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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 346

Review of Analytical Methods as Alternative to regular Revalidation

Understand how to remain in compliance at much lower costs and at higher effectiveness

Recorded, available with all reference material at any time

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Recent regulatory guidance documents and industry task forces promote regular periodic review as more effective and compliant alternatives to time based revalidation. For example, the most recent FDA Guidance document on analytical method validation does not say a single word about 'regular' revalidation. And the PDA report on Analytical Method Validation recommends reviewing periodically historically data to ensure continuous validated state and controlled method performance. While the benefits of regular methods reviews are are well understood the process is not widely used because of limited experience and missing guidelines for implementation.

Key Questions related to Periodic  Reviews of Analytical methods are:

  • We revalidate all our methods every year, and we revalidate after changes, why should we review?
  • What are exact FDA and international requirements?
  • What are the benefits of periodic review?
  • Does periodic method validation review substitute regular revalidation?
  • What is the recommended frequency reviews: 6, 12, 24 months, or less?
  • What events trigger periodic review, method change control, system suitability failures, OOS situations, others?
  • Where to get inputs for periodic reviews?
  • Who should be responsible for the review?
  • Which information and data are required for the review?
  • How long does a review meeting take?
  • What are possible action items following a review?

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, checklists and examples will help immediate and cost effective implementation.

During the interactive presentation you learn about:

  • FDA and international requirements to ensure on-going method performance
  • Inspection and enforcement practices
  • Purpose and objectives of periodic reviews of analytical methods
  • The role and benefits of periodic review vs. revalidation
  • Developing an SOP for periodic review
  • Criteria and justification for frequency of reviews vs. revalidation
  • Data sources and documents that should be reviewed
  • The review process from planning to documentation
  • Responsibilities, tasks and owners for the review
  • Follow-up corrective and preventive actions
  • Periodic reviews to improve continuous method performance
  • Documentation for the FDA and other agencies

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

  • PowerPoint Presentation (helpful to train others)
  • SOPs
    - Review of Analytical Methods and Procedures
    - Change versus Adjustment of Analytical Methods
  • Checklist: Review of Analytical Methods and Procedures
  • Forms
    - Documenting Deviations of Method Reviews
    - Documenting Corrective Actions of Method Reviews
  • Lessons from 11 FDA Warning Letters
  • Frequently asked questions and answers
  • Others

Who should attend?

Industry

  • Pharmaceutical development and manufacturing
  • Biopharmaceutical development and manufacturing
  • Manufacturers of drug substances (APIs)
  • Contract laboratories

Functions

  • QA managers and personnel
  • QC and Lab managers
  • Validation specialists
  • Regulatory affairs
  • Human resources (HR) managers and staff
  • Training departments
  • Documentation department
  • Consultants

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,