The Environmental Monitoring and The Stability Technical Seminar and Workshop
Montreal, Canada - March, 2006
May 3rd - 5th, 2006
New York, NY, USA
An event focusing on the newest issues and guidelines on Environmental monitoring, Stability, and Compliance
Novatek International is proud to sponsor Nova Seminars in organizing various technical seminars and workshops in an effort to better serve the industry.
For the year 2006, we plan on holding several events worldwide in order to provide participants with an exceptionally innovative and educational experience. Content will be focused on issues pertaining to FDA Regulations, Environmental Monitoring, and Stability studies. 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.
Therefore, we are delighted to invite you to participate in our 2006 event; Nova Seminar's first joint Environmental Monitoring and Stability Technical Seminar and Workshop, taking place on Wednesday May 3rd to Friday May 5th, in magnificent New York.
The focus of this seminar will be on Environmental Monitoring and Stability trends, as well as current FDA guidelines, requirements and expectations.
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); 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.
As a token of our appreciation, a Free Admission to the 3 Hour New York Cruise will be included for all registrations received before April 1st, 2006.
Distinguished Speakers:
Environmental Monitoring:
Dr. Kenneth H. Muhvich, Micro-Reliance LLC (former FDA Review Microbiologist)
Karen Parker, Former Vice President, King Pharma
Ziva Abraham, Microrite Inc
Dr. Frank S. Kohn, President of FSK Associates (former Director of Manufacturing for Wyeth)
Jeanne Mauldenhauer, Vectech Pharmaceutical Consultants, Inc., USA
Michael O'Grady, Sr. Product Mgr. for Microbiology and Special Analytics at EMD Chemicals Inc.
Stability:
Christopher Smith, Vice President of Quality, aaiPharma Inc. (former FDA Assistant Director)
John O'Neill, MS, Manager of Pharmaceutical Stability Services, Sanofi-Aventis
Michael D. Barron, MBA, Director of Pharmaceutical Stability Services, Cardinal Health
Anthony Barcia, Corporate Quality and Compliance World wide, Johnson & Johnson
Susan Cleary, Associate Director of Product Development, Novatek International.
TOPICS: 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:
"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"
"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"
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"
Sponsored by: Novatek International and EMD Chemicals, Inc.
Held at: New York Mariott East side Hotel, 140 East 49th street, New York, USA 10017
Networking Event: New York Cruise!
Join us on the evening of May 4th at the New York harbor, for a three hour New York Cruise Buffet Dinner and Open Bar.
For more information regarding seminars or to register, please visit: www.novaseminars.com, or call 514-421-2937.
May, 2008 Cotentin Imports and Novatek.
Novatek International, the pioneer of 21 CFR Part 11 compliant LIMS, is pleased to announce the appointment of Cotentin Imports as its representative partner in South Africa.
