Event Date/Time: Sep 06, 2004 End Date/Time: Sep 08, 2004
Early Registration Date: Jun 30, 2004
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8 Key Case Study Presentations, including:

Stewart Green, Director of Quality Assurance, WYETH PHARMACEUTICALS
Mark Gorzkiewicz, Engineering Support Manager, AVENTIS
Tim Eaton, Sterile Manufacturing Specialist, ASTRAZENECA
Claire Noble, QA Manager, Aseptic Services, CLINOVIA
Dr Monika Sauter, Consultant Microbiologist, PLIVA
Mike Baker, Quality Systems Manager, ASTRAZENECA
Robert Johnson, PLIVA
Tony Byrne, Technical Services Manager, ORGANON

Benefits of attending:

• Gaining Sterility Assurance, achieving compliance and cost savings
• Explore different media fill challenges
• Investigate available test methodologies to improve filtration performance
• Understanding and meeting the challenges of ISO 14644 and ISO 14698
• Managing the differences between the FDA expectations and annex 1
• Developing cost effective and responsive validation procedures
• Risk Assessment for critical areas and approaches to risk management
• Methods for dealing with failure and out of limits results
• Gain the latest updates on the “Yellow Guide” for isolators
• Understanding the ISPE baseline guide for design of a biotech facility
• Operational practicalities, maintenance aspects and economic considerations for Integrating a new sterilisation filling line

Day Three Interactive Workshop * Wednesday 8th September

New ISO Cleanroom & Contamination Control Standards

Designed to prepare senior pharmaceutical professionals for the transition to new operations and the implications for existing processes and procedures. This workshop explains the work of the ISO Technical Committee 209 and reviews some of their key documents, providing participants with a full understanding of the EN/ISO 14644 & 14698 family of standards.


Additional Information

EARLY BIRD REGISTRATION DISCOUNTS! Register before 30th June 2004 and receive a discount from the registration fee. NHS and Academic discounts - Half price registration for UK Hospital and University staff.