Computer System Validation - Reduce Costs and Avoid 483s

Venue: Scottsdale, AZ

Location: Scottsdale, AZ, Arizona, United States

Event Date/Time: Feb 06, 2014 / 8:30 am - (GMT +5:30 hours) End Date/Time: Feb 07, 2014 / 4:30 pm - (GMT +5:30 hours)
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Computer System Validation - Reduce Costs and Avoid 483s To be held on 6th to 7th Feb 2014 at Scottsdale, AZ    Significant changes in the regulations and industry standards for software validation are detailed in this interactive two-day course. The instructor addresses the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation related to FDA 21 CFR Part 11, European Annex 11, and HIPAA electronic security regulations for patient medical records.    Today the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements and companies must update their systems and processes to maintain compliance.    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 explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Students learn how to decrease software implementation times and lower costs using a 10-step risk-based approach to computer system validation. 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.    Learning Objective:    Understand what is expected in Part 11 and Annex 11 inspections  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    For more information kindly visit :    Or    Contact us at :    Company Profiles And Conferences  Mob +919223375060 / 919223767111  Fax : +91 22 27810778  E-mail :  Website :


Scottsdale, AZ
United States

Conference Speakers

David Nettleton FDA Compliance Specialist, Computer System Validation 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. His most popular book is Risk Based Software Validation - Ten easy Steps (Davis Horwood International and PDA -, 2006) which provides fill-in-the-blank templates for completing a COTS software validation project.