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.
This is an area of growing concern, sometimes ridden with uncertainty as to what needs to be done at each of 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.
Areas Covered in the Session :
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
Who Should Attend:
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
Any one engaged with Test Methods