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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
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On-line Audio Seminar 275

Good Laboratory Practice Regulations

Introduction and Strategies for Implementation

Recorded, available with all reference material at any time

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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.-
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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.-
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About audio seminars

 

Online audio seminars are presented over the phone. During the live presentation attendees can:

  1. Study the printed slide material
  2. Watch the slides on a computer
  3. Watch the slides on a video screen in a seminar room
  4. 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