Analytical Instrument and System Qualification - An Overview - Live Online Training
Wednesday, 14 October 2026 9 .00 - 16.00 h
Course No. 22737
Speakers
Dr Karl-Heinz Bauer
Training - Beratung - Coaching (form. Boehringer Ingelheim)
Target Group
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.
Objectives
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.
Programme
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
Further Information
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
Date & Time
Wed, 14 October 2026, 9:00 – approx. 16:00 h All times mentioned are CEST.
Testimonials
