Build continuous inspection readiness for AI-driven regulatory targeting, GMP compliance, data integrity, CAPA effectiveness, and quality culture.
As the FDA increasingly adopts AI-driven risk analysis and advanced compliance monitoring tools to identify high-risk facilities, pharmaceutical and biotech companies must transition from periodic inspection preparation to continuous inspection readiness.
This intensive 2-day virtual seminar provides practical strategies to help organizations prepare for evolving FDA inspection models, data-driven enforcement trends, AI-assisted risk targeting, and increasing regulatory expectations surrounding GMP compliance, data integrity, CAPA effectiveness, and quality culture.
Participants will learn how to strengthen inspection readiness programs, reduce compliance vulnerabilities, and build sustainable systems that support perpetual regulatory readiness.
Head of Quality Assurance, USA | 25+ years of experience
Kelly Thomas is a seasoned Quality Assurance, Quality Control, and Regulatory Compliance leader with 25+ years of experience across API, biologics, medical devices, and combination products. She brings extensive expertise in aseptic and terminally sterilized manufacturing, along with all major dosage forms.
Kelly has a proven track record of leading facility start-ups and successfully managing global regulatory inspections, including FDA and international agencies. She is known for building strong quality systems, supplier management programs, and audit readiness frameworks.
Brings practical, inspection-ready insights to help you strengthen compliance and avoid costly mistakes.
A compact, easy-to-scan agenda covering AI-driven inspection risk, perpetual GMP readiness, regulatory defense, and mock inspection planning.