Preparing for Remote and On-Site Inspections and Audits

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How can medical device companies be better prepared for remote and on-site inspections or audits? Practice, practice, practice so that you’re always audit-ready.

In this episode of the Global Medical Device Podcast, Jon Speer talks to Steven Niedelman and Eric Henry, lead consultant and senior advisor for Quality Systems and Compliance, respectively, within the FDA and Life Sciences division of their law firm, King & Spalding LLC.

Listen to this episode where Steven and Eric share their keen insights and knowledge from working in the global regulatory sector of the medical device industry and offer best practices and tips that will help you prepare for FDA inspections and other audit events.

Some highlights of this episode include:

• The FDA plans to resume remote inspections by focusing first on mission-critical inspections related to pandemic breakthrough products to play catch-up using a prioritized, risk-based approach.
• Preparing for FDA inspections versus the Medical Device Single Audit Program (MDSAP) and other audits will differ based on type, such as for-cause and premarket inspections or warning letter re-inspections in the United States or European Union.  
• The QMS exemption was created to allow non-traditional device manufacturers to manufacture devices. These manufacturers must comply with 21 CFR Part 820 if they intend to keep their device in the US post-pandemic.
• If you are new to the industry or have a QMS exemption that requires you to do significant remediation of your existing quality system for compliance with FDA QSR or ISO 13485:2016, follow these four steps:
• Scope what QMS elements are needed. 
• Conduct gap assessment.
• Prioritize resolution of gaps to address compliance, safety, efficacy issues.
• Execute comprehensive program plan and continue to update progress.
• Medical device organizations preparing for an upcoming inspection should follow these best practices: 
• Profile investigator.
• Prepare opening presentations.
• Stage accurate and up-to-date SOPs and records.
• Staff appropriately for right roles and skill sets.
• Have a front and back room.
• Conduct dry runs and mock audit/inspection activities.

Memorable quotes by Steven Niedelman & Eric Henry:

“It’s been quite some time since many firms have undergone some inspections and we felt it would be a good reminder for folks to get their house in shape once inspections resume.” Steven Niedelman

“You’ll need to provide more emphasis and more preparation and more drills for your technical and your clinical subject matter experts that are related to the design, the development, the clinical testing, the manufacturer of that particular product.” Eric Henry

“You really need to make sure that you’ve looked at issues systemically, and not just in isolated examples. Again, it’s all about making sure you have evidence to demonstrate that it’s been effective.” Steven Niedelman

“What does perfect look like within a quality system?” Eric Henry

“Keep things going so that you can answer the FDA’s questions in the most expert way possible and in the most expeditious way possible.” Eric Henry