21 CFR Part 11 and Annex 11; What you Need to Know to Pass the New Regulatory Audits is a webinar that covers topics such as:
- 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