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.
Webinar Takeaway
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
Industries who can attend
This 360 -minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.
Faculty Joy McElroy
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. Her hard work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw their Quality Control Lab. In 1998 Joy moved to Wyeth Lederle and worked in Quality Assurance, performing GMP Compliance audits, batch record reviews, and holding annual GMP training for new employees. After working in Quality Assurance for a few years, Joy moved into Equipment Qualification and Cleaning Validation at Mallinckrodt.
