Remote FDA Audit Participation

[That Guy]

I am preparing for an upcoming on-site FDA audit at my company. One of our technical leaders, who will be a key participant and SME, lives abroad. It would be ideal if she could call in and participate remotely. Is this generally accepted in an FDA on-site audit? Do I need to ask the auditor what to do? Are there any considerations we should make for this to be a success, or does she really need to fly over and be here on site?

 

[yodon]

Shouldn't be a problem, I wouldn't think, unless the time differences start causing delays. Presume all your records of compliance will be local.

Might not hurt to let the inspector know that you do have one person offsite but can participate via video call (or whatever). Make sure she understands that she should be available at all times during the inspection.

You might want to see where in the inspection she would participate, anticipate requests for those documents / records, and have them queued up in case they are requested. That might help minimize the coordination time between you and her during the audit.

 

[Parul Chansoria]

@That Guy first of all - best wishes for the upcoming FDA inspection.

About your question - I have participated and led many inspections and audits in the capacity of a Regulatory and Quality VP/Director for medical device and IVD companies and never has there been an issue. Hence, I would suggest that a key participant can definitely contribute remotely. Certainly, the regulatory bodies are more accepting of this now than before.

However, it is very important that the preparation is thorough and the following things are thought of:

• Virtual Connection Reliability:
  • Ensure a secure and stable connection for real-time interaction.
  • Guarantee effective document sharing during the inspection.
• Communication Channels:
  • Establish clear and reliable communication channels for seamless interaction.
  • Do a prelim check of the remote team member's set up for effective engagement.
• Documentation Accessibility:
  • Organize files systematically for quick and efficient access. I recommend having internal chat groups and logically thinking about the participants.
  • Ensure the remote team member can promptly address inspector questions with readily available documentation. Questions can also be parked sometimes and reply can be give a little later in case something needs to be checked before answering.
• Technical Glitch Preparedness:
  • Develop a contingency plan for potential technical issues during the remote inspection.
  • Provide support for alternative communication methods to mitigate disruptions. You can also have some back up personnel who may be able to engage if there is a technical glitch.
• Familiarity with FDA Inspection Process:
  • Ensure the remote team member is well-versed in the specifics of the FDA inspection process. If the person is not from a regulatory/quality background then a small training by RAQA can help.
  • Provide training on navigating virtual platforms and presenting information comprehensively. You may want to do a mock.

By taking these comprehensive steps you can ensure that the company is adequately equipped. Of course, these could be further simplified depending on your company size etc., but I would definitely recommend thinking through these and ensuring you are all set.

Best,
Parul Chansoria
MS, RAC, CQA
Regulatory and Quality Expert