Computer Systems Validation (21 CFR Part 11)

Course Content:

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.