21 CFR Part 11 and Annex 11; What you Need to Know to Pass the New Regulatory Audits October 2012
02 Oct 2012
Webinar
Key Topics
Regulations meaning
Data and systems relevant to the regulations
Regulatory requirements of Part 11 compliance: software product features, SOPs and validation documentation
And warning Letters avoidance
Current computer system industry standards for data transfer, security and audit trails
Security, data integrity and protection
Regulatory requirements related to computer system standards for data transfer, security, electronic signatures, audit trails, biometric signatures and digital pens
Digital pens, Electronic signatures and biometric signatures
Product features to look for when purchasing COTS software
SOPs required for the IT infrastructure
Validation resources reduction by using easy to understand fill-in-the-blank validation documents
21 CFR Part 11 and Annex 11; What you Need to Know to Pass the New Regulatory Audits is recommended for:
QA
IT
Laboratory Staff
QC
GMP, GCP, GLP professionals
Managers
Past Events
21 CFR Part 11 and Annex 11; What you Need to Know to Pass the New Regulatory Audits October 2012 - 02 Oct 2012, Webinar (32885)
21 CFR Part 11 and Annex 11; What you Need to Know to Pass the New Regulatory Audits 2012 - 01 May 2012, Webinar (17827)
21 CFR Part 11 and Annex 11; What you Need to Know to Pass the New Regulatory Audits 2026
Important
Please, check "21 CFR Part 11 and Annex 11; What you Need to Know to Pass the New Regulatory Audits" official website for possible changes, before making any traveling arrangements
Event Categories
Government & Global Issues: Law & Regulations
Health & Medicine: Healthcare, Medical laboratories, Medical technology
Technology: Information Technology (IT), IT Security, Software engineering
