Nova-Seminars

Presents the first joint conference on

The Environmental Monitoring Technical Seminar and Workshop

and

The Stability Technical Seminar and Workshop

September 28^th-30^th, 2005

San Francisco, USA

A comprehensive technical seminar & workshop, focusing on the newest issues and guidelines for Environmental Monitoring, Stability, and Compliance.

Distinguished Speakers: 

(Environmental Monitoring) Dr. Kenneth H. Muhvich, Micro-Reliance LLC (former FDA Review Microbiologist); Andre Ponomarev, Executive Vice President Genpharm “Merck KGa A” (former Health Canada Inspector); Ziva Abraham, Microrite Inc; Dr. Frank S. Kohn, Pres. of FSK Associates (retired Director of Manufacturing for Wyeth); Bob Livingston, Pres. of Arion Water, Inc; Michael O'Grady, Sr. Product Mgr. for Microbiology and Special Analytics at EMD Chemicals Inc. 

(Stability) Dr. Christopher Smith, Vice President Quality, aaiPharma Inc. (former FDA, Assistant Director); John O’Neil, MS, Manager of Stability, Sanofi-Aventis; Michael D. Barron, MBA, Director of Stability, Cardinal Health; Anthony Barcia, Corporate Quality and Compliance, world wide, Johnson and Johnson; Carla Crowley, LIMS Administrator, Baxter Healthcare; Susan Cleary, Assoc. Dir. of Product Development, Novatek International.

Regulatory Topics include: = “ Inspectional issues for Quality, Microbiology and Production Departments” = “Globalization and Compliance to Multiple Regulations” = “FDA Requirements for a 21 CFR Part 11 Compliant computerized System”

Environmental Monitoring Topics include: = “Reacting to Environmental Monitoring Excursions” = Environmental Monitoring, “A Complex System Simplified” = “Strategies for Establishing a Risk Based Approach to Environmental Monitoring” = “High Purity Water Systems, Improved Design and PAT Approaches to Improve Water Quality and Reduce Testing Costs” = “The Qualification and Comparison of Microbial Air Samplers” = “FDA Requirements for a 21 CFR Part 11 Compliant Environmental Monitoring System” and more.   

Stability Topics include: = “Risk Management for Stability Operations” = “Achieving Mistake proof Stability Storage Operations” = “IN USE/OPEN PACKAGE” = “Cleaning Validation” = “Implementing a Stability program” = “Surviving an FDA inspection” = “High Purity Water Systems, Improved Design and PAT Approaches to Improve Water Quality and Reduce Testing Costs” = “FDA Requirements for a 21 CFR Part 11 Compliant Stability System” and more.

 Sponsored by:

Novatek International and EMD Chemicals, Inc

Held at:

Hilton San Francisco -333 O’Farrell Street, San Francisco, California, USA 94102

Networking Event: San Francisco Cruise!

Join us on the evening of September 29^th at the San Francisco harbor, for a three hour San Francisco Cruise buffet Dinner and Open Bar.

For more information, please call 514-788-6023 or visit our web site at:

www.novaseminars.com