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 239

Qualification and Calibration of Stability Chambers

Learn how to select, conduct and document the right test parameters and conditions

 Recorded

Well performing stability chambers are most important to reliably predict shelf life specifications of drugs at different environmental conditions on the way from manufacturing to patients. FDA and international agencies expect  stability chambers to be qualified and calibrated to ensure proper performance when newly installed and over the length of a stability study. Even though this is well known since long time, laboratories are unsure on what exactly should be tested initially and on an on-going basis.

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
• Most frequently asked questions

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

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.-
Recorded seminar - CD Get the CD in your mail Order includes all reference material.	US$ 399.-
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.-

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 author of the Labcompliance Newsletter. He has been conducting over 100 web and audio or video based seminars since ten years. He is worldwide director for FDA compliance at Agilent Technologies.

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 visits FDA in Rockville, VA, and participates in panel discussions with FDA professionals. For more information, click here.