This 2-day seminar includes an overview of validation tasks required by FDA Regulations and Guidelines.
The course content goes beyond simply “what” needs to be done – the emphasis is on “how” to accomplish computer system validation tasks.
The workshop format promotes hands-on, practical learning. Participants learn:
A Validation Process that addresses Regulatory Requirements and Guidelines for Computer System Validation
Regulatory action taken for non-compliance to Validation Requirements (483s & Warning Letters)
Risk Management Activities
How to develop and execute a Validation Plan
How to perform and document Validation Tasks
How to assess Software Development Activities for various types of software, and the impact of the development activities on the validation process
How to develop, complete, and document Test Activities
How to summarize, assemble, package, and maintain Validation Documentation
The Registration Fee includes attendance both days, continental breakfasts, lunches, and breaks, an attendee binder containing slides, handouts, and activities, and 30 minutes of follow-up validation consulting.