Investing in a Regulatory Mock Inspection (Mock) exercise is a trending industry audit readiness approach. Many sponsors and CROs are conducting Mocks to determine organizational inspection and audit readiness; however, key outcomes are not generally shared within the industry. This represents a lost opportunity on multiple levels considering that – according to data from the Office of Scientific Investigations (OSI, CDER) – The US Food & Drug Administration (FDA) conducted close to 8,000 inspections in total and inspected almost 4,000 clinical investigators between FY 2005 and 2014. In the same period, a total of 515 inspections were performed at sponsors, sponsor-investigators and Contract Research Organizations (CROs). Given these numbers, it is critical that your organization take preventative steps to mitigate risks.
More open sharing of observations and lessons learned from Mocks can provide valuable insight on how to ensure the best return on investment for companies choosing this valuable inspection readiness approach. Industry sharing can ultimately lead to other benefits, including but not limited to, more rapid professional development and process improvements across companies.
Both Quality Assurance Professionals and R&D Subject Matter Experts (SMEs) can benefit from understanding common Mock outcomes, including those related to planning, processes, documentation, and behaviors. Don’t waste time and money by making easily avoidable mistakes. Execution of a Mock based on lessons learned from industry will ensure that your inspection readiness exercise accurately identifies gaps that are truly specific to your organization, providing the most bang for your buck.
At the completion of this session, you will be able to:
- Plan, facilitate, and/or participate in the best possible regulatory mock inspection by having a better understanding of the focus, roles, and goals, all while avoiding common mistakes
- Identify the best potential employees for each key inspection role, ensuring that they fully prepared for the Mock
- Understand and avoid common industry mistakes to pave the way for better identification and focus on more company-specific gaps
- Get the best possible return on your Mock investment