DATE/TIME
September 25, 09:00 – 09:30 AM EST
TITLE
FDA Inspection Trends and Top Citations: A Focus on Facilities and Engineering
SPEAKER
Patrick Day, Principal Consultant, Lachman Consultants
ABSTRACT
FDA inspection activity continues to evolve, and the agency’s expectations for the physical plant are rising with it. This annual review examines the most recent inspection data — Form 483 observations, warning letters, and enforcement trends with a focus on facilities and engineering: aging infrastructure, utilities and water systems, HVAC and environmental controls, equipment qualification and maintenance, and cross-contamination risks. Special attention is paid to findings most relevant to contract manufacturers, where multi-product facilities and client-driven changes create unique compliance challenges. Attendees will leave with a clear picture of what investigators are citing today and how facility-related observations escalate into enforcement.
BIO
Pat is an established pharmaceutical executive and practitioner with proven leadership in proactive risk identification, deployment of strategies to enhance compliance controls, and implementation of detection systems to eliminate blind spots. He is skilled in policy deployment, Facility Management Compliance, Computer System Validation, Data Integrity/Governance, Risk Management, Supply Chain Logistics and application of AI for the next generation of quality professionals. He has trained FDA field inspectors for the physical facility inspection techniques and has delivered talks on deployment of risk strategies and modern signal detection. His expertise also includes outsourcing and integrating efficient governance of Facilities Management and laboratory services across US/UK and Asia-Pacific. Pat’s frequent blogs and articles help educate the industry become aware of emerging global risks, technologies, and their effect on the global supply chain.
