GLP Regulations – Introduction and Strategies for Implementation

$299.00

Description:

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. Attend the seminar to get a good understanding on GLP regulations and get best practice guides and strategies for easy implementation.

For easy implementation, attendees will receive:

Good Laboratory Practices and Current Good Manufacturing Practices: 120 pages e-book
Gap Analysis/Checklist: Good Laboratory Practice Regulations
SOP: Archiving GLP Data and Other Documents

Areas to be Covered:

FDA and International GLP regulations: 21 CFR Part 58, OECD
Examples for FDA 483 inspectional observations and warning letters
Objectives, scope 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

Who will Benefit:

A must attend webinar for professionals in Pharmaceutical and medical device industry, Manufacturers of drug substances (APIs) and Contract laboratories, Contract manufacturing organizations, Clinical research organizations. The teams that will benefit the most are:

Lab Supervisors and Managers
QA Managers and Personnel
GLP Auditors
GLP Study Directors
Analysts
Consultants
Teachers
Everybody getting involved in GLP studies

Dr. Ludwig Huber

Ludwig Huber, Ph.D., is the director of Labcompliance and editor of (www.labcompliance.com), the global online resource for validation and compliance. He is the author of the books “Validation and Qualification in Analytical Laboratories” and “Validation of Computerized Analytical and Networked Systems”. He has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11, 21CFR Part 111 and Validation around the world. This included seminars, workshops and presentations for the US FDA, China SFDA, Korea MFDS, Singapore HSA, ISPE, Japan PDA, PIC/S and several other national health care agencies. For more information, please visit Dr.Huber’s website (www.ludwig-huber.com).

$299.00

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance