Design, Development, and Implementation of a Validation Master Plan (VMP)

Venue: Montreal

Location: Montreal, Canada

Event Date/Time: Sep 18, 2008 End Date/Time: Sep 19, 2008
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Description

A One and Half Day Comprehensive and Interactive Course with Workshops and Discussions on:

- Understanding the Purpose and Scope of the VMP
- Key Elements of Validation
- Regulatory Expectations & Industry Practices
- EU, ICH, FDA and other Regulatory Guidelines
- Defining What to Validate
- Performing DQ/ IQ/OQ/PQ
- Effective Validation Protocols
- Format and Structure of the VMP
- Establishing Validation Policy
- URS, FAT, SAT
- VMP “Project” Flow and Management
- Organizing Systems and Tasks-Hierarchy of Plans
- Organizing needed documentation
- Preparation, review, and release of Validation Master Plan
- Organizational Roles and Responsibilities
- GxP criticality assessment
- Developing a Validation Strategy
- Acceptance criteria
- Standard operating procedures
- Maintaining a Validated State and Revalidation
- Release and Effective Execution of the VMP
- Data Reporting and Data Analysis Techniques

Venue

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