6-Hour Virtual Seminar on Qualification (IQ, OQ, PQ) and Validation of Laboratory Equipment and Systems for Regulated Industries (Pharma, Biotech, Devices, etc.)

This webinar will aim at understanding and scoping out various phases of Qualification activities that will be integrated with the perspectives of Instrument Control, System Suitability Test (SST), Analytical Methods Validation, and ensuring Data Integrity for Regulatory Compliance.

Agenda:-

Session 1 

• Introduction
• Quality Systems, Paradigm Shift, Global Perspectives
• QA/QC Validation
• Risk Assessment

Session 2 

• Measurement, Resolution, Errors, and Uncertainty
• Regulatory and QS Requirements
• The Product Life-Cycle Concept
• USP chapter 1058
• Examples of Various Systems

Session 3 

• Strategies for Validation
• Documentation /Master Validation Plan

Session 4 

• Training Requirements
• Examples of Various Systems

Why you should attend?

This is an area of growing concern, sometimes ridden with uncertainty as to what needs to be done at each of the stages of the Product Lifecycle. In modern Pharmaceutical and Biotech laboratories, a composite array of various gadgets, devices, analytical instruments, and computerized systems are used daily.

Who Will Benefit?

• Scientists
• Managers
• R&D Personnel
• Quality Assurance / Quality Control Staff
• Validation Managers
• Validation Coordinators
• Production and Process Development Personnel
• Regulatory/Compliance Managers
• Chemists
• Technicians Study Directors(GLP)
• Qualified Persons (EMEA)
• Pharmaceutical Development
• CRO Staff
• CRO Managers, Accredited Laboratories in general
• Anyone engaged with Test Methods