Introduction to the AQCG’s new ECA Guide for an Integrated Lifecycle Approach to Analytical Instrument Qualification and System Validation

Monday, 29 April 2024 10.00 - 16.00 h

Course No. 21679

header-image

Speakers

Dr. Christopher Burgess

Dr. Christopher Burgess

Burgess Analytical Consultancy

Dr. Bob McDowall

Dr. Bob McDowall

R.D. McDowall Ltd.

Dr Amanda Guiraldelli-Mahr

Dr Amanda Guiraldelli-Mahr

Scientific Affairs Manager at United States Pharmacopoeia

All times mentioned are CEST.

Objectives

The objectives of this Live Online Training are:
  • Understand the rationale for the lifecycle approach for new ECA AIQSV Guide
  • Learn the risk-based risk assessment approach to determine ‘fitness for use’
  • Overview of these principles to specific examples for analytical instruments and Systems
  • Provide an insight into the ECA AQCG collaboration with the USP

Background

Although qualification of analytical instruments has been a regulatory requirement in the GMP regulations since the 1970s, it was only the publication of United Stated Pharmacopoeia (USP) General Chapter <1058> on Analytical Instrument Qualification in 2008 that provided a formal requirement. This is still the only pharmacopoeial general chapter on the subject. In 2017, <1058> was updated and currently there are Stimuli to the Revision Process articles about moving from the 4Qs Model to a three phase lifecycle model to be congruent with USP <1220> on Analytical Procedure Lifecycle.

The ECA Analytical Quality Control Group (AQCG) Guide for an Integrated Lifecycle Approach to Analytical Instrument Qualification and System Validation (AIQSV) was written to be a practical guide for risk-based instrument qualification and system validation. It adopts a three-phase lifecycle and not the 4Qs model similar to proposals for update of USP <1058>. The Guide has six appendices outlining how to qualify and validate common instruments and systems used in GMP regulated laboratories.

All participants receive a free copy of the new Guide and the other guides developed by the AQCG for download.

Target Group

This Live Online Training is aimed at the following:
  • Managers and staff from Quality Control and Analytical Development Laboratories of pharmaceutical companies, Contract Research Organisations and Contract Manufacturing Organisations involved in Qualifying analytical instruments and Systems
  • CSV staff involved in validating laboratory computerised Systems
  • Quality Assurance staff involved in reviewing laboratory qualification and validation documents
  • Auditors (internal and external) responsible for auditing qualification and validation of analytical Instruments and systems

Technical Requirements

We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-trainingtechnical- information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.

Programme

Introduction to the AQCG’s new ECA Guide for an Integrated Lifecycle Approach to Analytical Instrument Qualification and System Validation

Seminar Programme as PDF

Introduction to the Live Online Training and the AQCG
Dr Markus Funk (CONCEPT HEIDELBERG and Administration Manager of the ECA AQCG)
  • Overview of the structure and activities of the ECA FOUNDATION
  • Introduce the ECA AQCG Board
  • AQCG Aims & Objectives
  • ECA AQCG Published Guidelines
Introduction to the new AQCG ECA AIQSV Guide
Dr Chris Burgess, Burgess Analytical Consultancy Ltd, UK
  • Rationale for the Guide and the development process
  • Acknowledgements
  • What’s in and what’s out of the AIQSV guide
  • Collaborative 2-day meeting with USP on practical implementation at PharmaLab on 26/27 November 2024 in Düsseldorf/Neuss
An overview of the AIQSV Lifecycle
Dr Chris Burgess, Burgess Analytical Consultancy Ltd, UK
  • Why the 4Qs model is inadequate for most analytical instruments and Systems
  • IQ, OQ and PQ dropped by FDA in 2002 and GAMP in 2008
  • Lifecycle phases and threads
  • Phase 1: Specify and Select
  • Phase 2: Qualification / Validation of Instruments and Systems
  • Phase 3: Continued Performance Verification
  • Who does what; Roles and Responsibilities
Evolution of Analytical Procedure Validation: The Analytical Procedure Lifecycle
Dr Amanda Guiraldelli-Mahr, United States Pharmacopoeia
  • USP’s journey in the creation of compendial approaches incorporating QbD principles
  • Introduction to the Analytical Procedure Lifecycle Framework described in USP <1220>
  • USP Analytical Instrument Qualification (AIQ) Joint Subcommittees and collaborative efforts
  • Stimuli Articles on AIQ, update on the revision of USP <1058> and collaborative 2-day Workshop to allow broader stakeholder input & debate
  • Planned two-day AQCG/USP session at PharmaLab 2024
AIQSV Risk Assessment; an Integrated Approach
Dr Bob McDowall, R.D.McDowall Limited, UK
  • Overview of the AIQSV Guide risk assessment
  • Understanding why a different intended use defines a different USP <1058> Group and sub type for the same make and model of instrument/System
  • Analytical computerised systems are not created equal: validation approaches vary from a single integrated validation document to a networked CDS
Overview of Qualification of Chromatographs and Validation of Chromatography Data Systems
Dr Bob McDowall, R.D.McDowall Limited, UK
  • Laboratory specification of liquid chromatographs versus supplier specifications
  • Supplier’s qualification protocols and qualification data
  • Risk based validation of a chromatography data System
  • Specifying testable or verifiable user requirements
  • How to leverage the supplier software development and testing
  • Practical user acceptance testing
Wash Up Session & Close of Meeting
Dr Chris Burgess, Burgess Analytical Consultancy Ltd, UK
  • Review and feedback on Guide
  • Soliciting topics for the two-day AIQSV Guide meeting at PharmaLab 2024

This training/webinar cannot be booked. Send us your inquiry by using the following contact form.

To find alternative dates for this training/webinar or similar events please see the complete list of all events.

For many training courses and webinars, there are also recordings you can order and watch any time. Just take a look at the complete list of all recordings.

* also payable by credit card
American Express Visa Mastercard

icon
Further dates on-site
Further dates on-site
Not available
icon
Further dates online
Further dates online
Not available
icon
Recording
Not available

Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

Woman with headset

Go back

Testimonials about our courses and conferences

"Great material and speakers" and "Great speakers a lot of experience and sharing"

Felipe Gonzalez, Mucos Emulsionsgesellschaft mbH
Live Online Training - Granulation & Tableting, September 2024

"The lectures were very informative, interesting and entertaining."

Albert Godoy Hernández, Company synaffix
Live Online Training - GMP Auditor Practice, October 2024

"Really useful training which I will use in my daily work."

Regina Mommaerts, Galapagos NV
Live Online Training - GMP Auditor Practice, October 2024

"Wonderful format of the sessions: Good range of participations and experience in the team. Would love to attend another one soon."

Roopasi Mathi, Wacker Biotech B.V.
Live Online Training - GMP Auditor Practice, October 2024

"Very good balance between general and detailed information"

Dr Ralf Albrecht, Tillotts Pharma AG
Live Online Training - Granulation & Tableting
September 2024

"Nice presentations: easy understanding, quite visual"

Susana Manrique, Boehringer Ingelheim España, S.A,
Live Online Training - Granulation & Tableting, September 2024

“Fantastic course – I really enjoyed the interactive structure & greatly appreciate social activity.”

Anthony Cummins, Sebela Pharmaceuticals, Ireland
GMP Auditor Practice, September 2023

 

“Very well organized, information on point without being overwhelming.”

Eleni Kallinikou, Pharmathen
Live Online Trainng - Pharmaceutical Contracts - Febuary 2024

 

“Good overview of different types of agreements, good to see both the GMP and the legal angle”

Ann Michiels, Johnson&Johnson
Live Online Trainng - Pharmaceutical Contracts, Febuary 2024

 

 

“Well prepared presentations and good presenters. I also like the way of asking questions.”

Alexandra Weidler, Hookipa Biotech GmbH, Austria
Live Online Training – QP Education Course Module A, November 2023