Compliance Architects® free, downloadable FDA inspection readiness training materials, entitled Survive and Thrive During FDA Inspections, provide best-in-class FDA inspection management approaches, tips and secrets from some of the world’s top companies. New and updated for 2018 and beyond, these inspection training materials were compiled and developed by leading FDA compliance and enforcement experts Jack Garvey and Teresa Gorecki, and reflect decades of hands-on experience directing, managing and supporting FDA inspections and obtaining successful inspection outcomes.
Compliance Architects® also offers in-person training sessions using these materials at your site. Get your team trained by the best – let us know on the download form that you are interested in on-site training delivered by our FDA inspection experts, Jack and Teresa.
These free online materials are available ONLY to individuals employed by companies directly regulated by the US Food and Drug Administration, i.e., pharmaceutical, medical device, dietary supplement, biologic, food, cosmetic, etc.
In order to access the free training materials, we require your business contact information. Upon verification of information provided, and eligibility, you will receive an email at your company email address providing access to the training materials.
We are confident the principles you and your team learn from these materials will greatly increase your chances for successful FDA inspection outcomes!
Compliance Architects® free training materials cover the following topics:
- “FDA 101”; the Basis of the Regulations
- Regular Readiness / Preparation for Today’s FDA Inspections
- Directing / Leading the Inspection:
- Inspection Management
- Logistics / Back Room vs. Front Room
- Investigator Tactics
- Response Dos and Don’ts