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
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On-line Audio Seminar 260
Learning from Recent
Warning Letters Related to Good Laboratory Practices
For Preparation of FDA and International
GLP Inspections
Recorded, available with the reference material
at any time

The number of FDA warning letters issued by the FDA has
been increasing over the last couple of years,
especially in the area of Good Laboratory Practice
regulations. Warning letters and 483's are ideal tools to prepare an
organization for FDA inspections. They are useful to learn what inspectors are
asking and what mistakes other companies make so you can avoid them. While FDA
regulations and even guidance documents don't change for long time, FDA
inspection practices do. And since they have to be approved by FDA management
they do not express the opinion of single inspectors but FDA's current thinking.
They are much more up-to-date than regulations and FDA guidelines. And even
though most FDA warning letters are publicly available on the FDA website, it is
difficult to find the ones relevant to GLP regulation and to assess the impact
on your GLP study.
Key Questions related to GLP and
Warning Letters are:
- What is FDA's most current thinking
related to GLP?
- What are the current
inspection trends?
- What are most frequent recent citations
related to FDA's GLP regulation?
- How to avoid FDA 483 Inspectional
observations?
- How to best respond to 483's to avoid
warning letters?
- Are there proven tools that help to
implement GLP strategies?
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 examples and
recommendations on how to avoid FDA warning letters and 483's. After
the seminar, an extensive list of reference material like case
studies, SOPs, checklists and templates will help immediate
and cost effective implementation of a GLP
program that is in line with current and future FDA's expectations.
The seminar lasts one hour and will be conducted over the phone and
supported by the Internet.
During the interactive presentation you learn
about:
- FDA inspections: Preparation, conducts,
follow up
- The meaning of GLP
warning letters and 483 inspectional observations
- Examples of recent GLP
related 483’s and Warning Letters
- Most obvious reasons for deviations
- Proven practices to avoid FDA 483's
- Responding to 483's to avoid warning
letters: going through case studies
- Writing corrective and preventive action
plans as follow up to 483's
- Strategies and tools for compliant GLP
implementation
- The future of GLP inspections
And for easy and instant implementation:
download 10+ documents from special seminar website
- Six example SOPs:
- FDA Inspections: Preparation, Conduct, Follow-up
- Retention and Archiving of Electronic Records
- Recording of GLP Raw Data
- Historical SOP File for GLP Regulations
- Archiving GLP Data and Other Documents
- Handling and Reporting of GLP Study Deviations
- Checklists:
- Good Laboratory Practice Regulations
- Laboratory Audits
- Case Studies
- How to avoid GLP related 483's and
Warning Letters
- How to respond to GLP related 483's
and Warning Letters
- 10 warning letters and Inspectional
observations with typical deviations related to
Good Laboratory Practice regulations
- FDA Compliance Manual for Inspectors: Good Laboratory
Practice (Nonclinical Studies)
- SOP for EMA GLP Inspection
- Good Laboratory Practices and Current Good Manufacturing
Practices: 120 pages primer (2.3 Mbytes)
Who should attend?
The seminar is a must for everybody involved in GLP studies and
related FDA and international inspections
- GLP Lab Personnel, Supervisors and Managers
- QA managers and personnel
- GLP auditors
- Archivists
- IT managers and personnel
- Consultants
- Teachers
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.-

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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.-

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Please forward to your colleagues, just
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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 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.
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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 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.