2-day In-person Seminar: Computer System Validation - Reduce Costs and Avoid 483s By David Nettleton (21 CFR Part 11 Compl)

Venue: Sheraton San Diego Hotel & Marina

Location: San Diego, California, United States

Event Date/Time: Jun 16, 2011 End Date/Time: Jun 17, 2011
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Nearly every computerized system used in laboratory, clinical, manufacturing settings and in the quality process has to be validated. Finding efficiencies without weakening the quality position is essential.

This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Attendees learn how to decrease software implementation times and lower costs using a 10-step risk-based approach to computer system validation.

The instructor addresses the latest computer system industry standards for data security, data transfer, and audit trails. Students see how 21 CFR Part 11, the FDA regulation pertaining to use of electronic records and signatures, and the HIPAA electronic security regulations for patient medical records fit into the validation process. Finally, the instructor reviews recent FDA inspection trends and discusses how to streamline SOP authoring, revision, review, and approval.

This course benefits anyone that uses computer systems to perform their job functions and is ideal for regulatory, clinical, and IT professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors.

Course Objectives:

Implement a computer system to gain maximum productivity and reduce cost by as much as two thirds
Quickly cross train workers and see how to make use of temporary workers and outsourcing to promote growth and reduce costs
"Right size" change control methods that allows quick and safe system evolution
Minimize the validation documentation to reduce costs without increasing regulatory or business risk
Write test cases that trace to elements of risk management
Protect intellectual property and keep electronic records safe


1380 Harbor Island Drive
San Diego
United States