WCS Consulting Inc.3190 Stirling Rd, Unit K4 ,Hollywood, FL 33021,

Hollywood,

FL,

US,

ZIP: 33021

Phone: 844-267-7299 | 954-947-5671  

Overview
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.
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 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.

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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

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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
• Any one engaged with Test Methods

Speaker Profile

Joy McElroy Upon earning a degree in Zoology at North Carolina State University, She made her debut in the pharmaceutical industry in 1992 at Pharmacia & UpJohn performing Environmental Monitoring and Sterility Testing.

Wcs Seminars
Registration Details
(Contact us : 844-267-7299 | 954-947-5671  
Don't wait. Register TODAY or  Email  US [email protected]