Manufacturing food and drugs in the United States requires strict compliance with regulations set by the Food and Drug Administration (FDA). From facility registration to Good Manufacturing Practices (GMP), labeling, inspections, and post-market responsibilities, FDA compliance affects every stage of the manufacturing process.
This course provides a thorough, real-world roadmap for navigating FDA regulations for both food and drug manufacturing. Participants will learn how to build and maintain FDA-compliant systems, avoid enforcement actions, prepare for inspections, manage recalls, and operate legally and efficiently.
It’s designed for manufacturers, importers, compliance officers, quality managers, legal teams, and anyone responsible for regulatory operations.
Course Objectives
By the end of this course, participants will be able to:
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Identify and interpret FDA regulations applicable to food and drug manufacturing.
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Understand and implement Good Manufacturing Practice (GMP) and related standards.
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Comply with facility registration, recordkeeping, labeling, and reporting requirements.
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Prepare for and manage FDA inspections, warning letters, and enforcement actions.
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Design systems that meet FDA expectations for sanitation, quality control, and traceability.
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Handle recalls and adverse event reporting effectively.
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Integrate FDA compliance into everyday operational processes.
