2-day In-person Seminar on âSoftware Validation for the New FDA Inspections - Electronic Records and Electronic Signatures: From 21 CFR Part 11 to HIPAA" at Singapore

About This Activity


  1. This course will teach you how to reduce software validation costs by as much as two thirds.
  2.  It details all the requirements for 21 CFR Part 11 and HIPAA that relate to SOPs, software features, and risk-based validation
  3. The course is highly interactive, using real life examples and proven techniques
  4. You will learn how to use electronic records and electronic signatures to maximize productivity.
  5. This course will teach you how to prepare for an audit and is intended for IT, QA, laboratory, clinical, and manufacturing staff, as well as software vendors.
  6. The instructor starts with the basics and covers advanced concepts such as how to "Right size" change control methods that allows quick and safe system revalidation.
  7. Learn how to reduce testing time, and how prepare documents that avoid 483s and warning letters.

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