All times mentioned are CEST.
Sprecher
Dr Christopher Burgess, Burgess Analytical Consultancy, UK
Roland Miksche, MiRo Consulting, Austria
Roland Miksche, MiRo Consulting, Austria
Zielsetzung
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
Zielgruppe
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.
Programm
09.00 – 09.15 h
Welcome and Introduction
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
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
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
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
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
Break
16.00 – 16.30 h
Q&A Session 2
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