MHPM H P C O N S U L T A N T S, L L C

Title: Analytical Method Validation Training Workshop

Description: Defines the process for performing and documenting an Analytical Method Validation. Includes assessment of method readiness, writing and execution of a protocol, evaluation of data and the Method Validation Summary Report.  This workshop also provides insight as to when re-qualification and/or re-validation are required.

Length:  3 days

Audience:  Scientists, managers, and personnel involved in methods development, method validation, and quality assurance/control personnel.

Learning Objectives: 

·         A clear understanding of the required validation parameters and their definitions

·         Systematic approach to documenting the process used to perform analytical method validations

·         When to re-qualify or re-validate

·         Application of validation and qualification characteristics to all analytical instrumentation.

Content Outline:

Day 1 of 3

I.                     Introduction and Workshop Objectives

II.                   Overview

A.      Key Regulatory Documents

B.      Regulatory Expectations

III.                  Definitions and Pre-requisites

IV.                Qualification versus Validation

A.      New Method

B.      Compendial Methods

C.      Method Modification

a.      Re-Qualification versus Re-Validation

D.      Technical Transfer

E.      USP and other requirements

V.                  Analytical Method Validation

A.      Validation Characteristics

B.      Stress Testing

C.      Solution Stability

D.      Stability Indicating Method

E.      Handling of Out-of-Specification Test Result and Protocol Exceptions

                  Day 2 of 3

I.                     The Analytical Method Validation Protocol

A.   Validation Characteristics

B.   Acceptance Criteria

C.   Template/Format

Day 3 of 3

I.          The Analytical Method Validation Summary Report

A.     Data Evaluation

B.     Data Presentation

C.     Report Format

II.                   The Analytical Method Validation Package

A.      Regulatory Expectations

B.      Content

III.                  Open Discussion

Breakout Sessions – Incorporated throughout the 3 day session

I.                     Evaluating a Test Method

a.      Qualification versus validation

II.                   Method Modification

a.      Re-Qualification or Re-Validation

III.                  The Validation Protocol

a.      Identifying Validation Characteristics

b.      Determination of Acceptance Criteria

IV.                The Analytical Method Validation Summary Report

a.      Key Elements

b.      Organization

c.      Presentation of Data

d.      Validation Summary

e.      Out-of-Specification/Protocol Exceptions

f.        Review/Approval