Computer Systems Validation (21 CFR Part 11)
This Computer Systems Validation training course is a 2 Day public programme, designed to give attendees the basic principles in validating both computer hardware and software systems used in Manufacturing, QA and Regulatory control of processes and systems.
The Computer Systems Validation Programme will also look at the 21 CFR part 11 ruling by the FDA pertaining to ElectronicRecords / Electronic Signatures.
Regulations and Guidelines for Computer System Validation:
The course will examine the current GAMP version applied to validating PLC, software and control systems. Both FDA and EU regulatory guidelines will be discussed with regard to the Pharmaceutical industry as well as Guidelines issued by the FDA on Software validation in the Medical Device industry
Electronic Signatures and Records:
A discussion on the current 21 CFR part 11 regulations will be given covering topics such as background & impact of the regulations in Industry to date, details of regulations and practical implications of the rule, how to assess relevant company systems/products for compliance and implementing a validation program around a compliant package.
The Computer Validation Life Cycle:
The life cycle from design, through construction, installation and live startup for a typical software project will be described with details on the contents of key documents/activities such as URS, FDS, VMP, IQ, OQ, PQ.
Risk assessment of Computerised systems:
This section will look at the objectives for risk assessment, and will discuss the various techniques and how to effectively implement to ensure critical risks are identified and correct level of validation is carried out.
This Computer System Validation training programme may be of interest to personnel in the Pharmaceutical / MedicalDevice / HealthCare / Engineering Sectors of the Industry who need to gain a solid foundation in the principles of GXP in a regulated environment and how to apply these to develop fully compliant systems.
No prior knowledge of Computer Systems Validation is necessary.
Classroom based, instructor lead, practical hands on course.