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70-page primer


Analytical method validation - A Regulatory Perspective

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 360

New Guidelines and Trends in Method Validation and Transfer 

Comply with new FDA, EMA, USP and Industry Guidelines

Recorded, available with all reference material at any time

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Method validation and transfer is receiving highest attention at FDA and industry. For example, several new important guidelines have been released from regulatory bodies and industry task forces for method development, validation and transfer. They include new FDA guides for method validation with elements of quality by design and for bioanalytical method validation, a new GMP chapter from Europe for method transfer, two new technical report from PDA on the lifecycle approach for analytical method validation of biotechnology products and several USP chapters with impact on revalidation and statistical evaluation. So the industry is confused about the many guidelines and is looking for expert advice. This presentation will discuss critical requirements and give recommendations on how to effectively implement them for (bio)pharmaceutical research, development and QC laboratories.

Key Questions related to new developments on method validation

  • Why is it that there are so many new guidelines?
  • What are the key points of each of the guideline
  • What is the purpose of new planned USP chapters 220, 1200, 1210 and 1220
  • Which of the new guidelines should be implemented
  • What are the key recommendation on how to implement the  guidelines
  • What are the common requirements?
  • Are there any requirements contradictory
  • How do the guides compare with ICH Q2?
  • Is ICH still required and is it still good enough
  • Do we need to implement quality by design
  • What are the benefits of the integrated lifecycle for design, development, validation
  • Which development studies must conducted under GMP conditions?
  • What are USP's plan to replace chapters 1224, 1225 and 1226?

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 an overview and give practical recommendations. After the seminar, an extensive list of reference material like SOPs, test scripts, templates and examples will help immediate and cost effective implementation. The seminar lasts one hour and will be conducted over the phone and supported by the Internet.

During the interactive presentation you learn about:

  • Limitations of the current regulations and guidelines for method validation
  • General trends in method validation, method transfer and verification
  • FDA and international enforcement and inspection practices:
    - warning letter examples
  • USP strategy for analytical methods: new chapters 1220 and 220
  • Going through the new guidelines and trends: scope and key points
    - FDA Guidance: Analytical procedures and methods for drugs and biologics
    - FDA guidance: Bioanalytical method validation
    - USP Chapter <1210>: Statistical tools for procedure validation
    - USP Chapter <1200>: Requirements for compendial validation
    - USP PF Stimuli paper: Lifecycle management of analytical procedures;
      Method development,  procedure performance qualification, and
      procedure for performance verification (proposal for new 1220)
    - EU GMP Chapter 6, Quality Control: Technical transfer of testing methods
    - PDA Technical Report 57 and 57-2: Analytical method development and
      qualification for biotechnology products
  • Comparison with ICH Q2 and USP 1225
  • Recommendations for what to implement and what to forget about
  • "Must do" for FDA/EU inspections

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

  • 70 page primer: Validation of Analytical Methods: Author Dr. Ludwig Huber
    Good overview of basic validation, verification and transfer  principles
  • SOPs
    - Validation of Analytical Methods
    - Verification of Compendial Methods
    - Transfer of analytical methods
  • Template/Checklist:
    - Validation of Analytical Methods according  to the FDA Guidance 2014
    - Transfer of Analytical Methods and Procedures
  • Example
    - Validation Report for Analytical Methods
  • USP Stimuli Article (link)
    - Lifecycle Management of Analytical Procedures: Method Development, Procedure Performance, Qualification, and Procedure Performance Verification
  •  New USP draft Chapters (links)
    -  <1200>: Requirements for compendial validation
    - <1210>: Statistical tools for procedure validation
    - USP PF Stimuli paper: Lifecycle management of analytical procedures;
      Method development,  procedure performance qualification, and
      procedure for performance verification (proposal for new <1220 >)
  • Five Warning letters and/or Inspectional observations related to method validation
  • FDA Guidance and Policy:
    - Bioanalytical Method Validation (draft 2013)
    - Analytical Procedures and Methods Validation (draft 2014)
  • FDA presentations on method validation
    - Analytical Methods Validation, A Regulatory Perspective
  • ICH Guidelines for the Industry Q2 (R1)
    - Text and Methodology on Validation of Analytical Procedures
  • Slides of the presentation as PPT files to train others
  • All questions and answers from before, during and after the seminar

Who should attend?

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

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.

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 explained FDA's next 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,