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Labcompliance On-line Audio Seminar

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On-line Audio Seminar 390

How to Efficiently  Build a GLP Laboratory

Step-by-step from design to cost-effective implementation

 April 5, 2018

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Being able to perform GLP studies expands a laboratory's business opportunities but there are also costs involved.  Performing GLP analysis internally as opposed to outsourcing them to contract laboratories can save time and money, especially for large sample number studies. However, because of regulatory requirements building a GLP laboratory needs to be thoroughly planned, designed and implemented. This holds for planning of organizational and management structure, for facilities and equipment, and for documented staff training. 

Key Questions related to building a GLP laboratory are:

  • Who has to comply with GLP regulations?
  • What are the differences between FDA and international GLP regulations?
  • What are the key differences between a GLP and non-GLP work?
  • What are the incremental costs?
  • What are the key benefits in-house GLP studies vs. outsourcing?
  • What are the key requirements related to laboratory facilities?
  • What are the management and organizational requirements?
  • Which type of documents should be developed?
  • Do we need any additional people with different qualifications?
  • How should we archive GLP data: paper, microfiche, electronic?
  • We already have ISO 17025, how to upgrade to GLP?
  • We already are GMP certified, how to upgrade to GLP?

How does the audio seminar help:

A good understanding of GLP regulations together with a good strategy for planning, design and 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 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
  • Similarity and difference to ISO 17025 and GMP
  • Documentation requirements: Policy, master plan, SOPs, records
  • Special organizational requirements: study director, QAU, archivist
  • Developing a master plan with step-by-step implementation plan
  • Developing SOPs. type, formats and enforcement
  • GLP studies: preparation, conduct, documentation
  • Hiring and management of the right personnel
  • Assigning tasks and responsibilities:: Management, study director, QA, analysts
  • Designing and/or optimizing the laboratory facilities for GLP Studies
  • Brining new and existing equipment and test methods into GLP compliance
  • Develop a strategy and a protected archive for electronic records
  • Records keeping: format, length of time, archiving and reprocessing
  • Upgrading from existing ISO 17025 accreditation and GMP compliance.

And for easy and instant implementation:
download 10+ documents from special seminar website

  • Master Plan Template and Examples: Building a GLP Laboratory
  • Good Laboratory Practices and Current Good Manufacturing Practices: 120 pages primer
  • Gap Analysis/Checklist: Good Laboratory Practice Regulations
  • Worksheet: Laboratory audits
  • SOP: Training for GLP Compliance
  • SOP: GLP Facilities and Environmental Control
  • SOP: Recording of GLP Raw Data
  • SOP: Archiving GLP Data and Other Documents
  • SOP: Historical SOP File for GLP Regulations
  • SOP: Retention and Archiving of Electronic Records
  • SOP: Handling and Reporting GLP Study Deviations
  • 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)
  • And more...

Who should attend?

  • Laboratory managers and staff
  • Analysts
  • QA managers and personnel
  • Regulatory affairs
  • Training departments
  • Documentation department
  • Consultants

Date and time

April 5, 2018
North America: ET 11 a.m.  CT 10 a.m. PT 8 a.m., Europe: CET
5 p.m. (Paris/Berlin)
Check: for you local time.
The seminar will last one hour

How to order

Pick one of the options in the table that fits your needs.

Standard offer

  • Single person
  • From the convenience of your desk

US$ 249.-
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'Site' offer

  • Multiple persons - single site and phone line
  • Meet in a seminar or conference room

US$ 399.-
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Recorded seminar - CD

  • Get the CD in your mail
  • Useful if you can/could not attend the on-line seminar. Order includes all reference material.

US$ 399.-
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Recorded seminar - Download Version

  • Download from the Internet
  • Listen and learn whenever you want, wherever you want. Order includes all reference material.

US$ 399.-
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Special offer for Labcompliance Usersclub Members

  • Order includes all reference material.
  • for Usersclub information and registration, click here

from US$ 149.-
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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.