Pharmaceutical Water Systems Design, Validation, Operation & Maintenance

Venue: Toronto, Canada

Location: Toronto, Ontario, Canada

Event Date/Time: Feb 21, 2008 End Date/Time: Feb 22, 2008
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Description

Strategies for Maintaining Regulatory Compliance and Water Quality

A Two-day Comprehensive & Interactive Course, with Workshops on:

- Regulatory requirements for pharmaceutical
water systems
- USP and FDA guidelines for Purified Water
(PW)
- Comparing Purification Techniques for Water
Systems
- Testing Procedures & Requirements
- Equipment and design of pharmaceutical water
systems
- Complying with validation requirements
- Water system design considerations
- Standard Maintenance Procedures (SMPs)
- Achieving a successful validation plan
- IQ, OQ, PQ of water systems
- Preparing validation documentation and SOPs
- Change control and re-validation
- Microbiological concerns for water design
and standards
- Operations and use considerations for your
water program
- Identifying Common Impurities and sources of
contamination
- Pre- and Post-Treatments for water systems
- Identifying appropriate methods to test for
specific contaminants
- Designing, testing and inspecting a water
treatment system
- Identify required qualification and
documents

Venue

Additional Information

Who should attend? This program is for Directors, Managers, Supervisors, Analysts, and Associates in the Pharmaceutical, Biopharmaceutical and allied industries, who have responsibilities involving the following areas: - Engineering - Facility - Validation - Production - Maintenance - Manufacturing - Quality Control - Microbiologists - Quality Assurance - Water Treatment Systems - Water System Suppliers - Compliance Auditing - Change Control - Regulatory Affairs - Training - GXPs - Documentation and Technical Writing - Technical support personnel - Consultants - Contract Services

Types