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 organization

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, microfiche, electronic?
• How many SOPs are really needed?
• How to document GLP studies and protocols?
• 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 about:

• 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 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
• 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 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: Facilities and Environmental Control
• SOP: FDA inspections - Preparation, Conduct, Follow-up
• SOP: Handling Deviations from Standard Operating Procedures
• SOP: Training for GxP, 21 CFR Part 11 and Computer Validation
• SOP: Retention and Archiving of Electronic Records
• SOP for EMEA GLP Inspections
• 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...

How to use the training?

• As overview and start up-training for new employees
• 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
• Analysts
• IT managers and personnel
• Consultants
• Teachers

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	US$ 449.-
Video seminar - CD Get the CD in your mail Order includes all reference material.	US$ 449.-

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.