Masters Certification Program on Annual GLP Refresher


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Duration: 8Hrs (4Hrs./Day)  + Breaks          

No of modules: 4 modules (2 Modules/Day)

Dates

·    8th April@11 AM EST, 

·    9th April @11 AM EST,

Mode of delivery: Online

CEU: 9

This interactive course will include discussions of current regulatory expectations including Data Integrity and is suitable for individuals new to the pharmaceutical industry and also serves as a refresher course for others.  It also has an emphasis on recent inspection trends and will therefore be of interest to the experienced pharmaceutical laboratory professional.  

This webinar will begin with a review of recent warning letters related to the GLPs and a discussion of the focus areas of the inspectors.   The discussion will be followed by a review of each of the key GLP systems with an emphasis on the Analytical Laboratory Systems and Data Integrity.  Common pitfalls in the implementation of the GLPs will be addressed during the discussion related to each area.  

Target participants

All personnel involved in GLP studies

Lab personnel

Study Directors

QA personnel

QA Management

Documentation personnel

R&D Lab personnel

R&D Lab Supervisors

Learning Objectives

  • Module 1: Recent warning letters. 

·         Review of recent warning letters  related to the GLPs

·         Discussion of the focus areas of the Inspectors.

  • Module 2: GLP requirements for Personnel

·         The GLP Org chart

·         Roles and responsibilities of the Management, Study Director, QAU and Archivist

·         Personnel training

  • Module 3: GLP requirements for the Facility

·         Requirements for the animal housing areas

·         Requirements for storing the test article and reference

·         Requirements for the lab space

·         Requirement for Archival space

  • Module 4: GLP requirements for the Equipment

·         Equipment design

·         Maintenance, Calibration and Qualification of Equipment

  • Module 5: GLP Test Article and Reference

·         Testing and Certificate of Analysis

·         Labeling the test article and Reference

·         Storage of the Test Article and Reference

  • Module 6: Documentation of the GLP Study

·         The Study Protocol

·         Documentation during the study – Good Documentation Practices

·         The Study report

  • Module 7: GLP Study Records

·         Documents that need to be archived

·         Specimens that need to be archived


Eastern Standard Time

10.00 am to 12.00 Noon: Review of recent warning letters related to GLPs.  

11 AM: 10 min break with Q&A session

12.00 Noon to 1 pm EST: Lunch

1.00pm EST to 3.00pm EST:  GLP requirements for Personnel Equipment and Facility. 

2 PM EST:  10 min break with Q&A session

3.00 pm EST to 3.15 pm EST: Break

3.15 pm EST to 5.15 pm EST: Steps in a GLP study.  GLP requirement for the Test Article, GLP Study Protocols, Documentation, Study report and Archival of Study-related documents.   

4.15 PM EST:  10 min break with Q&A session

5.15 PM EST: Final Q&A Session

Webinar Events
Live -Coming soon!

Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment


Recorded video

Recorded video session






Get in touch

(315) 632-0735,
(315) 750-4379