is being presented by Dr. Ludwig Huber, Director, of LabCompliance and airs on Wednesday, June 15th, 2011. For more details or to register, please visit our site at www.fxconferences.com
It is important to maintain the validated state when transferring validated methods between laboratories and sites, so that the receiving laboratory can produce the same reliable results. However, to date there has been no official guidance on what exactly is expected to maintain 'the validated state'. That is changing. The U.S. Pharmacopeia (USP) recently published a proposal for a general chapter <1224>, which will become official with USP 35. Also, the FDA has released an official guidance on how to conduct and document method transfer.
This audio conference presentation looks at FDA and international expectations for method transfer, and discusses how to properly conduct and document a transfer. It explores the various approaches and laboratory responsibilities, and looks at how to develop a transfer plan and pre-approval protocol. The speaker also provides attendees with an understanding of USP and FDA requirements, and provides recommendations and tools for effective implementation.
Showing posts with label Dr. Ludwig Huber. Show all posts
Showing posts with label Dr. Ludwig Huber. Show all posts
Thursday, May 26, 2011
Monday, March 21, 2011
Understanding and Implementing the New EU Annex 11
is being presented by Dr. Ludwig Huber, Director, with LabCompliance and airs on Tuesday, April 26th, 2011. For more details, or to register please visit our site at www.fxconferences.com
After more than 15 years the EU has released a new final version of Annex 11. Together with the updated EU Chapter 4 on documentation, it forms the EU equivalent to FDA's Part 11. Compared to the older version, it has more details and some very specific requirements. It addresses the regulatory needs of modern IT equipment, and when implemented correctly, it also has business benefits through reduced failure rates. The document is a good framework for validation and use of computer systems and handling electronic records in different regulated environments.
This audio conference presentation provides attendees with an overview and a good understanding of the Annex 11 requirements, and also provides recommendations and tools for cost-effective implementation.
After more than 15 years the EU has released a new final version of Annex 11. Together with the updated EU Chapter 4 on documentation, it forms the EU equivalent to FDA's Part 11. Compared to the older version, it has more details and some very specific requirements. It addresses the regulatory needs of modern IT equipment, and when implemented correctly, it also has business benefits through reduced failure rates. The document is a good framework for validation and use of computer systems and handling electronic records in different regulated environments.
This audio conference presentation provides attendees with an overview and a good understanding of the Annex 11 requirements, and also provides recommendations and tools for cost-effective implementation.
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