21 CFR Part 11 and Annex 11; What you Need to Know to Pass the New Regulatory Audits October 2012

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