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1. How much can you change an official methods before it isn't the official method any more 

2. Analytical method validation - A Regulatory Perspective

Verification of Compendial Procedures

Learn from FDA Warning Letters what inspectors look for and what mistakes other companies make so you can avoid them

Labcompliance On-line Audio Seminar

This seminar has been recorded and is available on CD and for instant download. All reference material as listed below and more is available on a special seminar website. The website is regularly updated with most recent information. In case there are questions related to the topic, they can be submitted through a web form and will be answered by the speaker. For ordering info click here
To share this seminar info with your colleagues, click here

On-line Audio Seminar 367

Transfer of Analytical Methods According to New FDA, USP and EU-GMP Guidelines

With SOPs, templates and examples for easy implementation

Recorded, available with all reference material at any time

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Since USP released the first version of chapter <1224> for transfer of analytical procedures several other organization also developed guidelines on the same topic. First USP released a second version of its chapter, ISPE and WHO published guidelines as part of their technology transfer initiatives, the new EU GMP Chapter 6 gives some specific advice and also the most recent FDA Method Validation Guidance includes a related chapter. For example, one of FDA's recommendations is to include forced degradation test samples for comparative testing of stability indicating methods. So many guidelines with lots of different requirements raise a lot of questions for pharmaceutical laboratories.

Key Questions are:

  • Why became analytical method transfer so important?
  • What is the difference between the various guidelines?
  • Which ones are must requirements for the FDA/EMA
  • Which requirements are cited in FDA warning letters or 483's?
  • Are there any detailed recommendations for comparative testing, such as number of tests or acceptance criteria?
  • The USP new chapter standard suggests to base extent of testing on risk. How to do this?
  • What must be tested in the receiving laboratory?
  • Which of the guidelines describe tests required for method transfer
  • What are most common mistakes during method transfer?
  • Is there are step-by-step  procedure that satisfies FDA inspectors?
  • 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 ultra 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:

  • Current FDA and International expectations for method transfer
  • Examples of FDA warning letters and how to avoid them
  • Going through the details of various guidelines
    - The FDA industry guidance on method transfer
    - The method transfer chapter in the new FDA guide method validation guide
    - The method transfer chapter of the WHO technology transfer document
    - The method transfer chapter of the ISPE technology transfer document
    - The updated USP chapter <1224>
    - The new EU GMP chapter 6.
  • Common requirements of all guidelines
  • Good practice recommendations from individual guides
  • Most significant differences
  • Recommended approach for cost-effective and compliant transfer
  • Going through a step-by-step procedure for method transfer
  • Responsibilities of the transferring and receiving laboratory
  • Developing a transfer plan and a pre-approval protocol
  • Conducting comparative transfer studies: what, how much
  • Criteria and approaches for risk based testing: what, when, how much?
  • The importance and selection of acceptance criteria
  • 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
    - Validation of Chromatographic Methods
    - Transfer of Analytical Methods
    - Change versus Adjustment of Analytical Methods
  • Case Study: Analytical Method Transfer Protocol
  • Checklist
    Transfer of Analytical Methods and Procedures
  • Example
    - Preapproval protocol
  • USP Stimuli Paper: Transfer of HPLC Procedures to suitable Columns of Reduced Dimensions and Particle Sizes (Link)
  • 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 presentations on method validation
    Analytical Method Transfer (with three case studies)
    - Analytical Methods Validation, A Regulatory Perspective
  • FDA Guidance and Policy:
    - Analytical Procedures and Methods Validation
  • ICH Guidelines for the Industry
    - Text on Validation of Analytical Procedures
    - Validation of Analytical Procedures: Methodology

Example: Acceptance Criteria for Comparative Testing of Quantitative Impurities

Acceptance criteria for comparative testing are most important for method transfer. The seminar discusses several examples. 

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

Recorded seminar, available at any time with all reference material

How to order

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

Recorded seminar - Web Download

  • Multiple persons - single site
  • Learn at your desk, meet in a seminar or conference room or share the audio file and reference material at your site.
  • Order includes all reference material.

US$ 399.-
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Recorded seminar - CD

  • Get the CD in your mail
  • Order includes all reference material.

US$ 399.-
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Special offer for Labcompliance Usersclub Members
Recorded Seminar- CD or Web download.

  • Order includes all reference material.
  • for Usersclub information and registration, click here

US$ 299.-
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About audio seminars

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

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

About Dr. Ludwig Huber

Dr. Ludwig Huber is the editor and author of Labcompliance. He has been conducting over 300 web and audio or video based seminars since 15 years and and he has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars, workshops and presentations for the US FDA, SFDA, KFDA, HSA, ISPE, PDA, PIC/S and several national health agencies.

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 visited FDA in Rockville, VA, and participated in panel discussions with FDA professionals. For feedback from attendees of seminars and  for other information on Dr. Ludwig Huber, click here.

r. 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 explained FDA's next steps for Part 11