Failing an FDA audit can have many negative consequences. First of all, it can result in negative publicity and tarnish a company’s reputation. Secondly, it can lead to more scrutiny in the future by FDA auditors. And finally, failing an inspection can result in a delay in approval of a new drug which can have a significant negative impact on a company’s image and financial outlook. So if the consequences of a failed inspection are so detrimental, how can companies better prepare for and handle FDA audits so as to limit the probability of a failed audit.
Companies should treat their process of preparation, management and follow up activities related to FDA Audits as a strategic project and give it the same importance as other key regulatory and compliance projects. The regulatory compliance processes are increasingly becoming a source of strategic advantage for Pharmaceutical companies and consequently, the projects and activities driven by regulatory compliance demand a more strategic lens through which to lead, plan and manage.
The following keys to success for any strategic initiative can be applied to the process of preparing for and managing an FDA Audit.
- Establish clear sponsorship and governance – ensure that there is an executive sponsor providing overall leadership for the FDA Audit and providing key communication to the company and to the FDA. Also ensure there is a cross functional governance team providing overall oversight and making key decisions as needed during and after the audit.
- Establish a project team with clear roles and responsibilities – the project team should be led by an experienced project manager and all members of the team should have clear roles and responsibilities. One critical role to identify is that of the “FDA escort” who will be accountable for accompanying the FDA auditor at all times and meeting their needs and requests.
- Define clear goals, objectives and outcome measures – the goals, objectives, and outcome measures for the audit should be agreed upon between the company and the FDA auditor and communicated to all team members.
- Develop an overall program plan and establish key work streams and work stream owners – the FDA audit may have many different activities and areas of focus that the FDA is auditing. It is critical that the audit be broken down into key components and work streams and that each work stream has a clear project plan and owners. Each work stream’s activities should be tracked daily and the work stream owners should report on progress at the end of each day of the audit including the tracking of issues, risks, and mitigation plans.
- Effective communication – communicating to the company, project team, and FDA effectively in preparing for and managing an FDA audit is important to ensure success. Key communications include; a) communicating to the company that an FDA Audit is about to happen or is happening, b) communicating answers to audit questions and findings to company management and the FDA , c) communicating status and progress to key stakeholders and d) communicating the final FDA audit outcome to the company and if needed to external stakeholders. Having a communication specialist develop the communication plan and coach key team members in throughout can be very helpful
The ultimate benefit of applying strategic project management principles and rigor to an FDA Audit is of course to not have any adverse findings during the FDA audit and “passing” the audit. Additionally benefits include improved readiness and awareness across the company, more organized managing of information and documents, more effective risk and issue management, more effective solutions, and improved communications and relationships with the FDA.
John Cassimatis | Co-founder & President | TayganPoint Consulting Group | email@example.com
Amy Flynn | Managing Director | TayganPoint Consulting Group | firstname.lastname@example.org