The Environmental Monitoring Technical Seminar and Workshop

Venue: Hilton San Francisco

Location: San Francisco, California, United States

Event Date/Time: Sep 28, 2005 End Date/Time: Sep 30, 2005
Early Registration Date: Sep 01, 2006
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Description

Nova Seminars

Presents the first joint conference on

The Environmental Monitoring Technical Seminar and Workshop

and

The Stability Technical Seminar and Workshop

September 28th-30th, 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 29th 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

Venue

333 O’Farrell Street
California
United States
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