21 CFR Part 11: Electronics Records and Signature

Course Overview: This course is designed to provide a comprehensive understanding of Title 21 CFR Part 11, a set of regulations issued by the Food and Drug Administration (FDA) governing electronic records and electronic signatures in the pharmaceutical industry. Participants will gain knowledge of the key requirements, compliance strategies, and best practices for implementing and maintaining compliant electronic systems. Target Audience: + Quality Assurance and Quality Control personnel + Regulatory Affairs professionals + IT professionals + Validation engineers + Management personnel in pharmaceutical and medical device industries Course Objectives: Upon completion of this course, participants will be able to: + Understand the key principles and requirements of Title 21 CFR Part 11 + Identify the critical control points for compliance + Develop and implement effective compliance strategies + Conduct risk assessments and validation activities + Write and review standard operating procedures (SOPs) + Perform audits and inspections to ensure compliance + Respond to FDA inspections and audits