Labcompliance On-line Audio Seminar
Learn from the convenience of your desk or
with your colleagues in a seminar room
(to learn more about audio seminars,
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
March 31, 2010
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 calibrate 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 after instrument move?
- 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?
- 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 testing
- Requalification after equipment changes
(move, repair, firmware upgrade, hardware upgrade)
- Documentation requirements
- 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
- Nine templates/examples - Stability
chambers
- Stability Chambers - Qualification plan
- Stability Chambers - Requirement Specifications
- 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
- Seven Examples for FDA Warning Letters
Related to Stability Chamber Testing.
- 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
March 31, 2010
North America: ET 11 a.m. CT 10 a.m. PT 8 a.m., Europe: CET 5
p.m (Paris/Berlin)
Check: www.timeanddate.com/worldclock/ for you local time.
The seminar will last one hour
How to order
Pick one of the options in the table that fits your needs.
|
Standard offer
- Single person
- From the convenience of your desk
|
US$ 249.-
|
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'Site' offer
- Multiple persons - single site and phone line
- Meet in a seminar or conference room
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US$ 399.-
|
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Recorded seminar -
CD
- Get the CD in your mail
- Useful if you can/could not attend the on-line
seminar. Order includes all reference material.
|
US$ 399.-
|
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Recorded seminar -
Download Version
- Download from the Internet
- Listen and learn whenever you want, wherever you
want. Order includes all reference material.
|
US$ 399.-
|
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Special offer for
Labcompliance Usersclub Members
- Order includes all reference material.
- for Usersclub information and registration,
click here
|
from US$ 149.-
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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 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.