Event Date/Time: May 22, 2006 End Date/Time: May 23, 2006
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Description

A TWO-DAY COMPREHENSIVE & INTERACTIVE COURSE & WORKSHOPS ON:

- Guidance from FDA, Health Canada , EMEA, ICH, WHO
- Types of Contamination
- Choice of the Cleaning Process
- Effect of Cleaning Agent on Equipment
- Potential interference in analysis of the cleaning process by the cleaning agent
- Selection of sampling method for cleaning samples
- Choice of test method for product and cleaning agent
- Defining Acceptance Criteria
- Bioburden/pyroburden considerations
- Potency and toxicity of the drug
- Method of cleaning
- Materials of Construction
- Water solubility effects
- Cleaning Standard
- The Cleaning Process
- Solution and rinse sampling
- Swabbing
- Sampling Sites
- Pre-Validation Development Studies
- Bioburden – Biological
- Setting Up Engineering Studies
- Maintaining a validated state for drug, biologic and vaccine products
- Microbial Cleaning Validations
- Cleaning for Sterility and Pyroburden

Distinguished Course Leader:
Nancy E. Tomoney - PharmaSys, Inc.

Who Should Attend?
This two day seminar and workshops is directed toward Directors, Managers, Supervisors, Analysts, and Associates in the Pharmaceutical, Biotechnology, Vitamin, Herbal, and allied industries with daily responsibilities in the following areas:

- Cleaning Validation
- Quality Assurance
- Quality Control
- Analytical R&D
- Manufacturing
- Validation Engineers
- Product Development
- Raw Materials R&D
- GMP/GLP Compliance
- Pre-Clinical Research
- Regulatory Affairs
- Formulation
- Calibration
- Product Submission
- Documentation and Technical Writing
- Training
- Production
- Contract Laboratories
- Contract Manufacturing
- Consultants

Venue

Additional Information

hen your organization sends 5 attendees, the 6th is free.

Types