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How Much Can You Change An Official Method Before It Isn‘t The Official Method Anymore

Analytical Methods Validation, A Regulatory Perspective

Labcompliance Video Seminar 106

Video clips are recorded and imbedded in PowerPoint presentation slides. This allows highest flexibility. For example slides and clips can be skipped or replayed several times. The PowerPoint presentation with video clips come on a CD or as web download. Reference material such as 10+ best practice documents can be downloaded from a password protected website. The site and its updates can be accessed for two years.

Video Seminar 106

Validation of Analytical Methods and Procedures

Design, Conduct and Document for Efficiency and Compliance

With Dr. Ludwig Huber

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Analytical methods should validated to ensure reliability, consistency and and accuracy of analytical data. Method validation has been a requirement of FDA and international regulations since many years. Most often the theory is well understood but there are many questions when validation experiments are designed, conducted, and documented.

Key Questions related to Analytical Method Validation are:

  • What are FDA and international requirements?
  • What exactly are the expectations of inspectors?
  • What parameters should be validated?
  • Which acceptance criteria MUST be defined and are acceptance limits?
  • Should standard methods be validated?
  • Should we re-write compendial methods in SOP format?
  • How to validate bio-analytical methods?
  • What is the difference between accuracy and recovery?
  • What information should be included in regulatory submissions?
  • I want to transfer a method from development to routine lab, do we need to revalidate?
  • We want to transfer to an other site, do we need to revalidate?
  • How to document method validation for the FDA?
  • We have changed our method, should we revalidate?
  • We use software for automated method validation, should it be Part 11 compliant?

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 give practical recommendations. After the seminar, an extensive list of reference material like SOPs, templates and examples will help immediate and cost effective implementation.

During the interactive presentation you learn about:

  • FDA regulations and guidelines
  • Developing an SOP for method validation
  • Development of a validation plan
  • Defining parameters and acceptance limits
  • Validation of standard methods
  • Change control and revalidation
  • Transferring a method to routine
  • Using software for automated method validation
  • Documentation for the FDA and other agencies

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

  • SOPs
    - Validation of Chromatographic Methods
    - Transfer of Analytical Methods
  • Templates/Checklist:
    - Validation of Analytical Methods
    - Laboratory Audits
  • Reference Articles
    - Validation of Analytical Methods: Review and Strategy
    - Validation of HPLC methods
    - Evaluation and Validation of Standard Methods
    - Adjusting Conditions for a Routine Reversed-Phase HPLC Assay,
    Part II: Changing Separation Conditions (link)
  • Five Warning letters and/or Inspectional observations related to method validation
  • FDA Guidance and Policy:
    - Requesting Methods Validation for Abbreviated New Drug Applications
    - Bioanalytical Method Validation
    - Analytical Procedures and Methods Validation
  • FDA presentations on method validation
    - How Much Can You Change An Official Method Before It Isn‘t The Official Method Anymore?
    - Analytical Methods Validation, A Regulatory Perspective
  • ICH Guidelines for the Industry
    - Text on Validation of Analytical Procedures
    - Validation of Analytical Procedures: Methodology
  • Eurachem: The Fitness for Purpose of Analytical Methods, 70 pages (link)

Cost and Ordering

Video seminar - Web download

  • Download the video presentation from a password protected website (approx. 150 Mbytes)
  • Order includes all reference material.
  • Share the video and all reference material at your site

US$ 449.-
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Video seminar - CD

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

US$ 449.-
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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.