Mastering FDA and Regulatory Affairs Inspections

In our ongoing blog series on regulatory affairs inspections, we have emphasized the importance of making a positive first impression when inspectors or investigators arrive and how to effectively prepare for their visit. We have covered key steps like forming a preparedness inspection management team and exploring basic and advanced options for inspection management software to help streamline the inspection process. In our previous post, we also discussed the critical personnel to have available during an inspection.

Now, in this latest installment, we are diving deeper into the important aspect—how to fulfil the inspector or investigator’s requests during the inspection day.

Inspection Day: Setting the Stage for Success

When inspection day arrives, it is time to ensure everything runs smoothly. Here is what you need to have in place:

• Audit Room Setup: Create a dedicated space for the inspector to do their work—this is known as the audit room.

• Inspector Team: The inspector will be accompanied by a host and at least one scribe. The scribe’s role is crucial as they document everything the inspector says, ensuring clear communication between the inspector and your backroom team.

• Backroom Support: The backroom is your command center and can consist of as many personnel as needed to help fulfill requests and keep the process moving smoothly. The goal is to fulfill any inspector’s request within 15 minutes or less.

Fulfilling Inspector Requests: Paper, Electronic, and Interviews

When it comes to fulfilling an inspector’s requests, efficiency is key. There are three primary types of requests you will need to address: paper records, electronic records, and interview requests.

1. Paper Requests: Handle with Precision

Paper records are straightforward, but must be managed carefully:

• Check Completeness: Ensure that the requested paper document is complete and that there are no yellow stickers or other marks that could suggest missing or redacted information.

• Identify the Right Person: Determine who is best suited to speak to the document’s details and direct them to the inspector if needed.

• Provide the Document: Once the appropriate person is identified, hand over the document to the inspector. Once they are done, they will return it.

1. Electronic Requests: Streamlining the Process

For electronic records, the process is much simpler and faster, especially when you have the right inspection management software in place:

• Review the Record: Quickly check the electronic document in the backroom.

• Send to the Investigator: Once reviewed, send the requested electronic record directly to the inspector, minimizing the time spent handling the request.

1. Interview Requests: Preparing Your Subject Matter Experts (SMEs)

If the inspector or investigator requests to interview someone from your team, ensure you have the right Subject Matter Expert (SME) available. For example, the investigator may want to speak with someone from quality control or microbiology.

• Interview Etiquette: The SME must be prepared for questioning in a formal manner, similar to testifying in a courtroom:

• Listen Carefully: The SME should carefully listen to each question. If a question has two parts, ask for clarification, “Which question would you like me to answer?”

• Keep Responses Concise: Responses should be brief and to the point. Avoid elaborating or going off-topic. Only answer “yes” or “no” unless further explanation is necessary.

• Maintain Composure: After answering, the SME should immediately stop speaking and wait for the next question, maintaining calm and professionalism throughout the process.

Proactive Preparation: Practice Makes Perfect

The key to success during an inspection is practice. The more you prepare, the smoother the inspection will go:

• Mock Inspections: Conduct practice inspections and simulate document retrieval and presentations. This will help everyone feel more confident and ready for the real thing.

• Virtual Presentations: Practice showing documents digitally to ensure the process is fast and efficient.

• SME Drills: Grill your SMEs with mock questions, offering feedback and guidance so they are ready to handle any inquiries during the inspection.

Why Choose BioBoston Consulting for Inspection Preparation?

At BioBoston Consulting, we specialize in helping companies prepare for inspections, ensuring compliance, and handling regulatory affairs with precision. With years of experience in the field, our team of former FDA inspectors and industry experts will guide you through the inspection process, helping you to meet the demands of even the most rigorous audits.

Our services include:

• Inspection Management Consulting: Helping you form a robust preparedness team and utilize the right inspection management software.

• SME Training: Preparing your Subject Matter Experts for interviews with regulatory authorities.

• Inspection Practice Sessions: Running mock inspections to ensure your team is fully prepared.

Ready to Ace Your Next Inspection?

If you want to make sure your organization is inspection-ready, contact BioBoston Consulting today. Our experts will provide tailored solutions to ensure that your inspection process runs smoothly, and that you are able to fulfill every inspector's request efficiently and on time.

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