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 299

Calibration and Qualification of Stability Chambers

With 10 examples/templates for all qualification steps

Recorded, available with all reference material at any time

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.-

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:

Study the printed slide material
Watch the slides on a computer
Watch the slides on a video screen in a seminar room
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,