Audio Seminars

Home | Contact Us | Newsletter | Usersclub | Books | Audio Seminars

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
To share this seminar info with your colleagues, click here
...

On-line Audio Seminar 299

Calibration and Qualification of Stability Chambers

With 10 examples/templates for all qualification steps

Recorded, available with all reference material at any time

Order Button

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
To share this seminar info with your colleagues, click here
..

Key Questions related to qualification and calibration of stability chambers are:

  • What does FDA say about stability changer qualification?
  • What exactly are the expectations of inspectors?
  • What is the difference between calibration, qualification and testing?
  • Which parameters should be tested and what are the acceptance criteria?
  • Should we test parameters over the entire range, or is it enough to test at one point?
  • When and how much should we re-qualify, e.g., after repair or firmware upgrades? 
  • Who can or should test stability chambers, the vendor, user, 3rd party?
  • What to test after changes, e.g., when the equipment is moved, repaired or updated?
  • How to bring existing chambers into compliance?
  • Which documentation should be available for inspectors?

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..

During the interactive presentation you learn about:

  • FDA and equivalent international requirements
  • Examples for recent 483s and Warning Letters
  • Selection and qualification model: ASTM E2500, USP <1058>, V- or, 4-Q models
  • Calibration/qualification phases: design qualification, specifications, installation & operational qualification/verification testing, on-going performance qualification
  • Selecting parameters and acceptance limits for stability chambers initial testing
  • Selecting parameters and acceptance limits for stability chambers ongoing testing
  • Qualification for Photostability Testing Chambers
  • Requalification after equipment changes (move, repair, firmware upgrade, hardware upgrade)
  • Documentation requirements, e.g., humidity and temperature mapping
  • Common pitfalls
  • Sharing best practices

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

  • PowerPoint Presentation
  • Script
  • All questions and answers from before, during and after the seminar
  • Example SOPs:
    - Qualification and Calibration of Stability Chambers
    - Testing of Stability Chambers
    - Change Control for Equipment
    - Maintenance of Equipment
    - Development and Maintenance of Test Scripts
  •  Ten templates/examples - Stability chambers
    - Stability Chambers - Qualification Plan
    - Stability Chambers - Requirement Specifications
    - Stability Chambers - Risk Assessment
    - Stability Chambers - Vendor Assessment
    - Stability Chambers - Design Qualification
    - Stability Chambers - Installation Qualification
    - Stability Chambers - Operational Qualification
    - Stability Chambers - Performance Qualification
    - Stability Chambers - Test Sheet
    - Stability Chambers - Summary Report
  • Examples for FDA Warning Letters Related to Stability Chamber Qualification.
  • And more...

Who should attend?

  • (Bio)pharmaceutical and API industry
  • Contract laboratories
  • Stability laboratories
  • QC directors and substitutes
  • Laboratory managers and staff
  • Analysts
  • QA managers and personnel
  • 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.-
Order Now Button

Recorded seminar - CD

  • Get the CD in your mail
  • Order includes all reference material.

US$ 399.-
Order Now Button

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.-
Order Now Button

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,