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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
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.
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."
"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.
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.
New USP General Information Chapter <1220> Analytical Procedure Lifecycle
Dr Joachim Ermer, Ermer Quality Consulting
Analytical Development & Control for Complex Therapeutics – an Expedition via several Set-ups
Dr Markus Fido, MFI Bioconsulting
Analytical Procedure Lifecycle Management, Stage 2
Transfer of Analytical Procedures
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
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
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 Markus Fido, MFI Bioconsulting, Austria
CEO & Founder. Former CEO and founder of VelaLabs.
Dr Gerald Gellermann, Novatis, Switzerland
Analytical Lead at Novartis Biologics Development.
Alexander Gill, VelaLabs, Austria
Patrick Jackson, GSK, UK
Investigator in Chemistry, Manufacturing and Controls - Analytical.
Isabelle Moineau, AKTEHOM, France
Dr Pavel Parkhomyuk, Teva Pharmaceutical Industries, Israel
Teva API Analytical R&D Manager.
Dr Xaver Schratt, GB Pharma, Germany
Head of Global Quality Management.