Guidelines for New FDA Transfer of Analytical Methods - 2017

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Category FDA, Drug Administration, Analytical Methods, FDA Warning Letters, Guidelines, Masterplan, laboratory research, warning letter, form 483, warning letter to employee, Consultants, FDA Compliance Training

Deadline: May 17, 2017 | Date: May 18, 2017

Venue/Country: Online, U.S.A

Updated: 2017-03-21 16:25:48 (GMT+9)

Call For Papers - CFP

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,

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