Reduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR

Website https://www.complianceonline.com/computer-system-validation-reduce-costs-and-avoid-483s-seminar-trai | Edit Freely

Category pharmaceutical; Medical Devices; All FDA regulated Industries; Health Care

Deadline: February 04, 2026 | Date: February 04, 2026-February 05, 2026

Venue/Country: U.S.A

Updated: 2025-11-06 16:28:55 (GMT+9)

Call For Papers - CFP

Learning Objectives:

Reduce costs, usually by two-thirds, for compliance with electronic records

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

Avoid 483 and Warning Letters

Understand the responsibilities and specific duties of your staff including IT and QA

Understand your responsibilities and liabilities when using SaaS/cloud

Learn how to perform risk-based Computer System Validation using fill-in-the-blank templates

How to select resources and manage validation projects

"Right size" change control methods that allows quick and safe system evolution

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

Learn how to comply with the requirements for data privacy

Learn how to buy COTS software and qualify vendors

Protect intellectual property and keep electronic records safe