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Joy McElroy
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Qualification (IQ, OQ, PQ) and Validation of Laboratory Equipment and Systems for Regulated Industries 2022 - 6-Hour Virtual Seminar on

6-Hour Virtual Seminar on Qualification (IQ, OQ, PQ) and Validation of Laboratory Equipment and Systems for Regulated Industries 2022

Product Id : MD3056
Category : Clinical & Laboratory, FDA Compliance, Food, Drugs & Biologics, Medical Devices, Quality, Virtual Seminars
Presenter : Joy McElroy
Scheduled On : April 25 2022 10:00 am US/Canada (Eastern Time - ET)
Duration : 6 Hours

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.

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:

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

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World Medical Events Company
12922 SE 299th Street, Auburn WA 98092 USA