GLP Regulations CONTENT Package

An integrated package that includes two must read articles, a powerpoint training presentation and trainer instructional notes. Package includes:

➢ 1. GLP Regulations: A Guide for Executing an Effective Regulatory Compliance Program; Reference Content (Article)

Click here to view complimentary excerpt

➢ 2. GLP Regulations: A Guide For Executing an Effective Regulatory Compliance Program (PowerPoint Training Presentation)

➢ 3. GLP Regulations: A Guide for Executing an Effective Regulatory Compliance Program (Trainer Instructional Notes)

➢ 4. Good Laboratory Practice Regulations vs. Good Manufacturing Practice Regulations: A Review of Their Intended Purposes and Requirements (Article)

1. GLP Regulations: A Guide for Executing an Effective Regulatory Compliance Program; Reference Content (Article)

Click here to view complimentary excerpt

This 15 page article serves as a must read for industry professionals who want to understand how GLP regulations serve as the foundation for executing an effective regulatory compliance program. This guide takes a lifecycle approach to the subject matter by reviewing the following subject matter, including:

➢Types of nonclinical studies

-Short-term studies

-Long-term exposure studies

-Other types of nonclinical studies

➢Good Laboratory Practice

-An overview

-Historical basis of GLP regulations

-PhRMA

-FIFRA

-GLP undergoes worldwide promulgation

-GLP regulations at a glance

-The role of QA under GLP

-Nonclinical study “phases” and QAU inspections

-Facility & process-based audits

-The GLP “QA” statement

-Test facility management

-The study director

-Operational personnel in the nonclinical study environment

-Nonclinical laboratory facilities

-Equipment for the conduct of nonclinical studies

-SOPs

-The nonclinical study protocol

-The nonclinical study report

-The master schedule

-Test article controls

➢Nonclinical laboratory studies and the FDA

-Initial IND submission to the FDA center

-Pharmacology and drug disposition

-Toxicology

-Statement of regulatory compliance

-FDA’s authority to inspect nonclinical laboratory testing facilities

-FDA inspectional approach

-The QA Unit as a focal point of FDA inspections

-Part 11 compliance and GLP

-Outsourcing nonclinical research

This article serves as reference content for the PowerPoint training presentation and Trainer Instructional Notes contained in this content package.

2. GLP Regulations: A Guide For Executing an Effective Regulatory Compliance Program (PowerPoint Training Presentation)

This 14 page PowerPoint Training Presentation includes subject matter content, including:

➢Nonclinical studies

➢Basis of Good Laboratory Practice (GLP)

➢Key GLP requirements

➢Nonclinical Studies and Quality Assurance Unit (QAU) Inspections

➢Test Facility Management

➢Study Director and Operational Personnel

➢Nonclinical Laboratory Facilities

➢Documentation Requirements

➢Nonclinical studies and the FDA

➢FDA Inspectional Approach

3. GLP Regulations: A Guide For Executing an Effective Regulatory Compliance Program (Trainer Instructional Notes)

These notes contain over 40 key discussion points related to the PowerPoint training presentation. Trainer instructional notes are designed to engage attendees and encourage their participation in the training.

4. Good Laboratory Practice Regulations vs. Good Manufacturing Practice Regulations: A Review of Their Intended Purposes and Requirements (Article)

GLP and GMP regulations are compared and contrasted in detail. Specific regulations (Part 211, Part 58, etc…) are reviewed. Subject matter includes:

➢Regulatory basis for GMP and GLP regulations

➢Operational environments

➢GLP in a GMP Analytical Laboratory

➢Differences between GMP and GLP Quality Control

➢GMP QC

➢Operational Needs for GLP and cGMP

A comparison chart of 24 GMP vs. GLP requirements are included in this article.

GLP Regulations CONTENT Package only $89.00