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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.

On-line Audio Seminar 190

Validation of Analytical Methods and Procedures

Conduct and Document for Efficiency and FDA, USP/EP and ISO 17025 Compliance


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Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. Method validation has been a requirement of FDA and international regulations and accreditation standards such as ISO 17025 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 are requirements of ISO 17025?
  • What parameters should be validated?
  • Which acceptance criteria MUST be defined and are acceptance limits?
  • Should standard and compendial 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
  • Examples of warning letters and how to avoid them
  • Requirements if ISO 17025
  • Developing an SOP for method validation
  • Development of a validation plan
  • Defining parameters and acceptance limits
  • Validation of standard methods
  • To revalidate or not after method changes
  • Transferring a method to routine
  • Using software for automated method validation
  • Documentation for the FDA, other agencies and for ISO 17025

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

  • SOPs
    - Validation of Analytical Methods
    - Validation of Chromatographic Methods
    - Transfer of Analytical Methods
    - Verification of Compendial Methods
    - Change versus Adjustment of Compendial 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)

Who should attend?

  • QA managers and personnel
  • Analysts and lab managers
  • Validation specialists
  • Training departments
  • Documentation department
  • Consultants

Date, time and duration

Thursday, February 28, 2008
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 our

How to order

Replaced by the more recent seminar

Validation of Analytical Methods and Procedures

Conduct and Document for Efficiency and FDA, USP/EP and ISO 17025 Compliance

Click here

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.