22/08/2016 - 24/08/2016
Training Computer validation for Lab systems
22/08/2016 - 24/08/2016 All Day
1. Goal of the training
This interactive course is designed to provide you with the knowledge & skills to achieve an effective Lab system validation for computerized high-end-lab systems. Through this training you will receive an overview of the various aspects of computer validation methodology including best practices, regulations and Industry standards. It addresses also practical techniques & documents to develop and implement.
2. Regulations considered
FDA 21 CRF ; Part 11 EU GMP Annex 11 & Ch.4: Documentation ; ISPE GAMP 5
3. Added value
Practical training given by Ioan Tibeica, an expert with experience in various domains of computer validation. The participants will gain sufficient background and tools to work with. During training practical cases and questions can be discussed. Extra coaching can be planned to discuss the trainee experiences and hazards in the field.
At the end of the course participants will be able to
- Interpret the FDA 21 part 11, GAMP, ICH, requirements for software and electronic records and translation into in specific validation test protocols.
- Interpret GAMP principles (for electronic data and software) related to lab systems and how they can be tested during validation.
- Know the critical points in validation of Lab systems & computerized high-end lab systems.
- Know the critical points in data integrity requirements concerning electronic records & electronic signatures.
- Practice V-model for Lab system validation.
- Know how to reduce cost in the validation for example
by supplier involvement or comparison of systems.
- Practice QRM for Lab systems.
- Know the critical points in the documentation.
- Know how to set-up routine validation during the total
CSV for Lab systems (LIMS, ECM) & computerized high-end lab systems (HPLC, GC…).
Location: To define
Data: 22 – 23 – 24 August 2016
Trainer: Ioan Tibeica
- EU/FDA requirements regarding current good practices (CGXPs)
- System Development Lifecycle (SDLC) for Lab System
- Quality Risk Management
- Electronic Records Electronic Signatures 5. Project Deliverables
- Theoretical knowledge
- Exercises, workshops & test
- Community of practice
- Come back session after 1 month to discuss the implementation from what they have learned
People with limited experience in CSV and basic understanding of V-Model.
- Developers of computer system applications
- Users of computer system involved in testing and validation activities
- Personnel involved in computer system procurement/supplier audit.
- All concerned managers, auditors and regulatory
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Bookings are closed for this event.