Understanding and Implementing USP [1058]: Analytical Instrument Qualification 2018

Topics

• Discuss appropriate equipment classification assignment and Failure Mode and Effect Analysis
• The Validation Plan and compliance requirements – what, why, who, when, where
• Calibration, DQ, IQ, OQ, PQ, PT, system suitability and system validation requirements
• Differentiate between calibration, qualification and validation
• Supporting data, documentation and record storage
• The qualification process and responsibilities
• Implementation, practice, preventative maintenance, requalification / validation

Who should Attend

• QA Managers and Personnel
• QC Managers, Supervisors and Analysts
• R&D Managers, Supervisors and Analysts
• Regulatory and Compliance Professionals
• Metrology
• IT/IS Managers and System Administrators
• Training departments
• Validation Specialists
• Consultants