Guidelines for New FDA Transfer of Analytical Methods - 2017
FDA has released an official guidance on how to conduct and document method transfer.
Wed, May 17, 2017 10:00 AM (PDT)
Online,
Fremont,
California
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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'.
Areas Covered in the Session:
Four approaches for analytical method transfer and testing
Responsibilities of the transferring and receiving laboratory
Developing a transfer plan and a pre-approval protocol
Who Will Benefit:
Analysts
Lab Supervisors and Managers
QA Managers and Personnel
Consultants
Teachers
Speaker Profile:
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".
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com
Full Details & Registration Link: http://www.compliance4all.com/control/w_product/~product_id=501277LIVE?channel=ticketprinting_May_2017_SEO
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'.
Areas Covered in the Session:
Four approaches for analytical method transfer and testing
Responsibilities of the transferring and receiving laboratory
Developing a transfer plan and a pre-approval protocol
Who Will Benefit:
Analysts
Lab Supervisors and Managers
QA Managers and Personnel
Consultants
Teachers
Speaker Profile:
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".
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com
Full Details & Registration Link: http://www.compliance4all.com/control/w_product/~product_id=501277LIVE?channel=ticketprinting_May_2017_SEO
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