Pharmaceutical and Biotech laboratories use a multiple array of various gadgets, devices, analytical instruments and computerized systems on a daily basis. Qualification of equipment or ancillary systems are necessary to prove that all critical requirements work as intended and comply with the documentation and procedural requirements. Join this webinar as our presenter Joy takes you through the process of understanding and scoping out various phases of Qualification activities.
This session will also discuss qualification from the perspective of Instrument Control, System Suitability Test (SST), Analytical Methods Validation and ensuring Data Integrity for Regulatory Compliance. FDA inspectional observation and FDA Warning Letter commonly pick up on inadequate qualification or validation. The uncertainty as to what needs to be done at each of stages of the Product Lifecycle can create anxiety for most. This webinar will help you define the step-by-step procedures that are needed to plan and execute validation protocols.
This session will also discuss qualification from the perspective of Instrument Control, System Suitability Test (SST), Analytical Methods Validation and ensuring Data Integrity for Regulatory Compliance. FDA inspectional observation and FDA Warning Letter commonly pick up on inadequate qualification or validation. The uncertainty as to what needs to be done at each of stages of the Product Lifecycle can create anxiety for most. This webinar will help you define the step-by-step procedures that are needed to plan and execute validation protocols.
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
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
