Event Date/Time: May 29, 2006 End Date/Time: May 30, 2006
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Description

AN IMPORTANT TWO-DAY COMPREHENSIVE & INTERACTIVE COURSE, CASE STUDIES & WORKSHOPS ON:

- Regulatory Aspects of Cleaning Validation Across Pharmaceutical, Biotech and Biological Manufacturing
- Review of FDA 483’s on Cleaning Validation
- Regulatory Requirements
- Current Cleaning Validation Industry Trends
- Updating your current Cleaning Validation Program
- Sterilization process descriptions and options
- HVAC Sanitization and Cleaning Control
- Equipment and Apparatus Cleaning Validation
- Post Validation and routine process control
- Sampling Methods, Planning, and Testing
- Determination of proper swab technique
- Selection of Most Suitable Analytical Method/s
- Selection of appropriate cleaning agents
- Establishing Residue Limits and Acceptance Criteria
- Execution and results interpretation
- Validation of GMP Washers for Automated Cleaning
- Designing a successful Cleaning Validation Master Plan
- Writing validation SOPs, Master Plans & Protocols, Reports

Distinguished Course Leaders:
Steven A. Weitzel - Critical Process Cleaning, Inc.
Nancy E. Tomoney - PharmaSys, Inc.
Julie Anderson - PharmaSys, Inc.

Who Should Attend?

- Validation
- Cleaning
- Method Development
- Quality and Compliance
- Regulatory Affairs
- Quality Control
- Corporate Officers
- Research and Development Personnel Involved with GMPs
- Production
- Raw Materials Testing
- Product Development
- Formulation
- Manufacturing
- Quality Assurance
- GMP/GLP Compliance
- Pre-Clinical Research
- Product Submission
- Training
- Documentation and Technical Writing
- Contract Laboratories
- Consultants
- Contract manufacturing

Venue

5875 Airport Road
Mississauga
Ont. L4V 1N1
Canada
MORE INFO ON THIS VENUE

Additional Information

- Multiple Registrations: Send five attendees and the sixth is FREE! - Register early. Payments received by April 30, 2006 will be given a 10% discount. - Full - Time Students/Academic (1/2 price)

Types