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

Venue: Toronto

Location: Toronto, Ontario, Canada

Event Date/Time: Mar 03, 2008 End Date/Time: Mar 04, 2008
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Description

Best Practices for Managing Validation Activities

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

Toronto
Toronto
Ontario
Canada
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Additional Information

Who should attend? This interactive course provides attendees, with the knowledge and skills needed to prepare a comprehensive Validation Master Plan (VMP) in order to be in compliance with regulatory requirements. It is intended for Pharmaceutical, Biotech, Medical Device and allied industries’ professionals with responsibilities in the following areas: - Validation - Quality Assurance - Quality Control - Facilities - Cleaning - Engineering - Manufacturing - Process Development - Change Control - Training - Documentation and Technical Writing - Compliance Auditing - Analytical Laboratories - Contract Services - Regulatory Affairs - GXPs

Types