FDA Inspection Readiness Training

Training Duration: 5 days (includes 1 day mock inspection)

Your proficiency in running a smooth inspection is nearly as important as the FDA findings themselves. It is imperative that your team is in place and the logistics are working when you are faced with the FDA inspection. We will meet with your inspection team and review your FDA Inspection procedures. We also provide training for management, subject matter experts and regular staff on how to interact with FDA.

The highlight of this program is the mock inspection which enacts the actual process using ex-FDA investigators. From the moment they walk through the front door until the close out meeting they are simulating the FDA inspection process. An extensive debrief is provided at the conclusion for lessons learned. Our clients have found this to be one of the best investments you can make. The training should be mandatory for all those involved in FDA inspections.

Training Features

This includes ready room personnel, inspection administrators, scribes, subject matter experts and site management.
The course uses unique methods to prepare the facility for inspection which include numerous role-playing activities.
Content focuses on the medical devices and pharmaceutical investigator’s common questions and industry strategies to answer.
Examples of Do’s and Don’ts during the FDA Inspection process.
How to effectible comply with FDA expectations during the investigation process.
Information on what to expect during FDA GMP inspections.

Training Benefits

Employees will have and increase knowledge on how to conduct themselves during the FDA inspection process.
The importance of answering question adequately during the inspection process.
Employee will increase their confidence level during inspection process.
Company increase success to past the inspection.
Minimize FDA observations due to confusion and lack of knowledge.

International Quality Consulting bring a diverse team of consultants to our clients. We are constantly expanding our roster of internationally recognized associates. Our trainers and consultants average over 30 years experience in the FDA regulated environment – many of which are ex-FDA. Our associates bring a wealth of experience to help meet your consulting and training needs.