Analytical Instrument and System Qualification - An Overview - Online Training Recording
Course No. 23308
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 Managers who 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 Details To participate in an on demand training course, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration When you register for the on demand training course, you can decide at what date you want to follow the training course online. Starting with the access date you entered in the registration process the stream will be available to you for 7 days. Within in this period you can start & stop the stream according to your needs. In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
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