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6-Hour Virtual Seminar on Qualification (IQ, OQ, PQ) and Validation
Date
Oct 11, 2021 - 11:00 AM
- Oct 12, 11:00 AM
Organizer
WCS
Venue
online
Location
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.
• 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 Will Benefit
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.
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 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 Details
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]
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]
Event Categories
Keywords: pharmaceutical