Quality is always the result of excellent work without compromise.
MMD-108 US FDA Inspection Readiness
Schedule and Hours
The US Food and Drug Administration (FDA) conducts inspections of regulated facilities to determine compliance with applicable laws and regulations, such as the Food, Drug, and Cosmetic Act as well as related Acts. Such inspections extend to foreign manufacturing and processing sites for FDA-regulated products that are sold in the United States.
These inspections can either be a pre-approval inspection pursuant to an application to market a new product, or a routine inspection, or “for-cause”. Inspection observations may result in Warning Letters which could further escalate in automatic detention or even facility deregistration. It is therefore imperative that besides being consistently in compliance & ready for an inspection at any time, facility personnel must know what they are allowed & not allowed to answer; when they should defer questions to their supervisor; and which locations & information they are obliged to allow access to the FDA investigator.
Participants will be led by an experienced trainer whom, in addition to being a CE Marking auditor, technical file reviewer and a trained MDSAP auditor, has nearly 3 decades of assessment, training and quality assurance as well as management system development experience. The trainer has also performed Regulatory Authority Inspections in addition to FDA Mock Inspections. Participants will be in a position to gauge the readiness of the plant and to plan for & manage the FDA inspection.
Participants will gain a thorough understanding of:
The purpose and types of FDA inspections
The Regulatory Requirements and Guidelines relevant to inspections
FDA Audit terminology
Effective personnel management during the inspection
US FDA Inspection Program and Quality Systems Inspection Technique
Types of FDA Inspections
Preparing & Passing FDA Inspections
Proper manner to interact with FDA Investigator
Roles & Responsibilities
Post inspectional correspondences & other activities
FDA Warning Letters Trends
The Site Inspection Readiness Team whom will be hosting, supporting & engaged in the Inspection, including: