6th Edition Conference

Reduce Costs for Compliance with Data Integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR

26 - 27 Sep 2019
Philadelphia Airport Marriott, Philadelphia, USA

About Followers 7 Reviews Exhibitors Photos 4 Speakers 1 Travel Deals

"Avoid 483 And Warning Letters"
This Computer System Validation Training course will explore proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. 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. Participants learn how to decrease software implementation times and lower costs using a 10-step risk-based approach to computer system validation.


  • 21 CFR Part 11/Annex 11 - Compliance for Electronic Records and Signatures
  • HIPAA Compliance for Electronic Records, The Five Keys to COTS Computer System Validation
  • Understand what is expected in Part 11 and Annex 11 inspections so you are prepared
  • Learn how to perform risk-based Computer System Validation using fill-in-the-blank templates
  • Understand the responsibilities and specific duties of your staff including IT and QA


8:00 AM - 5:00 PM (Sep 26) (General)
9:00 AM - 3:30 PM (Sep 27) (General)

Entry Fees

Paid Ticket Starts from 1699 USD View Details



5 Exhibitors Estimated Count

Category & Type

Medical & Pharma
IT & Technology


26 - 27 Sep 2019 6th Edition
14 - 15 Sep 2017 5th Edition
08 - 09 May 2017 4th Edition
08 - 09 Sep 2016 3rd Edition
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Different Located Editions
Scottsdale, USA 26 - 27 Feb 2020
San Francisco, USA 20 - 21 Nov 2019


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User Community [ Users who have shown interest for this Event ]

Michele Orosz

Michele Orosz

IT at Zydus

Philadelphia, United States
Ashutos Swain

Ashutos Swain

Marketing Manager at Complianceonline

Palo Alto, United States


Newark, United States
Abdulrahman Alharbi

Abdulrahman Alharbi

Student at SJU

Philadelphia, United States
Stanley Romio

Stanley Romio

Director General at Elim Link

Lagos, Nigeria
Eiman Abdulal

Eiman Abdulal

Student at CHC

Philadelphia, United States
Abdullah Alkhudhayr

Abdullah Alkhudhayr

Philadelphia, United States

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David Nettleton

David Nettleton

FDA Compliance Specialist Sacramento, United States

Visitor Ticket Price

1699 USDAttendee Seminar One Registration
39.877560 -75.244614

Venue Map & Directions

map of Philadelphia Airport Marriott

Philadelphia Airport Marriott

Terminal B, 1 Arrivals Rd, Philadelphia, PA 19153

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