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5th Annual Stability and Environmental Monitoring Technical Seminar and Workshop

Released on = March 13, 2006, 1:49 pm

Press Release Author = Mike Rozbih

Industry = Pharmaceuticals

Press Release Summary = A comprehensive technical seminar & workshop focusing on the
newest industry trends and current FDA guidelines, requirements and expectations on
Environmental Monitoring and Stability

Press Release Body = sponsored by: Novatek International and EMD Chemicals, Inc and
Held at: New York Marriott East Side; 525 Lexington Avenue, New York City, New York
10017 USA May 3rd- 5th, 2006.Under this umbrella, a variety of topics will be
presented with the goal being to keep the content current and fresh, thus providing
for a unique, educational experience for both first time and regular attendees.
Distinguished speakers will include: Dr. Frank S. Kohn (a former director at Wyeth);
Dr. Kenneth Muhvich (a former FDA review Microbiologist); Mr. Christopher Smith
(Vice President of Quality, aaiPharma Inc., former FDA Assistant Director); Mr. John
O\'Neill (Manager of Stability, Sanofi-Aventis); Ms. Jeanne Moldenhauer (Vectech
Pharmaceutical Consultants, Inc.) along with several other experts who will be
presenting on various industry specific topics. This will provide attendees with the
opportunity to engage in a comprehensive and hands-on three day conference amongst
their peers.

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\",\"Surviving an FDA
inspection\".

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\", \"Bacterial
Identification in Environmental Monitoring\", \"The Qualification and Comparison of
Microbial Air Samplers\", \"FDA Requirements for a 21 CFR Part 11 Compliant
Environmental Monitoring System\".

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\".

Please don’t hesitate to contact Mike Rozbih at (514) 377-7337 or
Mike.Rozbih@ntint.com for further information in regards to this event and VIP
passes.

As a token of our appreciation, a Free Admission to the 3 Hour New York City Cruise
will be included for all registrations received before April 8th, 2006


Web Site = http://

Contact Details = Mike Rozbih
Manager, Marketing
Novatek International
Tel: (514) 337-7337
Fax: (514) 336-6537
E-mail: Mike.Rozbih@ntint.com

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