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