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
Who should Attend
QA
IT
Laboratory staff
QC
Regulatory Affairs
Managers
GMP, GCP, GLP professionals
Past Events
Software Validation for the New FDA Inspections - Electronic Records and Electronic Signatures: From 21 CFR Part 11 to HIPAA 2013 - 05-06 Dec 2013, Mandarin Orchard Singapore (40615)
Software Validation for the New FDA Inspections - Electronic Records and Electronic Signatures: From 21 CFR Part 11 to HIPAA 2026
Important
Please, check "Software Validation for the New FDA Inspections - Electronic Records and Electronic Signatures: From 21 CFR Part 11 to HIPAA" official website for possible changes, before making any traveling arrangements
Event Categories
Education: Training
Government & Global Issues: Law & Regulations
Health & Medicine: Healthcare, Medical laboratories, Medical technology, Pharma
