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Computer System Validation in FDA-regulated Industries

May 2 - May 3

$1195

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.

REGISTER HERE

Details

Start:
May 2
End:
May 3
Cost:
$1195
Event Tags:
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Venue

VALIDATION ASSOCIATES, INC.
305 E. Pennsylvania Blvd.
Feasterville, 19053-7846 United States
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Phone:
+1 215.354.1720