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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 339

Comparing GLP with GMP

Learn about similarities and differences and when to apply one or the other

Recorded, available with all reference material at any time

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Testimonials

We have received very positive feedback from attendees of previous seminars. For example, click here.

Introduction

Good Laboratory and Good Manufacturing practices are regulations that are applied during different lifecycle phases of drugs and drug substances. Both regulations have some common requirements but there are also significant differences. We at Labcompliance get many  questions about the differences between both of them and when and how exactly to apply one or the other? Key questions are:

Key Questions related to GLP vs. GLP are:

  • Who has to comply with GLP regulations, who with GMPs?
  • What are the key differences GLP and GMP?
  • When in product development starts GMP?
  • How do Good Clinical Practice regulations (GCPs) fit between GLP and GCP
  • Can we comply with GLP and GMP in the same environment?
  • Are DMPK studies regulated, and if so which regulation should we follow?
  • When do research labs have to comply with GMP or GLP?
  • We are operating under GMP, how to efficiently expand to GLP?
  • We are operating under GLP, how to expand to GMP?

How does the audio seminar help:

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 of either GLP or GMP.

During the interactive presentation you learn about:

  • Regulations along the drug lifecycle
  • Frequent misconceptions
  • Clarify objectives, the scope and applications of GLP vs. GMP
  • Common requirements of GLP and GMP
  • Key organizational differences and execution of tasks
  • Key documents
  • Going into  details of similarities/differences: procedures, personnel, equipment, methods, stability testing, reserve samples, raw data, archiving of records
  • Effectively moving from. GLP to GMP: step-by-Step
  • Expanding GMP to GLP: Step-by-Step
  • GLP and GMP in a single environment: what to care about
  • Circumstances  when research labs must comply with GMP or GLP
  • FDA inspections: timing, focus, enforcement in GLP vs. GMP

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

  • 120-page Primer: Good Laboratory Practices and Current Good Manufacturing Practices
  • Detailed worksheet: GLP vs. GMP Matrix
  • Master Plan Template and Examples: Building a GLP Laboratory
  • SOP: Going from GMP to GLP
  • SOP: Going from GLP to GMP
  • SOP: GLP Facilities and Environmental Control
  • SOP: Training for GMP Compliance
  • SOP: Training for GLP Compliance
  • SOP: Archiving and Retrieval of GMP Data and Other Documents
  • SOP: Archiving of GLP Data and Other Documents
  • SOP: Building a GMP System for International Environments
  • Checklist: Good Laboratory Practice Regulations
  • Checklist: Good Manufacturing Practice Regulations
  • FDA Warning Letters and inspectional observations related to GLP and GMP
  • FDA and International GMP and GLP regulations:
  • FDA Compliance Manual for Inspectors: Good Laboratory Practice (Nonclinical Studies)
  • And more...

Who should attend?

  • GMP operations going for GLP
  • GLP operations going for GMP
  • Laboratory managers and staff
  • Analysts
  • QA/QC managers and personnel
  • Regulatory affairs
  • Training departments
  • Documentation department
  • Consultants

Date, time and duration

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

Testimonials/References

 

 

The Feedback on the seminar has been received by e-mails. Labcompliance has permission to use the testimonials as references. Original e-mails are stored in the Labcompliance archive.

 

  • Erica Schnars, BioAgilytix Labs, QA, Corporate Compliance Manager , USA
    Feedback: The presentation was very informative. I enjoyed the table layout. The visual made it easy to follow and use later for reference. This was very insightful,  (Ref T-1171).

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

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's next steps for Part 11


Ludwig Huber (right) in a panel discussion with FDA inspectors and directors:
 Dr. Robert C. Horan, B Erik Henrikson,Joseph Famulare,  and Nicholas Buhay,