EVENT DETAILS
March 18-20, 2008
Novatek International and IPA, Environmental Monitoring in Pharmaceutical Manufacturing (Seminar and Workshop)
Novatek International and International Pharmaceutical Academy (IPA) have joined together to bring you Environmental Monitoring in Pharmaceutical Manufacturing seminar taking place from March 18 to 20, 2008 in New Jersey, USA. We are delighted to invite you to participate in this event. Join us for a comprehensive seminar & workshop focusing on the newest issues and guidelines on Environmental Monitoring.
Topics include:
· GMP requirements for environmental monitoring (EU, US 21CFR)
· Cleanroom Testing and Monitoring
· Microbiology of Environmental Monitoring
· Environmental Monitoring in Non-Sterile Manufacturing
· Applying a Risk Approach to Environmental Control Issues
· Designing and Implementing an Effective Cleaning and Disinfection Program
· Risk Based Approach to Environmental Monitoring
· Components of the Cleaning Validation Protocol
· Statistics for Cleanroom Testing and Monitoring
· Cleanroom Monitoring in Compliance with ISO 14644-1 (ISO 14644-2)
· Airborne Particle Count Testing
· Troubleshooting Microbial Excursions in Pharmaceutical and Biotech Facilities
· Statistics for Cleanroom Testing
· Electronic Environmental Monitoring Data Management System
· Addressing Out-of-Specification (OOS) Events and Excursions
· Conducting Root Cause Analysis and CAPA in Environmental Monitoring
· Auditing of Aseptic Processing Operations
· GMP and Quality System Regulations for Water Systems
· Comparison of Water Purification Techniques
Distinguished Speakers include:
Dr. Frank S. Kohn; President of FSK Associates (retired Director of Manufacturing for Wyeth), Susan Cleary; Associate Director of Product Development, Novatek International. Dr. Ken Goldstein; Cleanroom Consultants Inc., Mr. Jeffrey Okun; Siemens Water Technologies; Mr. Jim Polarine, Steris corporation, Mr. Kenneth Christie, VP, VTS consultants ; and More.
To find out more and to register for the seminar please visit : http://ipacanada.com/em_nj08.html
|
