Software Validation for the New FDA Inspections - Electronic Records and Electronic Signatures: From 21 CFR Part 11 to HIPAA 2013 is a course that covers topics such as:
- Requirements for 21 CFR Part 11 and HIPAA that relate to SOPs, software features, and risk-based validation
- How to reduce software validation costs by as much as two thirds
- How to prepare for an audit and is intended for IT, QA, laboratory, clinical, and manufacturing staff, as well as software vendors
- How to use electronic records and electronic signatures to maximize productivity
- How to reduce testing time
- How to "Right size" change control methods that allows quick and safe system revalidation
- How prepare documents that avoid 483s and warning letters
Software Validation for the New FDA Inspections - Electronic Records and Electronic Signatures: From 21 CFR Part 11 to HIPAA 2013 is intended for:
- QA
- IT
- Laboratory staff
- QC
- Regulatory Affairs
- Managers
- GMP, GCP, GLP professionals
