Event Detail
IVT's Pharmaceutical Water Systems Forum
September 23 - 24, 2009
- Philadelphia PA UNITED STATES
Center for Business Intelligence
Develop, Validate and Monitor Pharmaceutical Water to Prevent Contamination and Avoid Remedial Actions Audience: Senior Director, Director and Manager level with Titles/Responsibilities in Sterility Assurance, QA/QC, Stability, Microbiology, Chemistry, R&D, Technical Management, Environmental Monitoring, Process Development, Product Development, Validation, Manufacturing, Facilities, Regulatory Affairs Whether used as an excipient for reconstitution of products, during production of the finished product or as a cleaning agent for rinsing vessels, equipment, etc., significant variances in acceptable standards and procedures used for monitoring and controlling quality exist within the BioPharma and Medical Device communities. This conference is designed to help those responsible for developing, validating and monitoring pharmaceutical water, the number one raw material in the industry, to do their jobs better. Topics to be addressed include: I. FDA and Compendial Requirements for Pharmaceutical Water Systems Inspection guides from FDA Highlight differences between different jurisdictions between US companies – European inspection Harmonization of requirements with US, Europe and Japan (European Pharmaceutical Inspection Convention Services (PICS) II. Testing and Validation How do you set alert limits, test, sanitize systems, build new systems, and manage changing chemical requirements? III. Microbiology Microbial specifications Rapid Micro (e.g. Wet chemical testing has been dropped, Online testing – new approach -Cutting down time it takes to receive test results IV. Hot Topics and Controversial Issues Controversy on generating water for injection -Validating reverse osmosis systems (what would it take?) What type of water do you use in medical device production? (Pure steam, clean steam)