Changes affecting EU GMP and the FDA's CGMP - Environmental Monitoring in Cleanrooms- One Day Seminar and Table Top Exhibition
EU GMP and the FDA’s CGMP set the target cleanliness levels for pharmaceutical cleanrooms. Both documents refer the reader to ISO 14644 for the methods to determine these cleanliness levels. ISO 14644 is currently under revision. Learn how the inappropriate statistical analysis tools in the current document are to be improved and about the new standard for calibration of air particle counters, ISO 21501-4. Learn about the new ISO 14698 for viable contamination in cleanrooms and it is possible impact on EU GMP Annex 1. Learn about practical solutions to address both the viable and non-viable monitoring challenges for pharmaceutical clean rooms.
Programme
9.00am – 9.30am
Registration, Viewing of Exhibition and Coffee
9.30am – 10.30am
Impact on EU-GMP - Tony Harrison – Hach Lange, Vice Chairman - PHSS
• Forthcoming Changes to ISO 14644-1 and 14644-2
• ISO 21501 Calibration of Air Particle Counters
10.30am – 11.15am
Proposed Changes to ISO 14698 for Microbial Sections - Tony Harrison – Hach Lange, Vice Chairman - PHSS
• PHSS Technical Monograph No. 2 – Review
11.15am – 11.35am
Morning Break incl viewing of Exhibition
11.35am – 12.20pm
Bacterial Identification at Genotype Level - Simon McEwen – McEwen Laboratories
12.20pm – 13.30pm
Lunch and Viewing of Exhibition
13.30pm – 14.30pm
Automation of Viable Monitoring and the concept of integrated viable and non-viable particle monitoring systems - David Hall – PMS
14.30pm – 14.45pm
Afternoon Break
14.45pm – 15.45pm
Viable Particle Counting - Joyce Johnson – AstraZeneca
15.45pm – 16.00pm
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Venue
AstraZeneca, Charnwood
Speakers
Tony Harrison - Hach Lange, Vice Chairman, PHSS
Simon McEwen - McEwen Laboratories
David Hall - PMS
Joyce Johnson - AstraZeneca
Date
May 13, 2010
Enquiries
Contact the PHSS Office for more details
Costs
Member £ 300.00 + VAT
Non Member £ 400.00 + VAT
