Facility Validation & Qualification

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Event Date/Time: Sep 22, 2008 End Date/Time: Sep 23, 2008
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Description

A Two Day Comprehensive & Interactive Course, with Case Studies and Discussions On:

- Complying with Regulatory Requirements and Guidance for Facilities
- FDA and EU Expectations
- How to Integrate Commissioning, Qualification, & Validation Activities
- Performing IQ, OQ, PQ of Facilities Equipment
- Controls and Alarms Verification
- Design Review Procedures for HVAC Systems
- Pharmaceutical Water Systems Design and Commissioning
- Water for Injection Systems (WFI)
- Pure Steam System Validation
- Aseptic vs. Non-Aseptic Cleaning for Facilities
- Change Control of URS, FRS, and Design Specifications
- Performing a cGMP Audit of Facilities and GAP Analysis
- Managing Deviations and Failures
- Applying Risk Assessment and Risk Management

Interactive Sessions and Activities on:

- Planning a Pharmaceutical Facility Renovation
- An FDA Inspection of Facilities
- Preparing a Validation Master Plan
- Performing a Mock Commissioning

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