Guidelines for New FDA Transfer of Analytical Methods

7 years ago Posted By : User Ref No: WURUR11592 0
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  • TypeWebinar
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  • Location Fresno, California, United States
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  • Date 18-05-2017
Guidelines for New FDA Transfer of Analytical Methods, Fresno, California, United States
Webinar Title
Guidelines for New FDA Transfer of Analytical Methods
Event Type
Webinar
Webinar Date
18-05-2017
Location
Fresno, California, United States
Organization Name / Organize By
Compliance4All
Organizing/Related Departments
Healthcare
Organization Type
Organization/Company
WebinarCategory
Both (Technical & Non Technical)
WebinarLevel
All (State/Province/Region, National & International)
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Education/Teaching/Training/Development

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Manufacturing

Medical/Healthcare/Hospital

Location
Fresno, California, United States

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'. Now the USP has published an updated general chapter <1224>. Also the FDA has released an official guidance on how to conduct and document method transfer. In addition the FDA has included requirements for method transfer in its new guidance from 2015 on validation of analytical methods. And last but not least Europe has released an updated GMP Chapter 6 with clear requirements for comparative testing and acceptance criteria. This seminar will give a good understanding of USP, FDA and EU requirements and provide recommendations and tools for effective implementation.

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

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: examples for type and extent of testing
  • Comparative testing according to the new FDA method validation guidance
  • The USP chapter <1224>: history, status, future
  • Gap analysis according to the new EU GMP chapter 6 on method transfer
  • Four approaches for analytical method transfer and testing
  • Responsibilities of the transferring and receiving laboratory
  • Developing a transfer plan and a pre-approval protocol
  • Criteria and approaches for risk based testing: what, when, how much?
  • Selecting parameters and acceptance criteria for comparative testing
  • Method transfer from standard HPLC to UHPLC
  • Most likely failures during method transfer
  • Handling deviations from documented acceptance criteria
  • Justification and criteria for transfer waiver (omission of formal transfer)
  • Method transfer protocol and summary report

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". 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

 

Others Details

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Registration Fees
Available
Registration Fees Details
One Dial-in One Attendee Price: $150.00 For more details and updates please visit webinar website
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  Online  Pin/Zip Code : 94539
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Event Manager

Netzealous LLC DBA - Compliance4All 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA. Phone: +1-800-447-9407 Email: [email protected]

   Fax No: 302-288-6884