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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 259

FDA/ICH Compliant Development and Validation of Stability Indicating Methods 

Sample generation - method development - validation - documentation

Recorded, available at any time

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Stability indicating methods are quantitative test methods that can detect changes with time of drug substances and drug products. Information of type and amount of degradation products over time is important for safety of drugs. Therefore, FDA and other agencies but also good business practice require such methods to be well designed and validated.    

Key Questions related stability indicating methods are

  • What are stability indicating analytical methods
  • What are FDA/EU/ICH requirements
  • Where can I get practical advice from official committees?
  • Why do we need stability indicating methods?
  • When in product development should we develop stability indicating methods?
  • How to document the experiments and results for the FDA , EMEA and ICH
  • How to design development experiments?
  • How to select stress conditions?
  • How to avoid too much and too little degradation?
  • When should we validate the methods?
  • How to validate such methods?

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:

  • Regulatory expectations for stability indicating methods
  • FDA Warning Letters and how to avoid them
  • Business and compliance reasons for stability methods
  • Purpose and requirements for stability indicating methods
  • Planning for development
  • Design meaningful stress conditions for enforced degradation
  • Procedures and measurement of forced degradation
  • Special storage conditions
  • Strategies for efficient validation
  • Staged validation approach during development
  • Validation experiments
  • Practical hints for validation experiments
  • Documentation for FDA/EU GMP compliance

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

  • SOPs
    - Generating Stability Test Samples Through Forced Degradation
    - Validation of Stability Indicating Methods
    - Validation of Analytical Methods
  • Checklist:
    - Validation of Stability Indicating Methods
  • Forms/Template
    - Documentation Validation Summary
    - Planning template
  • Reference Paper
    - Forced Degradation Study To Develop & Validate Stability Indicating (link)
      Rplc Method For Quantification Of Nicardipine Hcl In Bulk And Tablet
      Formulation (link)
    - Guidance and Best Practices for Conducting Forced Degradation Studies
    - Validation of Analytical Methods: Review and Strategy
  • ICH Guidelines for stability testing and method validation
  • FDA Guidelines
  • Five FDA Warning Warning Letters related to stability methods and testing

Who should attend?

  • QA managers and personnel
  • Analysts and lab managers
  • Validation specialists
  • Training departments
  • Documentation department
  • Consultants
  • GLP/GMP/GCP auditors
  • Teachers

Date, time and duration

Order at any time, replay at any time, download the reference material at any time.

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.