Are You Prepared for an FDA Inspection?

If the FDA were to call and schedule an inspection at your facility in two weeks, would you be ready? That’s the critical situation addressed in a recent webinar with Linda Chatwin, regulatory affairs consultant for Underwriters Laboratories’ (UL) Advisory Services group, and Walt Murray, director of MasterControl’s Quality and Compliance Consulting services.

In the webinar, Chatwin and Murray shared their wisdom on the value of proper preparation when an FDA inspection is scheduled. The presentation is the first of a series of monthly MasterControl Customer Webinars. The free webinars will replace the regional user group (RUG) program. The series will broaden the geographic scope of the old RUG discussions and include everyone regardless of location.

“That moment in time is a real opportunity for a reality check – for really determining what your current state is, what you need to do and what you can do in the time you have before the FDA will arrive,” Linda said. “You really want to look at it as an all-hands-on-deck opportunity.”

As soon as you receive the phone call from the FDA, you’ll want to review your “How to Handle an Audit” plan and make sure that all of your audit procedures are in place, according to Linda, who has more than 30 years of experience working with regulated medical products. You’ll want to identify the appropriate teams and make sure team members understand their roles and responsibilities in the inspection. You’ll want to train team members on what they should expect during the inspection and what items they should have ready in their areas. You’ll want to refresh everyone on the quality system requirements and the company’s quality policy.

“The best way to survive an FDA inspection is to always be prepared for it,” Linda said.

Tips to Maintain a Constant State of Readiness

It’s important that your organization has an existing FDA policy and procedure in place, that employees receive ongoing training on the policy and procedures, and that they understand what to expect during an inspection.

An effective tool for helping to maintain a constant state of readiness is a robust, well-organized internal audit program, which should include mock audits. “Conducting mock FDA audits is an excellent way to keep in a state of readiness and help employees in the organization understand what it would be like when the real FDA comes and audits [your organization],” Linda said.

Previous external audits (e.g., customer, supplier, FDA) also offer lessons to aid in audit preparation. “Of course, anybody in the medical device business is having customers coming in and auditing them on a regular basis,” Linda said. “Also, performing supplier audits helps keep in mind some of the ideas that we need to include in our own internal audit program.”

Even if you have an external or mock FDA audit, however, Linda stressed the importance of routine internal audits. Because an audit is a sampling of a process or activity at a point in time, you can’t examine every practice, process and procedure during any given audit. For this reason, it’s crucial to not just conduct internal audits regularly, but to also monitor and review the results to determine if there are recurring problems or new problems in areas that weren’t addressed during previous internal audits.

Walt advised understanding technique regarding the nature of the investigation that may occur. “If it’s the FDA, it’s always going to have a product-risk orientation relative to biocompatibility or exposure of product to dirt, debris or something that may not be aseptic under GMP conditions,” according to Walt, who has more than 32 years’ experience working with highly regulated companies.

“The best way to be prepared is to look at your mock audit or preparation as risk-based preparation, and you should be pretty successful in being prepared to host an investigator,” Walt concluded.
To learn more about how to be prepared for an FDA inspection, watch the free webinar “FDA Just Called! Now What?” above or click here

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