Product category:
Environmental contamination, noise, dust and fume extraction, sensors
News Release from: Novatek International | Subject: Environmental Monitoring and Stability guideliness
Edited by the Manufacturingtalk Editorial
Team on 15 March 2006
Environmental Monitoring and Stability
guideliness
Novatek offers a comprehensive technical seminar and workshop on the newest industry trends and current FDA guidelines, requirements and expectations on Environmental Monitoring and Stability.
Novatek offers a comprehensive technical seminar and workshop on the newest industry trends and current FDA guidelines, requirements and expectations on Environmental Monitoring and Stability 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
This article was originally published on Manufacturingtalk on 11 Aug 2006 at 8.00am (UK)
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Novatek International has announced the latest version of its standardised Environmental Monitoring software solution EM version 2.1.
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The Raw Materials Analyzer is a unique 21 CFR Part 11 compliant software program that is designed to facilitate the testing of incoming raw materials and packaging components.
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 , former FDA Assistant Director); Mr John O'Neill (Manager of Stability, Sanofi-Aventis); Ms Jeanne Moldenhauer (Vectech Pharmaceutical Consultants) 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".
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