Pharma Webinar | Live July 14th Highlighting Quality Assurance from Auditor’s Viewpoint
Guest experts:
Gael Love, Director/QA Consultant, Love CQA Ltd
John Parker, Director/Principal Consultant, ClinPark QA Ltd
Shailesh Karavadra, Applications Manager, Thermo Fisher Scientific
Tactic: Live webinar with EPR
When: Wednesday, July 23, 2021, at 9:00am CDT
Topic: Improving quality of bacterial culture and oligonucleotides with UV/Vis spectroscopy to accelerate mRNA vaccine production
Overview: In this webinar, hear directly from industry auditors as they discuss the current regulatory framework for good manufacturing practice (GMP), including data integrity, validation and qualification for computerized systems in regulated laboratories. Learn how these systems are implemented in a laboratory setting and the key aspects that an auditor would scrutinize during an audit. The experts will also review Thermo Fisher Scientific’s Spectroscopy Software solutions to highlight their compliance with even the most stringent regulatory requirements.
Key learning objectives:
- Identify the key GxP regulatory requirements that impact use of computerized systems and analytical instruments in laboratories conducting regulated work
- Understanding the requirements of laboratory systems with respect to validation/qualification
- Learn how to identify and control risks to the integrity of data
- Understand compliance risks associated with electronic systems
Who should attend:
- Procurement personnel in companies supporting or conducting GxP activities
- CSV, Analytical system administrators or IT personnel working in a GxP environment
- Analytical management and scientists working in GXP
- Quality Management
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