Validation, GAMP and 21CFR11

Validation is according to the FDA 'the set up of documented prove that in high extent insures that a specific trial will be produced on consistent manner a product according to of too in front fixed specifications and qualities'. Automations systems cannot be tested on the same manner as physical products. GAMP offers a manual for development of validation processes for control systems.

The '21 Code of Federal Regulations, Part 11' is a regulation of the FDA with regards to electronic records and signatures. It describes which controls and procedures must be exported on information which are contained in an electronic way and on electronic documents that become used instead of signed paper documents. Next to theory, a risk assessment workshop is a part of the course.

Purpose

Understanding of specific requirements for production in industries which belongs to the rules of the FDA
Know the requirements for valided systems
Understanding the GAMP guidelines for processes for use in specification, installation and qualification of validaded systems
Understanding the relations between GAMP and software development life cycles
Understanding the requirements for management of electronic records and for the creation and management of documents with an electronic signature
Know a recovery method to develop compliancy with 21 CFR part 11

Length

2 days

Investment

€ 995,- p.p. excl. BTW, inclusive materials and lunch.

Course data & times

16, 17 September 2010 (thu, fri), 9.00 - 16.30
11, 12 November 2010 (thu, fri), 9.00 - 16.30