European Information Network - Ethics in Medicine and Biotechnology
A project of the European Commission,Quality of Life and Management of Living Resources Programme
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European Information Network - Ethics in Medicine and BiotechnologyA project of the European Commission,Quality of Life and Management of Living Resources Programme |
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| Date: | 09.12.2003, 10:00-16:00h |
| Location: | The Marriott Hotel Munich, Berliner Str. 93, 8O805 Munich Munich Germany |
| Details: | Morning: Surviving Regulatory Inspections and Understanding Quality Systems Successful GMP inspection is the goal of everyone who is involved with Manufacturing, QA, or Regulatory Affairs in the Life Sciences industries. But what are they and what are the inspectors looking for? Using the latest rulings and samples from recent inspections a comprehensive, step- by-step plan explains what needs to be done before, during, and after a GMP inspection. In addition, those specific items that an experienced inspector will look for will be discussed. Some "Do?s" and "Don?ts" to follow when inspections are underway and after the inspection is over. What will you learn: * What are the inspectors looking for during a GMP inspection? * What are the Quality systems that are inspected * How you can prepare for inspections * How to conduct an inspection * How to respond to observation Afternoon: Concept of Quality Systems, and Learning how to Design and Implement them Selected topics from the morning session will be expanded and discussed, attendees will learn how to design and implement a Quality System. In the Change Management session, attendees will learn how to design and implement a Change Control Program, and will actually design one. During the Discussion of Validation, the concept of validation and elements of a Validation Master Plan will be discussed. During the Process Validation session, in a very simple language, the concept of process validation will be explained. What will you learn: * How to design and implement a Quality System, hands on experience * Change Management * Validation, how to use it to your advantage, and what it really means * Process Validation, an easy to understand discussion of Process Validation concept |
| Organizer: | ibc Life Sciences , England |
| Contact: | Mrs Laura Beachus Address: The Booking Department, Informa Uk Limited, P.O. Box 406, KT 14 6NN West Byfleet, England Tel: +44 - 20 - 70 17 55 07 Fax: +44 - 20 - 70 17 47 49 Email: cust.serv@informa.com |
| Webpage: | http://www.ibc-lifesci.com/validation/ |
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