Analytical Procedure Lifecycle Management / Revisions to ICH Q2 & the proposed Q14

Objectives

Over two days, the conference will present and illuminate current developments in this field. Experts from the expert groups and from the authorities will present the contents of the guidelines and draft guidelines and discuss the consequences for analytical quality control.

Background

On 14 November 2018, a Final Concept Paper “ICH Q14: Analytical Procedure Development and Revision of Q2(R1) Analytical Validation was published. It was proposed to develop a new quality guideline on Analytical Procedure Development and to revise the ICH Q2(R1) Guideline on Validation of Analytical Procedures: Text and Methodology. That means:

,,Q14 Analytical Procedure Development guideline
The new guideline is proposed for harmonising the scientific approaches of Analytical Procedure Development, and providing the principles relating to the description of Analytical Procedure Development process. Applying this guideline will improve regulatory communication between industry and regulators and facilitate more efficient, sound scientific and risk-based approval as well as post-approval change management of analytical procedures.

Q2(R1) Revision
The scope of the revision will include validation principles that cover analytical use of spectroscopic or spectrometry data (e.g., NIR, Raman, NMR or MS) some of which often require multivariate statistical analyses. The guideline will continue to provide a general framework for the principles of analytical procedure validation applicable to products mostly in the scope of Q6A and Q6B."

Target Audience

The ECA Academy wish to actively involve analytical chemists, QC analysts, quality assurance associates & managers, R&D scientists, statisticians & managers as well as manufacturing scientists and managers, regulatory affairs specialists and contract laboratories in this critical area for analytical science.
It is also useful for service providers, such as contract research organisations and contract manufacturers.

Programme - 12 November 2019

New ICH Q14 and ICH Q2 Revision – an industry view (Key Note Presentation at the Plenum)
Dr Joachim Ermer, Sanofi-Aventis Deutschland Head of QC Lifecycle Management Frankfurt Chemistry

Introduction to ECA AQCG
Dr Christopher Burgess, Chairman of the ECA AQCG Board

Overview of USP, ICH revisions & APLM Guideline; Prerequisites and approaches
Dr Christopher Burgess, Chairman of the ECA AQCG Board

Introduction to ATP & TMU
Phil Borman, GSK

Data integrity over the Analytical Procedure Lifecycle
Dr Bob McDowall, R.D. McDowall Limited

Stage 1: Procedure Design & Development
Margarita Sabater, LEO Pharma

Stage 1 in Practice
Phil Borman, GSK

Analytical Control Strategy Workshop
Dr Gerd Jilge, Boehringer Ingelheim
Margarita Sabater, LEO Pharma