How To Validate Your Computerized Systems
In this podcast episode, Daniel Milek, a CSV expert from Data Integral Ltd, provides precious guidance on how you should go about your system validations.
Pharma Trends: The Return of the FDA Warning Letters [Simone Ammons] Simone (George) Ammons
How to Deal With Risk in Pharma Alex Hall
Risk management is a crucial part of the pharmaceutical quality management system. Unfortunately, many companies don’t get it right and don’t understand how to use ICH Q9 correctly.
In this podcast episode, Alex hall explains the right way to approach risk and which tools to use.
Here are some of the discussed topics:
💡 How to use ICH9 appropriately
💡 Tools to identify risks
💡 The first steps in any risk Management
💡 How to design your FMEA scoring system
💡 What is ALARP and how to use it in risk management?
💡 The Biggest Mistake People Do With FMEA
💡 What Are the Tools to Identify Risks?
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Tagged as: ICH Q9, Alex Hall, Risk Management.
Alex entered the Pharmaceutical industry in 1990, starting out in the analytical laboratories before moving into Quality Assurance, working with major pharma companies including Roche, Eli Lilly, and Eisai. She became a Qualified Person (QP) in 2000. During her career, Alex has supported the training and development of QPs both as a member of the Pharmaceutical Quality Group (PQG) committee and during her nine years as a QP Assessor for the Royal Society of Chemistry (RSC). ⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀ www.qpquandary.com ⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀ www.linkedin.com/in/alex-hall-b6851511
In this podcast episode, Daniel Milek, a CSV expert from Data Integral Ltd, provides precious guidance on how you should go about your system validations.
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