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
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.
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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.-
|
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.
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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.