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2016 - Web Conference by Compliance4all on Transfer of Analytical Methods and Procedures

Date2016-12-15

Deadline2016-12-14

VenueOnline, USA - United States USA - United States

KeywordsTools for Implementation; FDA and EU requirements; Developing a transfer plan

Websitehttp://www.compliance4all.com/control/w_...c_2016_SEO

Topics/Call fo Papers

Overview:
When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory. For a long time there was no official guidance on what exactly is expected to maintain 'the validated state'. In the meantime the USP has published an updated general chapter <1224>.
Areas Covered in the Session:
FDA and International expectations for method transfer
Examples of FDA warning letters and how to avoid them
The FDA Guidance on method transfer.
The USP chapter <1224>: history, status, future
The new EU GMP chapter 6 on method transfer
For Easy Implementation, Attendees Will Receive
SOP: Transfer of Analytical Methods
Checklist: Transfer of Analytical Methods and Procedures
Master Plan template and examples: - Transfer of Analytical Methods and procedures
Who Will Benefit:
Analysts
Lab Supervisors and Managers
QA managers and personnel
Analysts
Consultants
Teachers
Pack Offers
Speaker Profile:
Dr. Ludwig Huber Ph.D., is the director and editor of Labcompliance the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems, Informa Healthcare". He has given more than 300 presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. For more information, please visit Dr. Huber’s website www.ludwig-huber.com
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support-AT-compliance4All.com
http://www.compliance4all.com/
Event Link : http://www.compliance4all.com/control/w_product/~p...
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Last modified: 2016-11-03 14:38:39