How to Conduct a Human Factor Analysis of Instructional Documents, Particularly Master Batch Records (MBR) and Standard Operating Procedures (SOP) 2016

Topics

• Top Ten FDA Audit Findings
• Human Factors
• Readability/Usability of Instructional Documents, such as standard operating procedures (SOP) and batch records; master batch record/production batch record (MBR/PBR)
• 21 Code of Federal Regulations (CFR) Part 210; 21 Code of Federal Regulations (CFR) Part 211
• Document management system
• Systematic monitoring of effective human factoring analysis of instructional documents by other quality systems

Who should Attend

• Instructional Document Author, Reviewer, Approver
• Leadership Role (regardless of level within organization)
• Continuous Improvement Role
• Document Management Staff
• Manufacturing Operation / Production Staff
• Auditor Role
• Safety Staff
• Training Staff