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All documents shown here are included in the seminar for instant download

 

The package includes several forms that are useful for conducting and documenting stability studies

The package includes a list of fequently asked questions and answers related to stability testing

The package includes 10 FDA Warning Letters related to stability testing

 

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 233

Stability Testing in Pharmaceutical and API Industry

Learn how to design, conduct and document studies for FDA and ICH

Recorded

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Stability testing and monitoring is a critical step in drug research, development and manufacturing. It impacts the safety of drugs and how pharmaceuticals are produced, packaged, labeled, stored and sold. Therefore stability testing is strictly regulated and heavily enforced by FDA and other agencies. Guidelines require to monitor degradation products over storage time to assure that the integrity of product  remains unchanged throughout its shelf life. However, stability testing is a complex process and despite of the fact that guidelines have been available since quite some time from ICH and other organization, industry still has problems to meet the expectations of inspectors.

Key Questions related to stability testing are:

  • Which guidelines should we follow; ICH, WHO, FDA?
  • Where can we get information on which countries follows which climate zone?
  • What are the exact temperatures?
  • What are the test times?
  • What are the conditions for accelerated testing?
  • How to predict shelf life from accelerated testing
  • What is matrixing?
  • What to test for bracketing?
  • What is the allowed time allowed between due date and analysis date for stability?

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 and checklist will help immediate and cost effective implementation.

During the interactive presentation you learn about:

  • FDA, ICH and WHO requirements and guidelines
  • Inspection and Enforcement practices: Examples for FDA warning letters
  • Stability testing along the drug life: preclinical and clinical phases, manufacturing
  • Developing a a stability plan and SOPs
  • Testing conditions for various climate zones and regions
  • Design of accelerated testing and estimating shelf life
  • Specific OOS and OOT requirements
  • Taking advantage of bracketing and and matrixing
  • Stress testing and enforced degradations:
  • Calibration and qualification of stability chambers
  • Validation of stability indicating analytical procedures
  • Potential pitfalls
  • Documentation requirements

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

  • PowerPoint Presentation
  • Script
  • Master plan: Stability Studies of Pharmaceutical Drug Substances and Finished Products
  • SOP: Validation of Stability Indicating Methods
  • SOP: Stability Testing
  • Case Study: Stability Matrixing and Bracketing
  • Checklist: Shelf Life Testing
  • ICH guidelines related to stability testing
  • Form: Design of stability testing
  • Form: Stability reporting
  • 10 FDA Warning Letters related to stability testing

Who should attend?

  • (Bio)pharmaceutical development and manufacturing
  • API development and manufacturing
  • Stability labs
  • Raw Materials Testing Group
  • Formulation
  • Laboratory managers and staff
  • QC directors and 'Qualified Persons'
  • QA managers and personnel
  • Training departments
  • Documentation department
  • Consultants

Date, time and duration

Order at any time, replay 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.