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