Course "Software Validation for the New FDA Inspections" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
- This course will teach you how to reduce software validation costs by as much as two thirds.
- 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.
Who Will Benefit:
- Laboratory staff
- Regulatory Affairs
- GMP, GCP, GLP professionals