Dr Karl-Heinz Bauer
Training - Beratung - Coaching (form. Boehringer Ingelheim)
Referent:innen
Zielgruppe
This Live Online Training is designed for Analysts, Laboratory Managers, Laboratory Scientists and QC/QA Managerswho are working in pharmaceutical companies or service laboratories dealing with equipment qualification and computer system validation or are accountable equipment managers.
Additionally, the training is also addressed to employees at qualification and validation service providers and manufacturers of analytical instruments for the pharmaceutical Industry.
Additionally, the training is also addressed to employees at qualification and validation service providers and manufacturers of analytical instruments for the pharmaceutical Industry.
Zielsetzung
This Live Online Training is intended to provide guidance on a state-of-the-art Analytical Instrument Qualification in QC laboratories according to the current guidelines and regulations.
Programm
Computer-based Systems & Regulatory Requirements Part I & Part II: USP <1058> „Analytical Instrument Qualification“, EU GMP Guideline: Annex 11 „Computerized Systems“ & CFR 211 Part 11: „Electronic Records and Signatures“
- Equipment groups A, B and C of USP <1058>
- Integral approach for equipment qualification and computer system Validation
- Electronic Records and signature requirements
- Open and closed Systems
- Control of codes, passwords and authentication
- Disaster recovery planning
Practical Example for an Analytical Instrument Qualification: Analytical Balance
- Design Qualification (DQ), User Requirement (URS)
- Risk Assessment (RA, QRM)
- Installation-(IQ), Operational- (OQ) and Performance Qualification (PQ) test cases
- Protocol and report formats and design
Requirements and Basics of GAMP & CSV
- The GAMP Guide at a glance
- Terms and definitions
- Software categories according to GAMP 5
- Core elements of a holistic approach
- Life Cycle Concept / V-Model
- Software features & types
- Functional requirements
- Computer system validation measures in the operational phase of computerized systems
- Data integrity (ALCOA), data security, disaster recovery management
- Supplier participation
Practical Exercise: Qualification Planning for a Computer-based System (Analytical Balance connected to a LIMS)
- Connection of an analytical balance and LIMS
- Key elements and success factors
- Pitfalls
Analytical Instruments and Computerized Systems
- Chromatographic methods (HPLC, GC, FT IR, FT NIR)
- pH meter, conductivity meter
- Refractometers, polarimeters
- Particle measuring device, microscope
- Thermometer, melting point device
- Breaking forth of tablets
- Titration
Weitere Informationen
Technical Requirements
We use Webex for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-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.
Fees (per delegate plus VAT)
ECA Members € 1,090
APIC Members € 1,190
Non-ECA Members € 1,290
EU GMP Inspectorates € 645
The fee is payable in advance after receipt of invoice.
Presentations/Certificate
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language
The official conference language will be English.
Contacts:
Questions regarding content:
Ms Anne Günster (Operations Director), +49(0)62 21 84 44 50, guenster@concept-heidelberg.de
Questions regarding organisation:
Ms Sonja Nemec (Organisation Manager), +49(0)62 21 84 44 24, nemec@concept-heidelberg.de
Datum & Uhrzeiten
Wed, 14 October 2026, 9:00 – approx. 16:00 h
All times mentioned are CEST.
All times mentioned are CEST.
Teilnahmegebühr
| ECA-Member*: | € 1090,- |
| Regular Fee*: | € 1290,- |
| EU/GMP Inspectorates*: | € 645,- |
| APIC Member Discount*: | € 1190,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
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Aufzeichnung/weitere Termine nicht verfügbar
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E-Mail: info@concept-heidelberg.de
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