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Live Online Conference: Validation of Analytical Methods and Life Cycle Management of Analytical Procedures

23 November 2021, 09.00 - 17.30 h CET

Objectives

The Live Online Conference will present and highlight the current developments in the field of method validation and life cycle management. Experts from industry and laboratories will present the current status of the revision and the contents of the guidelines on the one hand, and their own experiences in the establishment and validation of methods and procedures on the other hand.

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."

Unfortunately, development is currently treading water a bit, but nevertheless many laboratories are already running corresponding methods and procedures and report on their experiences here. Also the USP has published a corresponding document with Chapter <1229>, which will also be presented during this conference.

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

New USP General Information Chapter <1220> Analytical Procedure Lifecycle
Dr Joachim Ermer, Ermer Quality Consulting

AQbD
tba

Transfer of Analytical Procedures, Bridging of Methods
Ulla Bondegaard, NovoNordisk

Established Conditions for Analytical Procedures & Application During the Analytical Life Cycle Management
Isabelle Moineau, AKTEHOM
Jean-Francois Dierick, GSK

How to Establish ATP for Small Molecules
Patrick Jackson, GSK

Update TMU
Dr Xaver Schratt, GB Pharma

Use of ATP to Guide Analytical Method Changes of Large Molecules
Dr Gerald Gellermann, Novartis

Analytical Procedure Lifecycle Management, Practical Implementation of Stage 3
Ulla Bondegaaard, Novo Nordisk

Optimization, Qualification and Validation of FcgR binding using SPR
Alexander Gill, Vela Labs

Deriving Fit-to-Purpose Validation Acceptance Criteria Based on Actual Testing Procedures by HPLC
Dr Pavel Parkhomyuk, Teva

Speakers

Ulla Bondegaard, NovoNordisk, Denmark
Responsible for maintaining cross-organisational (and cross-country) laboratory processes.

Jean-François Dierick, GSK Vaccines, Belgium
Global Subject Matter Expert Analytical Validation & Lifecycle.

Dr Joachim Ermer, Ermer Quality Consulting, Germany
CEO & Founder.

Dr Gerald Gellermann, Novatis, Switzerland
Analytical Lead at Novartis Biologics Development.

Alexander Gill, VelaLabs, Austria
Lab Technician.

Patrick Jackson, GSK, UK
Investigator in Chemistry, Manufacturing and Controls - Analytical.

Isabelle Moineau, AKTEHOM, France
Analytical Expert.

Dr Pavel Parkhomyuk, Teva Pharmaceutical Industries, Israel
Teva API Analytical R&D Manager.

Dr Xaver Schratt, GB Pharma, Germany
Head of Global Quality Management.