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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
Start: Thursday, December 5, 2013 @ 9:00 PM (+00:00)
Mandarin Orchard Singapore 333 Orchard Road
- This course will teach you how to reduce software validation costs by as much as two thirds.
- Â It details all the requirements for 21 CFR Part 11 and HIPAA that relate to SOPs, software features, and risk-based validation
- The course is highly interactive, using real life examples and proven techniques
- You will learn how to use electronic records and electronic signatures to maximize productivity.
- 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.
- 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.
- Learn how to reduce testing time, and how prepare documents that avoid 483s and warning letters.