Lack of proper system validation is one of the major reasons for warning letters and 483s (http://www.complianceonline.com/
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Seminar instructor David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. He has completed more than 196 mission critical laboratory, clinical, and manufacturing software implementation projects.
During the two day interactive seminar, Mr. Nettleton will discuss proven techniques for reducing costs and time associated with computer system implementation and maintenance in regulated environments. He will explain the latest computer system industry standards for data security, data transfer and audit trails with a 10-step risk-based approach to computer system validation. The seminar will give the attendees an understanding of how 21 CFR Part 11 and HIPAA electronic security regulations for patient medical records fit into the validation process. He will also discuss recent FDA trends and how to streamline SOP authoring, revision, review, and approval.
The seminar will be beneficial for regulatory, clinical and IT professionals working in healthcare, clinical trial, biopharmaceutical and medical device sector that uses computer systems to perform their job functions. It will provide valuable guidance to Regulatory Affairs personnel, OA/QC personnel, IT/IS personnel, Software Managers, Project Managers, Software vendors and suppliers on effective computer system validation.
Date: Thursday, February 7 and Friday, February 8, 2013, 8.30 AM- 4.30 PM MST
Venue & Location: Courtyard Phoenix Camelback, AZ
Registration Cost: $1,299.00 per registration
Early bird discounts: For discounts on early registrations, please Click here .
Register by phone: Please call our customer service specialists at +1-650-620-3937 or email to customercare@
For more information on ComplianceOnline or to browse through our trainings, please visit our website
ComplianceOnline is a leading provider of regulatory/compliance trainings for companies and professionals in regulated industries. ComplianceOnline has successfully trained over 20,00 professionals from 3,000 companies to comply with the requirements of regulatory agencies. ComplianceOnline is headquartered in Palo Alto, California and can be reached at http://www.complianceonline.com/?
For more information please contact:
A Reuben Bernard
Manager of Program Marketing
2600 E Bayshore Rd
Palo Alto CA USA 94303