Computer Systems Validation
ObjectivesThis 2 day course will give attendees a grounding in the principles of Computer Systems Validation, Software Validation, and the latest requirements for Electronic Records and Electronic Signatures. The course covers the application of European and FDA requirements to the validation of both computer hardware and software systems used in Manufacturing, QA, Regulatory and the Control of Processes. The latest FDA Requirements and Guidance on Electronic Records and Signatures (21 CFR Part 11) and Quality Risk Management as
applied to Software Validation and Computer Systems Validation are also covered.
Content includesLaws, Regulations and Guidelines for Computer Systems and Software Validation
- The Software Validation Life Cycle
- Electronic Signatures and Records
- Risk Assessment
What will I learn?
- Apply the principles of Software Validation and Computer Systems Validation.
- Implement the Validation Life Cycle approach to software and computer systems
- Apply Quality Risk Management techniques.
- Generate key validation documents such as URS, FDS, VMP, IQ, OQ and PQ.
- Apply the requirements of 21 CFR part 11 in relation to Electronic Signatures & Records.
Who should attendPersonnel in the Pharmaceutical/Medical Device/Healthcare sectors who need to gain a solid foundation in the principles of Computer Systems Validation in a regulated environment.
Online - virtual classroom, Online
06 - 07 October 2021 (Virtual Classroom)