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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 171

Verification of Compendial Methods

Understanding and Implementing the New USP Chapter <1226>

Recorded

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Compendial methods such as USP standards are validated by the organization that has 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 how to do and document this. The USP has developed a chapter about the verification of compendial methods. It is well known that FDA inspectors require USP standards or equivalent procedures to follow. Therefore pharmaceutical companies are advised to learn about the new chapter and about FDA's interpretation. When implemented right the standard also helps to reduce overall costs for implementing USP methods. Therefore there is lots of interest in learning about the new chapter.

Key Questions are:

  • What are FDA and international requirements for compendial methods?
  • What and how much should be tested?
  • Do all compendial routine methods require verification?
  • 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 I 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 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 the requirements for method verification and give practical recommendations. After the seminar, an extensive list of reference material like SOPs, worksheets, templates and examples will help immediate and cost effective implementation.

During the interactive presentation you learn about:

  • FDA and international requirements
  • The background on scope of USP <1226>
  • Status and timeline for implementation
  • Compendial methods not requiring verification
  • USP <1226> requirements
  • The USP high level verification process
  • Risk based approach for testing
  • Criteria and examples for degree and extent of the verification
  • Performance characteristics for verification
  • Elements for verification for different instruments
  • Verification for drug substances and dosage forms
  • Acceptance criteria for verification testing
  • Handling deviations
  • Investigating non-performance: root cause and corrective actions
  • Documenting the verification experiments and results
  • Typical costs of method verification

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

  • SOPs:
    - Verification of compendial methods
    - Validation of Chromatographic Methods
  • Checklist:
    - Verification of Compendial Methods
    - Validation of Analytical Methods and Procedures
  • Reference Article
    - Validation of standard methods
    - Validation of HPLC Methods
    - Validation of analytical methods: review and procedures
  • Warning letters and/or Inspectional observations related to analytical methods
  • 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
  • USP Presentation with examples: Verification of Compendial Procedures
  • FDA Guidance
    - Analytical procedures and methods validation
  • 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?

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

How to order

Replaced by the more recent seminar

Effective Verification of Compendial Methods

Understanding USP and FDA Requirements and get Tools for Implementation

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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.