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
To share this seminar info with your colleagues,
click here..
On-line Audio Seminar 275
Good Laboratory Practice Regulations
Introduction and Strategies for
Implementation
Recorded, available with all reference material
at any time

Complying with GLP regulations can increase the cost of a laboratory up to 30%.
Companies or employees either don't know exactly what GLP really means, or what
procedures are required and how to implement GLP regulations. Lack of GLP
knowledge is also an inspection issue as training plans should include basic GLP
knowledge for everybody working in a GLP environment.
Key Questions are:
- What is GLP?
- Who has to comply with GLP regulations?
- What are the differences between FDA and international GLP
regulations?
- What are the differences between a GLP and non-GLP work?
- What are the incremental costs?
- What are the requirements?
- What are the responsibilities of analysts, supervisor, study
directors, QA and management?
- How should we archive GLP data: paper, microfiche,
electronic?
- How many SOPs are really needed?
- How to document GLP studies and protocols?
- How to deal with multi-site GLP studies?
- How to prepare the laboratory and staff for an FDA
inspection?
- What are the most frequently found deviations and how can we
avoid them?
How does the this audio seminar help:
A good understanding of GLP regulations and current FDA
interpretations together with a good strategy for implementation not
only can keep the costs under control but provides assurance that
the lab will pass FDA and other GLP inspections. Answers to the
questions above will be presented by Dr. Ludwig Huber in a new
interactive audio seminar. During the seminar, the speaker will give
an introduction on GLP, present strategies and give practical
recommendations. After the seminar, an extensive list of reference
material like SOPs, checklists, templates and examples will help
immediate and cost effective implementation
During the interactive presentation you learn about:
- FDA and International GLP regulations: 21 CFR Part 58, OECD
- Examples for FDA 483 inspectional observations and warning
letters
- Objectives and concepts of GLP's
- Special organizational requirements
- Responsibilities: Management, Study director, QA, analysts
- SOP requirements: type, formats and enforcement
- GLP studies: preparation, conduct, documentation
- Key requirements for equipment, facilities reference
material, people
- Data generation and evaluation: raw data, intermediate
results, final results
- Records keeping: format, length of time, archiving and
reprocessing
-
Strategies for Multi-site GLP Studies
- Preparing for FDA inspections
And for easy and instant implementation:
download 10+ documents from special seminar website
- Good Laboratory Practices and Current Good Manufacturing
Practices: 120 pages primer
- Gap Analysis/Checklist: Good Laboratory Practice Regulations
- Worksheet: Laboratory audits
- SOP: Recording of GLP Raw Data
- SOP: Archiving GLP Data and Other Documents
- SOP: Historical SOP File for GLP Regulations
- SOP: Handling and Reporting of GLP Study Deviations
- SOP: Generation and Maintenance of SOPs
- SOP: GLP Facilities and Environmental Control
- SOP: FDA inspections - Preparation, Conduct, Follow-up
- SOP: Handling Deviations from Standard Operating Procedures
- SOP: Training for GLP Compliance
- SOP: Retention and Archiving of Electronic Records
- Case Studies
- How to avoid GLP related 483's and
Warning Letters
- How to respond to GLP related 483's
and Warning Letters
- FDA Warning Letters and inspectional observations related to
GLP
- 21 CFR Part 58: Good Laboratory Practice for Non-clinical
Laboratory Studies
- FDA Compliance Manual for Inspectors: Good Laboratory
Practice (Nonclinical Studies)
- Inspection and Verification of Good Laboratory Practices:
Annex to EU Council Directive 88320EEC
- And more...
Who should attend?
- Lab Supervisors and Managers
- QA managers and personnel
- GLP auditors
- Analysts
- IT managers and personnel
- Consultants
- Teachers
Date and time
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
 |
Ludwig Huber (right) in a panel discussion with FDA
inspectors and directors:
Dr. Robert C. Horan, B Erik Henrikson, Joseph Famulare,
and Nicholas Buhay, |
 |
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 explained FDA'snext steps for Part 11
|