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70-page primer


Analytical method validation - A Regulatory Perspective

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
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On-line Audio Seminar 365

Understanding the Final FDA Guidance for Validation of Analytical Methods

With 10+ best practice guides for easy implementation

Recorded, available with all reference material at any time

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Recently the FDA has released a new comprehensive guidance for validation of analytical methods. The guidance applies the modern integrated lifecycle approach with related new requirements for using quality-by-design components, risk assessment, design space and continuous improvement. The guidance will significantly change the way how FDA regulated methods will be developed, validated and used. Because of the novelty of some of the concepts the industry has difficulties to understand and implement the guidance.

Key Questions related to the new FDA method validation guidance are:

  • What are the differences to the existing draft guidance from 2000?
  • What are the differences to the first version of this guidance from 2014?
  • What is the scope of the new guidance, when does it apply?
  • How does the guide compare with ICH Q2?
  • How to apply the integrated lifecycle?
  • How to apply risk assessment?
  • What are the recommended validation parameters, tests and acceptance criteria?
  • Which QbD components does the guide recommend?
  • What to test for alternative analytical methods?
  • Should validation experiments be conducted under GMP conditions?
  • Which development studies should be submitted to the FDA?
  • What exactly are the expectations for documentation?
  • How does the FDA verify submitted methods?
  • How to get re-approval when we change approved methods?

How does the 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 an overview and give practical recommendations. After the seminar, an extensive list of reference material like SOPs, test scripts, templates and examples will help immediate and cost effective implementation. The seminar lasts one hour and will be conducted over the phone and supported by the Internet.

During the interactive presentation you learn about:

  • Key differences to the existing dtaft guidance and to the first revisiob
  • Scope and content of the guidance
  • Going through validation parameters, tests, and acceptance criteria
  • Comparison with ICH Q2
  • Lifecycle management of analytical procedures
  • Periodic review and revalidation
  • Analytical method comparability studies for alternative analytical procedures
  • Analytical method transfer studies
  • Development experiments that should be conducted under GMP conditions
  • Application of QbD components: design space, multivariate experiments, risk assessment
  • Documentation requirements
  • Verification of submitted methods at the FDA
  • Reporting post-marketing changes to an approved method

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

  • 70 page primer: Validation of Analytical Methods
    written by Dr. Ludwig Huber
  • SOPs
    - Validation of Analytical Methods
    - Verification of Compendial Methods
    - Change versus Adjustment of Compendial Methods
  • Template/Checklist:
    - Validation of Analytical Methods according  to the new FDA Guidance
  • Example
    - Validation Report for Analytical Methods
  • USP Stimuli Article (link)
    - Lifecycle Management of Analytical Procedures: Method Development, Procedure Performance, Qualification, and Procedure Performance Verification
  • Three Reference Articles
  • Five Warning letters and/or Inspectional observations related to method validation
  • FDA Guidance and Policy:
    - Bioanalytical Method Validation
    - Analytical Procedures and Methods Validation for Drugs and Biologics
  • FDA presentations on method validation
    - Analytical Methods Validation, A Regulatory Perspective
  • ICH Guidelines for the Industry Q2 (R1)
    - Text and Methodology on Validation of Analytical Procedures
  • Slides of the presentation as PPT files to train others
  • Script of the presentation
  • All questions and answers from before, during and after the seminar

Attend the seminar to learn about all details on what's new compared to the first revision and to the 15 year old existing guide

Who should attend?

  • Laboratory managers and staff
  • Analysts
  • QA managers and personnel
  • Regulatory affairs
  • Training departments
  • Documentation department
  • Consultants
  • Validation specialists

Date and time

August 20, 2015
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

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.


. 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

Ludwig Huber (right) in a panel discussion with FDA inspectors and directors:
 Dr. Robert C. Horan, B Erik Henrikson,Joseph Famulare,  and Nicholas Buhay,