August - Warning Letter Wednesday (WLW)
How to Prevent FDA Warning Letters and Findings
Join Global Key Solutions Corp. for an engaging session on How to Prevent FDA Warning Letters and Findings. This talk will share practical tips and real examples to help quality leaders stay ready for inspections and keep their operations running smoothly.
We will explore how Advanced Quality Planning (AQP), Failure Mode Effects Analysis (FMEA), and Corrective and Preventive Action (CAPA) work together to prevent compliance issues before they start. Using real FDA warning letter case studies, we will break down how to spot problems early, find their root causes, and put strong prevention and detection measures in place.
You will walk away with:
Clear strategies for building a strong Quality Management System that stands up to inspections
Insights on the most common root causes behind FDA citations and how to avoid them
Proven steps for creating and maintaining an effective CAPA process
Lessons learned from real-world examples that you can apply right away
Guest Speakers:
Daniel Barreto, President and Owner of PharmQ Global Consulting, LLC. Established in 2020, PharmQ specializes in providing strategic, operational, and tactical consulting services to clients in the pharmaceutical industry.
Bill Levinson, Leading expert in lean manufacturing, green supply chains, and statistical process control for nonnormal data, with extensive experience in quality management systems, ISO 9001, and designed experiments. Passionate about improving manufacturing efficiency to boost wages and profits while reducing costs.
Dr. Ligia Zubik, Director of Quality at Global Key Solutions, has over 20 years of experience leading regulatory compliance and inspection readiness at major pharmaceutical companies.
Whether you are preparing for your first inspection or looking to fine-tune your current compliance program, this session will give you the tools and confidence to avoid costly mistakes and protect product quality.
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