Zielsetzung
Hintergrund
Analytical Instrument Qualification (AIQ) and software validation are processes to ensure that analytical instruments or equipment are suitable for their intended use and produce reliable and accurate results. AIQ is critical for ensuring the quality and integrity of analytical data generated by the instrument, which is essential for making informed decisions in research, development, and quality control processes. It helps minimize the risk of errors, ensure compliance with regulatory requirements, and maintain confidence in the accuracy and reliability of analytical results. Requirements and guidance for the pharmaceutical industry are laid down, among others, by the
- EU GMP Guide
- EU GMP Annex 15: Qualification and Validation
- EU GMP Annex 11: Computerised Systems
- US GMP 21 CFR 211
- USP <1058> Analytical Instrument Qualification
- GAMP 5 Guide
Currently, a USP Expert Committee is reviewing and revising USP <1058>, and the proposal is to change the title of the general chapter to Analytical Instrument Qualification and System Validation (AIQSV).
The ECA Analytical Quality Control Group (AQCG) has developed a new Guide for an Integrated Lifecycle Approach to Analytical Instrument Qualification and System Validation. The ECA has decided to publish the Guide widely by allowing users to download the document free of charge. The PDF file is available in the AQCG members' area. Comments and recommendations related to version 1 of the document can be submitted until 30 June 2024, by using a form linked in the AQCG member area.
Zielgruppe
This conference will be of significant value to
- Laboratory managers, supervisors and analysts
- Quality control managers
- Heads of quality control
- Qualified Persons (QPs)
- Analytical scientists
- Senior laboratory staff
- Responsible authorities
Programm
Gesamtes Programm als PDF herunterladen
Data Quality & Data Integrity Lifecycle Overview
Dr Christopher Burgess, Chairman ECA AQCG
Overview of the ECA AQCG Guide to AIQ&SV
Dr Bob McDowall, R.D. McDowall Limited
Risk Assessment in AIQ&SV
Dr Christopher Burgess, Chairman ECA AQCG
Application of the AIQSV Approach to a Bioassay Analytical Instrument and Software
Margarita Sabater, Genmab
Risk-Based Qualification of HPLC Systems
Martina Gjorgjevska, Bionika Pharmaceuticals
Eurachem Guide for The Fitness for Purpose of Analytical Equipment
Dr Ernst Halder, Eurachem
Ongoing Monitoring in Analytical Instrument Performance Qualification
Dr Joachim Ermer, Ermer Quality Consulting
Overview of General Chapter <1220> Analytical Procedure Lifecycle
Dr Christopher Burgess, Chairman ECA AQCG
Using the Analytical Target Profile (ATP) for Efficient Procedure Lifecycle Management and Enhanced Analytical Platform Adoption
Dr Amanda Guiraldelli Mahr, formerly USP
Importance of Change Control and Deviation Management over the Lifecycle
Silviya Dimitrova, TEVA Pharmaceuticals Industries
Efficient Analytical Instrument Qualification - Bridging Laboratory Needs and GMP Compliance
Dr Nadine Mendl, ten23 health
Lifecycle Roles and Responsibilities
Patrick Jackson, GSK
Comparison of ICH Q2(R2), ICH Q14 & USP <1220> with the Draft General Chapter in the Chinese Pharmacopeia
Dr Gerd Jilge, Board Member ECA AQCG
Consideration of Uncertainty in Evaluation of Accuracy and Precision according to the New ICH Q2(R2)
Dr Joachim Ermer, Ermer Quality Consulting
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Teilnehmerstimmen
Seminarprogramm als PDF
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