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| Begins |
September 22, 2008
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| Email |
enquiry@ipacanada.com
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| Category |
Health: Medicine
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| Category 2 |
Health: Professions
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| Category 3 |
Health: Pharmacy
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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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