Conference Programme

Introduction to the ECA Foundation and Academy

Dr Christopher Burgess, Chairman of the ECA AQCG Board

Overview of the Workshop

Dr Christopher Burgess, Chairman of the ECA AQCG Board

• Limitations of the current ICH Q2(R1) & USP General Chapters
• Principles of Analytical Procedure Lifecycle Management (APLM)
• Importance of adopting an APLM approach in the context of data integrity governance
• „„Workshop intent and process

Overview of the new APLM Guideline

Dr Christopher Burgess, Chairman of the ECA AQCG Board

• ECA Guidelines; intent and applications
• „„APLM process overview
• „„Regulatory background
• „„Content of new guideline

Quality by Design; Application to Analytical Procedures

Phil Nethercote (USP V&V Expert Panel)

• History and background to the initiative to apply QbD principles to analytical procedures
• Advantages
• Key elements of this approach

Development of an ATP

Kimber Barnett (USP V&V Expert Panel)

The importance of Target Measurement Uncertainty in an ATP

Jane Weitzel (USP V&V Expert Panel)

• Target measurement uncertainty (TMU) is the maximum value for the uncertainty associated with a reportable value in order for it to be fit for purpose. It is one of the key components in the Lifecycle approach to analytical procedures
• TMU helps define the analytical target profile (ATP)
• TMU is required to determine the probability stated in a decision rule
• TMU is a key performance criterion for analytical procedure performance throughout its life, from development through qualification and continued verification of performance

Workshop 1 on ATPs

Moderators: Kimber Barnett & Jane Weitzel (USP V&V Expert Panel)

Defining an Analytical Control Strategy

Margarita Sabater (ECA AQCG Board)

• Definition of an ACS
• Identification of the analytical procedure variables that impact the ATP based on Risk Management
• Key elements of this Approach

Workshop 2 on AQbD to deliver an ATP (Stage 1)

Moderators: Phil Nethercote (USP V&V Expert Panel) & Margarita Sabater (ECA AQCG Board)

Panel Q&A and Review of Day 1

ICH Q2A Revision Process; Aims and Objectives

Dr Gerd Jilge, (ECA AQCG Board)

• „A general approach for the validation of all relevant analytical procures
• „„Discussion on the revision of the terminology of validation parameters
• „„Definition of a “variability” of an analytical procedure
• „„Implementation into the process of the “Analytical Target Profile” and the Life cycle process

Stage 2: Procedure Performance Qualification (PPQ)

Dr Joachim Ermer, (USP V&V Expert Panel)

• Alignments, differences and advantages to traditional validation
• General and procedure-specific performance attributes
• Experimental confirmation in stage 2 or reference to stage 1?
• Precision of the reportable value and replication strategy

Workshop 3: Designing a Procedure Performance Qualification (PPQ) protocol to confirm the ATP

Moderators: Dr Gerd Jilge, (ECA AQCG Board) & Dr Joachim Ermer, (USP V&V Expert Panel)

On going Performance Verification; Stage 3 (Principles & Approaches)

Dr Christopher Burgess, Chairman of the ECA AQCG Board

• Analytical Procedures as processes
• „„Process stability and capability
• „„Requirements for routine process monitoring of analytical procedures
• „„Quality Metrics

On going Performance Verification; Stage 3 (Analytical trending to ensure a state of control)

Silviya Dimitrova (ECA AQCG Board)

• „„What to trend and what not to trend
• „„Trending as part of the analytical control strategy and confirmation of the ATP
• „„Are we trying to control means or individuals?
• „„Overview of trending tools for discrete and variable data

Workshop 4: Designing a Procedure Verification Strategy to confirm a State of Control

Dr Christopher Burgess and Silviya Dimitrova (ECA AQCG Board)

• Defining critical analytical procedure steps
• „„Specification limits versus analytical trend limits
• „„Selecting the right statistical tools for the job
• „„Evaluating and interpreting trend data

Final Panel Discussion - “The Way Forward”