FDA Inspection Readiness

We can come into your office and work with your employees to prepare for the best possible outcome. Our clients for FDA inspection readiness audits include:

• Clinical Investigators
• Sponsors
• Manufacturers

Benefits:

• Mock inspections provide an opportunity to coach employees during interviews
• Fine tune logistical plans
• Ensure records are readily available
• Refresh key individuals on the project
• Identify any issues which might have been missed
• Ensure the best possible outcome by being prepared and practicing communication skills

Common Discoveries:

• During the mock interviews, it was obvious that some employees were nervous and struggling with communicating with the regulatory authorities. Through the mock interview process, the best employees for presenting information were identified.
• One company faced several challenges during the course of their project. During the mock interviews, difficult questions were asked. Brainstorming sessions were held to re-enforce the ethical requirement to be honest in all responses, but to also use this opportunity to focus on recent process improvements.