This one-of-a-kind DVD training tool features a unique insider perspective as Mr. And points out red flags that alert you when an inspector is sniffing for a specific problem. Viewers can clearly identify the key learning points as they are highlighted on screen and elaborated by Tim through his fine-tuned examples, interactive exercises, group discussion and a final exam. In just tightly focused minutes, you and your staff will discover best practices for passing FDA device inspections.
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But what if you're past that point in the process? What if you get a knock on your door and it's a surprise visit from an inspector?
As you're probably well aware, the medical device industry is packed with confusing terms and cryptic regulations. Inspectors are required by law to show their credentials upon conduction of an inspection.
Your records are your proof. They should demonstrate that you are following your written procedures, supported by all ongoing activities. If you are having a full routine inspection, you can expect that a Level 2 Baseline QSIT will be conducted, which is a comprehensive review of all four main subsystems. This is often structured to take around four days, often with one subsystem inspected per day. Inspectors will prepare ahead of time to visit your particular facility.
If you have been inspected previously, an inspector will use that information to prepare for the next one. For example, they may look at:. This will prove to be very beneficial for reference later on in the process or at a future date. You should also expect that every inspector is different. I often refer to the fact that FDA inspectors are only human, just like the rest of us. You can expect different levels of experience, different personalities and different interests among inspectors.
For example, one may pay much closer attention to a certain area than another - this often comes down to their own experience and personal preference.
During this closing meeting, the inspector may share their findings and indicate what may or may not result in the issuance of FDA Form - an official list of findings that the company needs to address. If there are any observations, the inspector will usually give the company the opportunity to discuss them and make any clarifications to defend their position.
You can agree to correct those findings as part of your response to the official report. You have 15 calendar days from receipt of Form to send a response to FDA. Following the quality system inspection of your medical device company, the inspector will write up an official Establishment Inspection Report and communicate all findings with their district. You can usually obtain an official copy of the report within 60 days. One of my preferences is to always look for the proactive steps you can take toward continuous improvement.
As medical device manufacturers, you can expect to be inspected. Preparing for an inspection has never been easier--you might even look forward to your next one. Join us virtually June 2nd-4th.
See the Demo. Subscribe See the Demo. Search Results for:. Some regulations may not be relevant to you, for example, Class I devices do not require design controls. It is up to your company to determine what is applicable to you, perhaps with the assistance of a regulatory consultant. To interview key personnel within your organization. To review the records that back up your processes. They may wish to take a sampling with them as it is not possible for them to review absolutely everything in one sitting.
For example, they may look at: Previous reports. Previous observations or warning letters. Previous responses to observations or warning letters. Any consumer complaints or recalls that have occurred since the last inspection. After the QSIT inspection Following the quality system inspection of your medical device company, the inspector will write up an official Establishment Inspection Report and communicate all findings with their district. Almost there! Please complete this form and click the button below to gain instant access.
Related Articles. Read More. Want more free medical device resources? Get in-depth weekly articles, right in your inbox. Jon knows the best medical device companies in the world use quality as an accelerator. That's why he created Greenlight Guru to help companies move beyond compliance to True Quality. Back to blog listing page. Third party trademarks, logos and trade names appearing on the site are the property of their respective owners.
The FDA QSIT: Understanding What Happens During a Medical Device QMS Inspection
But what if you're past that point in the process? What if you get a knock on your door and it's a surprise visit from an inspector? As you're probably well aware, the medical device industry is packed with confusing terms and cryptic regulations. Inspectors are required by law to show their credentials upon conduction of an inspection.
Secrets of QSIT-Based Medical Device Inspection Preparation
FDA Guide to Inspections of Quality Systems