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Training Strategy & Consulting
21 CFR Part 11 and Annex 11; What you Need to Know to Pass the New Regulatory Audits
Product Id: 600507
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Duration: 90 Minutes
This webinar details both regulations and provides details for implementing computerized systems.
Learn exactly what is needed to be compliant for all three primary compliance areas: SOPs for the IT infrastructure, industry standards for software product features, and the 10-step risk-based validation approach. This webinar demystifies Part 11 and the new European equivalent Annex 11. It gets you on the right track for using electronic records and signatures to greatly increase productivity.
Areas Covered in the Session:
Which data and systems are subject to the regulations?
What the regulations mean, not just what they say.
Avoid 483 and Warning Letters.
Examine the regulatory requirements for the three primary areas of Part 11 compliance: SOPs, software product features, and validation documentation.
Ensure data integrity, security, and protect intellectual property.
Understand the current computer system industry standards for security, data transfer, and audit trails.
Electronic signatures, digital pens, and biometric signatures.
Evaluate the regulatory requirements related to the current computer system standards for security, data transfer, audit trails, electronic signatures, digital pens, and biometric signatures.
SOPs required for the IT infrastructure.
Product features to look for when purchasing COTS software.
Reduce validation resources by using easy to understand fill-in-the-blank validation documents.
Who Will Benefit:
GMP, GCP, GLP professionals