Masters Certification Program on Annual GLP Refresher

N.S
Oct 9, 2020 - 11:00 AM EST
Starting at

$999


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

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

Dates

·    9th Oct@11 AM EST, 

·    12th Oct @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
Attend Live Webinar
Oct 9, 2020 - 11:00 AM EST

Duration: 7 Hours

Single Attendee


Group of 3 to 5 + 1 Thumb Drive/Recorded Version


Group of 6 to 10 + 1 Thumb Drive/Recorded Version


Training CD-DVD

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


Recorded video

Recorded video session



Speaker: N.S, Senior Consultant, Biologics Consulting Group

Speaker is currently the Group Leader for Analytics CMC Group and Senior Consultant with the Biologics Consulting Group specializing in Analytical, Stability, CMC, and GLP/GMP Quality Systems. She has assisted pharma and biotech organizations in the evaluation of analytical methods and method validation for a wide range of products from the pre-clinical phase to commercial phases. Some specific technical areas include small-molecule pharmaceuticals, well-characterized proteins including biosimilars and vaccines.  Her consulting areas include GMP systems design and implementation focusing on laboratory and stability systems, data integrity, and equipment.  She currently serves as an Editorial Advisor for Bioprocess International.  


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