Speakers

Dr. Christopher Burgess

Burgess Analytical Consultancy

Roland Miksche

MiRo Consulting

All times mentioned are CEST.

Objectives

The objective of this Live Online Training is to provide the participants with an overview of the regulatory requirements on the qualification of analytical equipment and to give practical advice on successful approaches to calibration, qualification, validation, and routine monitoring of instrumentation and systems. Key requirements of the important USP General Chapter <1058> will be presented and discussed.

The course will cover the following instruments and systems amongst others:

UV/VIS
NIR
RAMAN
GC

Target Group

This Live Online Training will be of practical value to scientists and engineers in analytical laboratories and contract laboratories in an FDA-/GMP-regulated environment who are responsible for the calibration and qualification of their laboratory equipment.

Technical Requirements

For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programme

Live Online Training: Analytical Instrument Qualification

Seminar Programme as PDF

09.00 – 09.15 h
Welcome and Introduction

09.15 – 10.00 h
Overview: Regulatory Aspects of Instrument Qualification and USP General Chapter <1058>

Overview of regulations including
- Europe: EU GMP Guide - Annex 15
- US: CFR, USP
- ISO 17025:2017
Overview about Qualification steps / Equipment life cycle
Key recommendations of USP General Chapter <1058> and instrument categories
Qualification steps: which activities should be performed in each phase & roles and responsibilities
Change Control & Deviation Management & Documentation

10.00 – 10.45 h
General Aspects of Calibration

Basic concepts, definition, terminology
Uncertainty & traceability in analytical measurement
Calibration issues found during audits and inspections
Handling calibration failures and investigations

10.45 – 11.00 h
Break

11.00 – 12.00 h
Risk Assessment in Analytical Laboratories

Scary examples
Advantages of minimizing risk
Definition and regulation (EU GMP Part 3 - Quality Risk Management, etc.)Approach, applicability, documentation, approvals
FMEA (Failure Mode and Effect Analysis)
HACCP (Hazard Analysis and Critical Control Points)
ISHIKAWA DIAGRAM (Fishbone)
FTA (Fault Tree Analysis)
Risk assessment of changes

12.00 – 12.15 h
Break

12.15 – 12.45 h
Q&A Session 1

12.45 – 13.30 h
Lunch

13.30 – 14.30 h
Qualification of Spectroscopic Instruments and Detectors

Requirements according to USP & Pharm. Eur.
FDA Warning letters and 483 citations
Practical approaches for the qualification and calibration of spectroscopic instruments (UV/VIS, NIR, RAMAN)
Traceability of standards

14.30 – 14.45 h
Break

14.45 – 15.45 h
Qualification of GC Instruments

Warning Letters and Findings
Technical Overview, Applications
From Vendor to Decommissioning: AIQ-LifeCycle
System Suitability Test
Periodic Review (Checklist)

15.45 – 16.00 h
Break

16.00 – 16.30 h
Q&A Session 2

This course is part of the GMP Certification Programme "ECA Certified Quality Control Manager" Learn more

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

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Further dates on-site

Further dates on-site
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Further dates online

Further dates online
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Recording
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Do you have any questions?

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

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Live Online Training: Analytical Instrument Qualification