Labcompliance On-line Audio Seminar

Learn from the convenience of your desk or with your colleagues in a seminar room
(to learn more about audio seminars, click here). To share this seminar info with your colleagues, click here...

On-line Audio Seminar 286

Implementing the New USP Chapter <1224> for Analytical Method Transfer

With SOPs, templates and examples for effective implementation

March 15, 2012

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. So far there has not been an official guidance on what exactly is expected to maintain 'the validated state'. Now the USP has approved a new general chapter <1224> for official use in May 2012 with USP 35. Also the FDA has released an official guidance for analytical method transfer. Now it is a good time to learn how to conduct and document transfer of analytical procedures according to USP and FDA expectations. However, transferring analytical methods raises a number of questions.

Key Questions are:

Method transfer is easy, why should we go through a formal process?
Are there any specific FDA requirements?
Are there examples for FDA warning letters?
What are recommendations from USP?
The standard suggests to base extent of testing on risk. How to do this?
Should the receiving laboratory do full revalidation?
What should be tested in the receiving laboratory?
What are most common mistakes during method transfer?
Anything special to care about for transfer to other sites?
When are system suitability tests sufficient?
How much can I change a transferred method without revalidation?
I want to transfer our standard method to hi-speed HPLC. What to do?
When can 'official' method transfer be omitted?
What to do if acceptance criteria are not met? Should we follow a formal OOS?
What are the responsibilities of the transferring and receiving laboratories
How should we 'formally' document method transfer?

How does the this audio seminar help:

Answers will be presented by Dr. Ludwig Huber in a new interactive audio seminar. During the seminar, the speaker will present strategies and give practical recommendations. After the seminar, an extensive list of reference material like SOPs, templates and a checklist will help immediate and cost effective implementation.

During the interactive presentation you learn about:

FDA and International expectations for method transfer
Examples of FDA warning letters and how to avoid them
The FDA Guidance on method transfer.
The new USP chapter <1224>: history, status, contents
Four approaches for analytical method transfer and testing
Selecting the best approach
Responsibilities of the transferring and receiving laboratory
Developing a transfer plan and a pre-approval protocol
Conducting comparative studies
Criteria and approaches for risk based testing: what, when, how much?
The importance and selection of acceptance criteria
Dealing with technology transfer: validation requirements, regulatory notification.
Method transfer from standard HPLC to UHPLC
Most likely failures during method transfer
Handling deviations from documented acceptance criteria
Criteria for transfer waiver (omission of formal transfer)
Method transfer protocol and summary report

And for easy and instant implementation:
download 10+ documents from special seminar website

Slides as PowerPoint Presentation, Script, Questions and Answers
Master Plan template and examples: - Transfer of Analytical Methods and procedures
SOPs
- Transfer of Analytical Methods
- Validation of Chromatographic Methods
- Change versus Adjustment of Analytical Methods
Case Study: Analytical Method Transfer Protocol
Checklist
- Transfer of Analytical Methods and Procedures
Reference Articles
- Validation of Analytical Methods: Review and Strategy
- Evaluation and Validation of Standard Methods
USP Stimuli Paper: Transfer of Analytical Procedures (link)
70 Page Primer: Validation of Analytical Methods
FDA Warning-letters and/or Inspectional observations related to method transfer
FDA Industry Guidance: Protocol for the Conduct of Method Transfer for Type C Medicated Feed Assay Methods
FDA Guidance and Policy:
- Analytical Procedures and Methods Validation
ICH Guidelines for the Industry
- Text and methodology for Validation of Analytical Procedures

Who should attend?

Everybody involved in method transfer
QA managers and personnel
Analysts and lab managers
Validation specialists
Training departments
Documentation department
Consultants

Date, time and duration

March 15, 2012
North America: ET 11 a.m. CT 10 a.m. PT 8 a.m., Europe: CET 5 p.m (Paris/Berlin)
Check: www.timeanddate.com/worldclock/ for you local time.
The seminar will last one hour

How to order

Pick one of the options in the table that fits your needs.

Standard offer Single person From the convenience of your desk	US$ 249.-
'Site' offer Multiple persons - single site and phone line Meet in a seminar or conference room	US$ 399.-
Recorded seminar - CD Get the CD in your mail Useful if you can/could not attend the on-line seminar. Order includes all reference material.	US$ 399.-
Recorded seminar - Download Version Download from the Internet Listen and learn whenever you want, wherever you want. Order includes all reference material.	US$ 399.-
Special offer for Labcompliance Usersclub Members Order includes all reference material. for Usersclub information and registration, click here	from US$ 149.-

Please forward to your colleagues

just click here

About audio seminars

Online audio seminars are presented over the phone. During the live presentation attendees can:

Study the printed slide material
Watch the slides on a computer
Watch the slides on a video screen in a seminar room
Ask questions through email and web form

About Dr. Ludwig Huber

Dr. Ludwig Huber is the author of the Labcompliance Newsletter. He has been conducting over 100 web and audio or video based seminars since ten years. He is worldwide director for FDA compliance at Agilent Technologies.

Dr. Ludwig Huber is a frequent presenter at IVT conferences and has been awarded as the 'Presenter of the Year' out of 170 speakers. This photo is from IVT's conference on Network Qualification with Ludwig Huber as plenary speaker.

Dr. Huber has published several books related to validation and compliance, for example: Validation of Computerized Analytical and Networked Systems. He was or still is a member of several committees, e.g., of the GAMP Special interest group (SIG) on Laboratory Computers, PDA Part 11 task force, IVT task force on network infrastructure qualification and the European Compliance Academy. He frequently visits FDA in Rockville, VA, and participates in panel discussions with FDA professionals. For more information, click here.

Dr. Ludwig Huber in Panel Discussions with FDA Officials

George Smith, FDA's national Part11 expert, at a panel discussion with Ludwig Huber during an IVT conference

Smith and Huber discussed and answered questions about computer system validation and e-records.

	Ludwig Huber (right) and John Murray, FDA's Computer Validation Expert, (left), speaking at the IVT Computer System Validation Conference. Mr. Murray explined FDA'snext steps for Part 11
	Ludwig Huber (right) in a panel discussion with FDA inspectors and directors: Dr. Robert C. Horan, B Erik Henrikson,Joseph Famulare, and Nicholas Buhay,