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1st Edition  Conference

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


"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.

Highlights

  • Learn how to use electronic records and electronic signatures to maximize productivity
  • 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
  • Minimize validation documentation to reduce costs without increasing regulatory or business risk
  • Learn how to reduce testing time and write test cases that trace to elements of risk management

Timings

8:00 AM - 5:00 PM (Nov 20) (General)
9:00 AM - 3:30 PM (Nov 21) (General)

Entry Fees

Paid Ticket Starts from 1699 USD View Details

Participants

20
Delegates

5 Exhibitors Estimated Count

Category & Type

Conference
Medical & Pharma
IT & Technology

Editions

20 - 21 Nov 2019 1st Edition


Frequency Quarterly
Next edition likely in Feb 2020

Official Links

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ComplianceOnline USA

Top Rated 356 events listed

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Speakers

Speaker
David Nettleton

David Nettleton

FDA Compliance Specialist

Visitor Ticket Price

1699 USDAttendee Seminar One Registration
37.775000 -122.419000

Venue Map & Directions

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Venue to be announced

San Francisco, USA

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