Analytical Method Validation for Pharmaceutical Quality Control

Date	Sep 13, 2018
Time	11:00 AM EDT
Cost	$80520.00
Online

The use of appropriately-validated test methods is an essential requirement of Good Manufacturing Practice. This course provides an overview of current regulatory guidance, as well as practical advice on planning and executing method validation and verification studies. Group exercises and case studies are used to reinforce learning.

Areas Covered:

• Understand regulatory expectations for method validation/verification
• Be familiar with validation terminology and experimental approaches to method validation
• Know how to write effective test methods and validation protocols
• Be able to set meaningful acceptance criteria
• Understand the extent of method validation required at each stage of development
• Have strategies for dealing with validation failures
• Understand how to set system suitability limits

Who Should Attend:

• Quality Assurance Departments

• Quality Control Departments

• Validation Specialists

• Analysts and Other Laboratory Staff

• Lab Supervisors and Managers

• Regulatory Affairs Departments

• GLP/GCP/GMP Auditors

• Research and Development Departments