At The FDA Group, we understand the importance of being fully prepared for an FDA inspection. Our Mock FDA inspection services simulate a real FDA inspection and often go well beyond simple compliance assuredness to help your firm anticipate potential inspection scenarios, identify gaps, plan remediation steps, train staff, and cover every other dimension of inspection readiness.
Our in-depth guide covers the basics of mock FDA inspections, the reasons to conduct one, and exclusive best practices and recommendations from our team.
Pre-approval Inspection (PAI) Mock Inspections
These mock inspections/audits help you prepare for a PAI by the FDA, ensuring your readiness for new product approval or significant changes to an existing product.
GMP Compliance Mock Inspections
These audits assess your adherence to Good Manufacturing Practices (GMP) as the FDA requires. They cover various aspects of manufacturing, including cleanliness, validation of equipment and processes, and documentation of procedures.
GLP Compliance Mock Inspections
These inspections evaluate adherence to Good Laboratory Practices (GLP) regulations. They help determine if your data collection, recording, and storage practices meet FDA standards.
GCP Compliance Mock Inspections
These inspections assess your compliance with Good Clinical Practices (GCP), which are required for clinical trials. They evaluate patient informed consent and safety and ensure that patients understand the trials.
For-cause Mock FDA Inspections
These mock inspections are conducted when there's a suspicion of non-compliance or in response to a specific issue that has been identified following an enforcement action. They help you address and rectify the problem quickly, preventing a small issue from turning into a larger, systemic issue.
Watch our Q&A with one of our experienced former FDA consultants, where we address some of the most frequently asked questions about the FDA's PAI program and how to prepare accordingly.
Learn how The FDA Group partnered with a large healthcare product Company to support a Pre-Approval Inspection (PAI) audit preparation project and subsequent quality system remediation efforts at a site within the European Union.
At The FDA Group, we pride ourselves on our deep bench of auditors, many of whom are former FDA professionals. Their intimate knowledge of the FDA inspection process and regulations provides invaluable insights and mimics the style of actual FDA investigators.
Our consultants simulate an actual FDA inspection at your site or facility, conducting a sort of inspection pressure test and rehearsal combined with a training component to close gaps and enhance every element of readiness. In some cases, these internal mock audits can even be more stringent than actual regulatory inspections, going far deeper into the quality system and sometimes sparking large-scale remediation projects.
Whether you're preparing for an internal mock inspection to evaluate your own facility or need to conduct an external mock FDA inspection of a supplier or vendor, our team of experienced consultants is ready to help.
Is your team using Veeva as your eQMS? In addition to conducting audits, we can complete your data entry directly within your Veeva system, saving you significant time and attention.
Our dedicated project support team works directly with our auditors to streamline the process of inputting audit reports into the Veeva platform. We’ll guide your Veeva Administrator through the steps to confer the necessary user permissions in the platform and take care of the audit input on your behalf.
Contact us to learn more about integrating Veeva management into your auditing service so you can focus on your core operations.
Our resources can be utilized to meet the wide range of auditing requirements throughout the life sciences, as well as to support staffing assignments, lead and manage related activities, bridge staffing gaps, and provide long-term or interim leadership.
Please contact us to learn more about our auditing services. We help clients secure a wide variety of life science resources for both contracted and direct hire engagements with the perfect combination of qualifications, experience, and motivation for succeeding in challenging and demanding projects.