Day 1 – Agenda

A session at 2-day In-person Seminar on “Good Laboratory Practice Regulations - Introduction and Strategies for Implementation” at Mumbai

Thursday 21st March, 2013

9:00am to 6:00pm

Lecture 1: Introduction:
a.Introduction and History of the GLP Regulations
b.Definitions and General Application of the Regulations
c.FDA and International GLP regulations: 21 CFR Part 58, OECD

Lecture 2: Part I of the US GLP Regulations
a.Objectives and concepts of GLP's
b.Organization and Personnel Requirements
c.Special organizational requirements
d.Facility Requirements
e.Equipment Requirements

Lecture 3: Part 2 of the Regulations
a.Operation of the Testing Facility
b.Test and Control Articles

Lecture 4: Part 3 of the Regulations
a.Protocols for the Conduct of a Non-clinical Study
b.SOP requirements: type, formats and enforcement Contents
c.Records and Reports
d.Disqualification of Test Facilities

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Time 9:00am6:00pm HMT

Date Thu 21st March 2013

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