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

12 and 13 November 2019

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

Congress Keynote 12.11.2019: New ICH Q14 and ICH Q2 Revision – an industry view (Key Note Presentation at the Plenum)

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
Bob McDowall, R.D. McDowall Limited

Stage 1: Procedure Design & Development
Margarita Sabater, Dako Denmark, an Agilent Technologies Company

Stage 1 in Practice
Phil Borman, GSK

Analytical Control Strategy Workshop
Dr Gerd Jilge, Boehringer Ingelheim
Margarita Sabater, Dako Denmark, an Agilent Technologies Company

Programme - 13 November 2019

Congress Keynote 13.11.2019: Laboratory Services - from Outsourcing to a strategic partnership (Key Note Presentation at the Plenum)

Laboratory Services - from Outsourcing to a strategic partnership (Key Note Presentation at the Plenum)
Dr Jürgen Balles, Dr Thomas Meindl and Ingo Grimm, Labor LS

Stage 2: Procedure Performance Qualification: Problems and issues?
Dr Gerd Jilge, Boehringer Ingelheim

Approaches to the transfer of Analytical Procedures
Ulla Bondegaard, Novo Nordisk

Stage 3: Procedure Performance Verification
Silviya Dimitrova, Teva

Experiences in the ongoing verification of Analytical Procedures
Ulla Bondegaard, Novo Nordisk

"What happens with Legacy Products?" Workshop
Silviya Dimitrova, Teva
Dr Christopher Burgess, Burgess Analytical Consultancy

Moderation

Dr Christopher Burgess, Burgess Analytical Consultancy Limited

Speakers

Ulla Bondegaard, Novo Nordisk, Denmark
Currently responsible for maintaining cross-organisational (and cross-country) laboratory processes.

Phil Borman, GSK, UK
Director Product Development & Supply. Member of various analytical teams (e.g. EFPIA, USP and
BP) supporting the development of ICHQ2(R2)/Q14.

Dr Christopher Burgess, Burgess Analytical Consultancy, UK
Chairman of the ECA Analytical Quality Control Working Group. Qualified Person” in the EU. Member of the USP Expert Panel on Validation and Verification entrusted to revise General Chapters.

Silviya Dimitrova, Teva Bulgaria
Member of the ECA QC Group Board and QP. Overall responsibility for quality oversight of European TEVA suppliers as well as QC and QP Release.

Dr Gerd Jilge, Boehringer Ingelheim, Germany
Quality Control. Member of the EDQM expert group 11 and Board Member of the ECA AQC Group.

Bob McDowall, R.D. McDowall Limited, USA
Director.

Margarita Sabater, Dako Denmark, an Agilent Technologies Company
Manager Compliance Support at Dako, Board Member of the ECA QC Group