The Environmental Monitoring & Stability Technical Seminars and Workshops

Venue: New York Marriott East Side Hotel

Location: New York City, New York, United States

Event Date/Time: May 03, 2006 End Date/Time: May 05, 2006
Registration Date: Apr 24, 2006
Early Registration Date: Mar 01, 2006
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Description

Nova Seminars

Presents the sexond joint conference on

The Environmental Monitoring Technical Seminar and Workshop

and

The Stability Technical Seminar and WorkshopOrganizer: Nova Seminars

Name of the event:

Environmental Monitoring and Stability Technical Seminars and Workshops

Date:

Wednesday May 3rd to Friday May 5th, 2006

Time:

8:30 a.m. to 4:30 p.m.

Location:

New York Marriott East Side Hotel; New York City, NY

Targeted Audience:

Microbiologists, QA & QC Scientists, Pharmaceutical Industry

Number of attendees: 140

Certificates:

• Nova Seminars’ Certificate of Attendance
• CCM Certificate (18 CEUs)

Sponsors:

• EMD Chemicals
• Novatek International
• Canadian College of Microbiology

Networking Event:

New York Cruise
Date & Time: Thursday, May 4th, 6:30 p.m. to 9:30 p.m.

Distinguished Speakers:

Environmental Monitoring:
• 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.

Stability:
• 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.

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:
• "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"

Venue