Compliance Architects® now offers free, instructor-led, online training in FDA inspection readiness to eligible life sciences companies. Entitled Survive and Thrive During FDA Inspections, this one-hour plus program provides industry-proven best practices for FDA inspection management and includes approaches, tips and secrets from some of the world’s top companies. New and updated for 2020 and beyond, these inspection training materials were 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 contact form that you are interested in on-site training delivered by our FDA inspection experts, Jack and Teresa.
Free online training is available only to individuals employed by companies directly regulated by the US Food and Drug Administration, or other internationally-regulated life science entities, i.e., pharmaceutical, biopharmaceutical, medical device, dietary supplement, biologic, food, cosmetic, etc.
To register for this free training we require your business contact information. Upon verification of information provided, and eligibility, you will receive an email at your company email address with a request for additional information, request for suitable dates and times, and terms and conditions for the training.
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 online training covers 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