Inspection Readiness

Inspection Readiness Training

Ensuring a successful inspection, from small business distributors to well-established global sponsors and manufacturers alike, requires preparation and an understanding of industry practices. This informational course provides an overview of regulatory inspection processes, targeted industry-specific guidance, and important references and links to regulations and guidelines that will allow your team to prepare for regulatory authority inspections (including the FDA and European Medicines Agency).

Over 14 weeks, those taking the course will learn details from industry experts and former regulatory authority personnel on what to expect during an inspection and how to maneuver to a successful closing meeting and beyond. This is an excellent program for establishing a broader knowledge-base on expectations, preparing procedures, communication strategies, and maintaining control over the inspection process.

Who Should Take This Course

Those involved in regulatory inspections and those preparing for an inspection in the pharmaceutical, biotechnology, medical device, or biologics industry would greatly benefit from this program. This course provides soft skills for improved site-inspector communication and common terminology used by regulatory authorities when addressing outcomes and enforcement. At the end of this course, professionals will have gained knowledge of regulations and guidance impacting inspections, compliance and enforcement, as well as soft skills, industry standards, and terminology involved in inspection.