Labcompliance Video Seminar 104
Video clips are recorded and imbedded in
PowerPoint presentation slides. This allows highest flexibility. For
example slides and clips can be skipped or replayed several times.
The PowerPoint presentation with video clips come on a CD or as web
download. Reference material such as 10+ best practice documents can
be downloaded from a password protected website. The site and its
updates can be accessed for two years..
Video Seminar 104
Good Laboratory Practices
Objectives, requirements and impact on your
With Dr. Ludwig Huber
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, 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.
Questions related to Good Laboratory Practices 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,
- How many SOPs are really needed?
- How to document GLP studies and
- 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 video 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 this video 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. and at any
time, attendees can ask questions though a web form.
During the interactive presentation you learn
- FDA and International GLP regulations: 21
CFR Part 58
- Objectives and concepts of GLP's
- Special organizational requirements
- Responsibilities: Management, Study
director, QA, analysts
- SOP requirements: type, formats and
- GLP studies: preparation, conduct,
- 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
- Preparing for FDA inspections
- Real life examples
And for easy and instant implementation:
download 10+ documents from dedicated seminar website
- Good Laboratory Practices and Current
Good Manufacturing Practices: 120 pages primer
- Gap Analysis/Checklist: Good Laboratory
- Worksheet: Laboratory audits
- SOP: Recording of GLP Raw Data
- SOP: Archiving GLP Data and Other
- SOP: Historical SOP File for GLP
- SOP: Handling and Reporting of GLP Study
- SOP: Generation and Maintenance of SOPs
- SOP: Facilities and Environmental Control
- SOP: FDA inspections - Preparation,
- SOP: Handling Deviations from Standard
- SOP: Training for GLP Compliance
- SOP: Retention and Archiving of
- 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
- FDA Compliance Manual for Inspectors:
Good Laboratory Practice (Nonclinical Studies)
- And more...
How to use the training?
- As overview and start up-training for new
- As anual GLP refresher by everybody
affected by GLP
- With the best practices tool for
effective implementation of GLP
Who should attend?
- All employees affected by GLP
- Lab Supervisors and Managers
- QA managers and personnel
- GLP auditors
- IT managers and personnel
Cost and Ordering
Video seminar - Web download
- Download the video presentation from a password protected website
(approx. 150 Mbytes)
- Order includes all reference material.
- Share the video and all reference material at your site
Video seminar - CD
- Get the CD in your mail
- Order includes all reference material.
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
||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,