The Environmental Monitoring & Stability Technical Seminars and Workshops
|Event Date/Time: May 03, 2006||End Date/Time: May 05, 2006|
|Registration Date: Apr 24, 2006|
|Early Registration Date: Mar 01, 2006|
Presents the sexond joint conference on
The Environmental Monitoring Technical Seminar and Workshop
The Stability Technical Seminar and WorkshopOrganizer: Nova Seminars
Name of the event:
Environmental Monitoring and Stability Technical Seminars and Workshops
Wednesday May 3rd to Friday May 5th, 2006
8:30 a.m. to 4:30 p.m.
New York Marriott East Side Hotel; New York City, NY
Microbiologists, QA & QC Scientists, Pharmaceutical Industry
Number of attendees: 140
• Nova Seminars’ Certificate of Attendance
• CCM Certificate (18 CEUs)
• EMD Chemicals
• Novatek International
• Canadian College of Microbiology
New York Cruise
Date & Time: Thursday, May 4th, 6:30 p.m. to 9:30 p.m.
• Dr. Kenneth H. Muhvich, Micro-Reliance LLC (former FDA Review Microbiologist)
• Jeanne Moldenhauer, Vectech Pharmaceutical Consultants, Inc., USA
• Karen Parker, Parker Consulting, Former V.P, King Pharmaceuticals
• Ziva Abraham, Microrite Inc
• Dr. Frank S. Kohn, President of FSK Associates (former Director of Manufacturing for Wyeth)
• Michael O'Grady, Sr. Product Mgr. for Microbiology and Special Analytics with EMD Chemicals Inc.
• Mr. Christopher Smith, Vice President of Quality, aaiPharma Inc. (former FDA Assistant Director)
• John O'Neill, MS, Manager of Stability, 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, Assoc. Director 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"
• “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"