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

Title: Performance Verification Workshop  

Description: Defines the process for the execution and documentation of an Analytical Instrumentation Performance Verification. Includes the guidelines for ensuring system “readiness”, writing and execution of a protocol, evaluation of data, through final summary report. 

Length:  2 days

Audience:  Personnel involved in Instrumentation Maintenance, Laboratory, Quality Assurance personnel.

Learning Objectives: 

·         A clear understanding of the requirements for executing and documenting performance verification of analytical instrumentation

·         Clearly defines the differences between IQ/OQ/PQ and PV

·         Why is a PV critical

·         Downtime reduction through preventive maintenance

Content Outline:

Day 1 of 2

I.                     Introduction and Workshop Objectives

II.                   Definitions and Pre-requisites

III.                  Installation Qualification (IQ)/Operation Qualification (OQ)/Performance Qualification (PQ)

A.      Regulatory Expectations

B.      Site Requirements

C.      Key Elements

D.      Documentation

IV.                Pre-Validation Activities

A.      Benefits

B.      Recommendations   

V.                  Performance Verification

A.      Performance Verification versus Analytical Method Validation

B.      In House and Third Party

C.      Regulatory Expectations

D.      End User Responsibilities

E.      Key Required Elements

a.      Validated Test Methods

b.      Standard Test Methods

c.      Non-Validated Test Methods

F.      Data Handling and Data Review

G.     Required Documentation

Day 2 of 2

VI.                The Verification Summary Report

A.      Data Presentation

B.      Report Format

VII.               The Verification Package

A.      What does it look like

B.      Auditor Expectations

VIII.             Breakout Sessions

IX.                 Open Discussion