Facility Qualification & Validation

Venue: Four Points by Sheraton Toronto Airport

Location: Mississauga, Ontario, Canada

Event Date/Time: Sep 10, 2007 End Date/Time: Sep 11, 2007
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Description

Facility Qualification & Validation

Strategies for the integration of Commissioning and Validation of Critical Systems into the total management of FDA regulated Facility Projects

A TWO-DAY COMPREHENSIVE & INTERACTIVE COURSE with CASE STUDIES & WORKSHOPS ON:

- Complying with USP, EP and FDA Requirements
- Design Qualification and Review
- Preparing for external and internal audits
- Setting Qualification levels for Equipment and Systems
- Commissioning and Qualification of Critical Utility Systems
- Commissioning and Validation of HVAC Systems
- Design and Commissioning of Pharmaceutical Water Systems
- Equipment Qualification for New and Exisitng Facilities
- Performing Gap Analysis
- Factory Acceptance Testing (FAT)
- Site Acceptance Testing (SAT)
- Change Control Management for Facility Design and Qualification
- Risk Assessment and Risk Management
- Developing the Master Plan for Commissioning and Qualification

Distinguished Course Leaders

Ms. Christina Dell Cioppia
Mr. Ralph W. Donnelly
Mr. David Vincent
Mr. Bob Livingston

Venue

6257 Airport Road
Mississauga
Ontario
Canada
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Additional Information

Who Should Attend: This two day seminar, case studies and workshop series is directed toward Directors, Managers, Supervisors, Analysts, and Associates in the Pharmaceutical, Biotechnology, Medical Device, and allied industries with daily responsibilities in the following areas: Facilities Management Facility Monitoring Validation Engineering Technical Operations Change Control Production Manufacturing Quality Assurance GMP/GLP Compliance Project Management CAPA Coordination Regulatory Affairs Training Documentation and Technical Writing Contract Laboratories Contract manufacturing Registration Fee: $825.00 + GST (6%) EARLY BIRD DISCOUNT 10% discount applies to registrations with payment received by July 30, 2007 25% Discount - for Health Canada and Government Employees, Full Time Students & Academic Faculty