Titel: Pre-Conference Workshop: Understanding Quality Systems and Surviving Regulatory Inspections
Beginn:
9.12.2003
Veranstaltungsort:
Berliner Str. 93
8O805 Munich
Referenten: see their page for more information
Weitere Informationen:
http://www.ibc-lifesci.com/validation/
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 "Dos" and "Donts" 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
Kontakt:
Mrs Laura Beachus
The Booking Department
Informa Uk Limited
P.O. Box 406
KT 14 6NN West Byfleet
England
phone: +44 - 20 - 70 17 55 07
fax: +44 - 20 - 70 17 47 49
cust.serv@informa.com
Veranstalter: ibc Life Sciences