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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
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On-line Audio Seminar 296

Verification of Compendial Methods according to the Revised USP Chapter <1226>

Understand the new risk based approach and get real world case studies for testing

Recorded, available with all reference material at any time

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Compendial methods such as USP and EP standards are validated by the organizations that have developed and published the method. The FDA requires users of such methods to demonstrate the user's competence to successfully run the method. For example, 21 CFR 211.194 (a) states: The suitability of all testing methods used shall be verified under actual conditions of use. However, the FDA does not give any further guidance on what, when and how. And the first revision of USP <1226> did not have specific recommendations. But FDA inspectors go out and write 483's and warning letters related to <1226>. Now USP did come out with a new revision using the risk based approach for the type and extent of testing. Because there are no further guidelines there are still many questions.

Key Questions are:

  • What are FDA and international requirements for compendial methods?
  • What and how much should be tested?
  • How to aply the risk based approach?
  • Is system suitability testing enough?
  • Do all compendial routine methods require verification?
  • When could just system suitability testing be enough?
  • Should we verify all performance characteristics?
  • How much can we deviate from the compendial method without the need for a full revalidation?
  • What to do if the compendial procedure can not be verified?
  • How frequently should compendial methods be re-verified?
  • What if our equipment was not included in the USP method validation experiments

How does 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 the requirements for method verification and give practical recommendations. After the seminar, an extensive list of reference material like SOPs, real world case studies for testing, worksheets, templates and examples will help immediate and cost effective implementation.

During the interactive presentation you learn about:

  • FDA and international requirements for verification of compendial methods
  • Inspection and enforcement practices: examples for recent FDA warning letters
  • The background and scope of USP <1226>
  • What's new in the second revision?
  • Compendial methods not requiring verification
  • The USP verification process
  • USP <1226> requirements for verification and testing
  • Risk based approach for type and extent of testing
  • Performance characteristics for verification testing: proven industry examples
  • Acceptance criteria for testing
  • How much can compendial methods be changed
  • Change vs. adjustment of compendial methods
  • Investigating non-performance: root cause and corrective actions
  • Documenting the verification experiments and results

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

  • SOPs:
    - Verification of Compendial Methods
    - Change vs. Adjustments of Compendial Methods
    - Validation of Chromatographic Methods
  • Checklist:
    - Verification of Compendial Methods
    - Validation of Analytical Methods and Procedures
  • Case Studies; Verification of Compendial methods and procedures
  • AOAC Guide: How to Meet ISO 17025 Requirements for Method Verification (link)
  • Reference Article
    - Validation of Standard Methods
    - Validation of HPLC Methods
    - Validation of analytical methods: review and procedures
  • Recent FDA Warning Letters and/or Inspectional observations related to verification of compendial methods
  • USP Presentation with test examples: Verification of Compendial Procedures
  • Proposed revision of the USP <1226> (link)
  • FDA Guidance
    - Analytical procedures and methods validation
  • ICH Guideline for the Industry
    - Validation of Analytical Procedures
    : Definitions and Methodology

Who should attend?

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

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.

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,