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Computer System Validation - Reduce Costs and Avoid 483s

Computer System Validation - Reduce Costs and Avoid 483s

Course Number: 062120122
Description:

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.

Audience: Regulatory Affairs , QA/ QC , IT/IS , Software managers, Project managers, Software vendors and suppliers .
RAC Points: 12
Start Date: Thursday, June 21, 2012 8:30 AM
End Date: Friday, June 22, 2012 4:30 PM
Location: San Diego , CA, USA
Registration: Open Enrollment
Delivery: Face-to-face event
Cost: $1,299.00
Objectives:
Course Web Site: http://www.complianceonline.com/ecommerce/control/seminar?product_id=80005SEM&channel=small-banner

Provider: ComplianceOnline
Yazdan Fraz
2600 E. Bayshore Road
Palo Alto, CA
USA , 94303
Phone: 650-620-3972
Fax: 650-963-2556
Email: customercare@complianceonline.com
Website: www.complianceonline.com

ComplianceOnline is the one-stop information source for compliance and quality professionals on the web. ComplianceOnline provides online training, digital products and other services. With our wide range of topics and course modules, we have become a trusted source for professionals seeking information, best practices, training products and tools on corporate governance, risk management, regulatory compliance and quality management.