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Recorded Webinar

GLP Regulations – A Simplified Overview for Academia, Pharmaceutical, and Biotech Industry

timelapse 60 mins with 10-15 mins of Q and A

Note:

This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times

Speaker/Presenter

Short Abstract

The main purpose of the role of the Good Laboratory Practice (GLP) Quality Assurance (QA) professional is to assure management of the compliance with the GLP regulations within their departments. GLP is the quality system applied to non-clinical safety and environmental studies during the development of new products such as medicines, industrial chemicals and pesticides. GLP gives assurance that study data submitted to government assessors is accurate, valid and of sound integrity. Monitoring for GLP compliance by the QA Professional involves conducting audits of the facilities, of ongoing work in the facilities and of various documents.

The presentation will cover the following areas:

  • FDA and International GLP regulations: 21 CFR Part 58
  • Objectives and concepts of GLP
  • Organization and Personnel: Management, study director, QA, and analysts.
  • Facilities: Key requirements for animal care, laboratory operation, specimen and data storage, equipment, and test and reference articles
  • Protocols for conduct of laboratory study
  • Records and Reporting: format and archiving
  • FDA inspections


Apply for this webinar

Who should attend

This overview webcast is intended for individuals whose functions have direct or indirect involvement with FDA inspections. These functions include among others:

  • Regulatory Affairs
  • Quality Assurance Staff
  • Scientists
  • Quality Assurance Staff
  • Documentation Management
  • All staffs who are assigned GLP responsibilities

Content Disclaimer

Contents in our website are from external websites. Links to and content from external website are provided for the convenience of users. Biopractice.com takes no responsibility for the content of such links and websites.

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