving its objectives. This webinar will help you understand why the VMP is a project management tool and why it’s a living, breathing document.
Course Outline:
This presentation aims at providing the participants a better insight on:
• What is a VMP and how is it valuable to my company?
• What topics are covered in the VMP and to what extent?
• FDA’s expectations with validation master plans
• How is the VMP controlled and updated?
• How is the VMP implemented?
• Who contributes to the VMP?
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Quality Assurance
• Regulatory Affairs
• Operations
• Engineers
• Quality Engineer
• QA/QC Professionals
• Engineering/Technical Service Professionals
• Consultants
• Operations and Manufacturing
• Compliance Professionals
Write it Right – Well Written Procedures are Essential for QMS Effectiveness
LIVE : Scheduled on
17-January-2025 :01:00 PM EST
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FDA Audit Best Practices - Dos and Don'ts
LIVE : Scheduled on
24-January-2025 :01:00 PM EST
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