FDA Posts

FDA Warning Letters, 483s, and Funnel Clouds: What do tornadoes have in common with FDA inspections?

FDA Warning Letters, 483s, and Funnel Clouds: What do tornadoes have in common with FDA inspections?

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

What do inclement weather and FDA inspection results have in common? Whether you want to believe it or not, they can both escalate from serious to disastrous fairly quickly. For anyone who’s spent significant time in the Midwest or tornado alley, it’s common knowledge that a tornado warning is more serious than a tornado watch. The truth is, the tornado alert system has quite a bit in common with FDA inspections, FDA Warning letters, and FDA form 483s. Let’s take a closer look.

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Resources for FDA Compliant Change Management

Resources for FDA Compliant Change Management

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

Like the corrective action process, the change management process is a central part of your quality management system. Change is difficult to manage because it touches every area of your business (including suppliers) because it is constant, and because the process to manage it needs to be compliance-driven. If you already have a change management process in place, here are some resources to help you understand areas where your process can be more harmonized, compliant, and efficient.

Tell the whole story about each change.

This Q&A on FDA compliant change management provides insight into better managing impact assessment and documentation of a change. These areas are typically weak in most change management processes. The article points out that change documentation is often weak or incomplete because there is an internal assumption that “everyone knows what is going on.” When an auditor or other third party later reviews the change, the record seems incomplete because it doesn’t tell the full story. This can make the process seem less thorough or compliant than it actually is.
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Get a Grip on your Data Integrity

Get a Grip on your Data Integrity

Christoph Knez, Sr. Account Executive, Pilgrim EMEA

Data Integrity is one of today’s hot topics in the Life Sciences industry. Look at the agenda of just about any industry conference, summit, or workshop event over the last two years, and you’ll notice Data Integrity has found its way into nearly every one.

If you listen carefully to attendees and others in the industry who are responsible every day for ensuring data integrity, you’ll hear how this very complex requirement creates a lot of anxiety among many companies when they examine their particular quality management processes. Their main objective is to avoid any observations by regulatory bodies resulting from data integrity issues. But why is it so complex?

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3 QMS Considerations for Combination Products

3 QMS Considerations for Combination Products

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

Combination products bridge medical devices, pharmaceuticals, and biotech products. Each of these areas has its own respective pre and post-market regulatory requirements, making combination products all the more complex to juggle while adhering to FDA requirements and guidance. (21 CFR parts 3 and 4, 210/211, 820, and 606)

I recently attended a session presented by Frank Davis, Regulatory Director, Pharmaceuticals with RCA Associates where he covered this topic extensively for a group of SmartSolve LifeScience EQMS users and Pilgrim employees. The ideas presented below are snippets from his session.

When it comes to how to position your combination product to the FDA when seeking market approval, many things to consider are common sense. Here are 3 key QMS considerations for combination products.

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How to Prepare for Your Next FDA Inspection (Free E-Book)

How to Prepare for Your Next FDA Inspection (Free E-Book)

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

Think about your next FDA inspection. How will you feel when the inspection arrives at your facility? Will you be rushed or calm? Flustered or confident? Perhaps more importantly, who will control the direction of the inspection? You… or the inspector? (more…)

Prepare To Succeed: Stay Ready For Your Next FDA Audit

Prepare To Succeed: Stay Ready For Your Next FDA Audit

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

Congratulations! You’re being audited by the FDA! If you’re doing business within the United States, you may find your organization faced with an unannounced FDA audit. But unannounced doesn’t mean that you need to be unprepared or out of control. Let’s take a closer look at ways you can prepare yourself, your team, your site, your quality system, and even the FDA inspector for a successful audit.

“An audit is a unique opportunity for you to tell your story. In
essence, you are communicating and demonstrating how
you run your business within the framework of your Quality
Management System.”

Konyika Nealy, VP of QA & Validation, Pilgrim Quality Solutions

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4 Nuances to Nothing in eMDR Electronic MedWatch Reports (A Riddle)

4 Nuances to Nothing in eMDR Electronic MedWatch Reports (A Riddle)

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

Riddle me this: Why is an eMDR not a true electronic equivalent of a Form FDA 3500A MedWatch report?

Do you know the answer? If you don’t — that is, if you didn’t respond, or your mind went blank on this riddle — well, then you’d technically be correct. If this still isn’t making sense, you’ll understand by the end.

You see, aside from the obvious answer that one is a fillable PDF form and the other is an electronic XML file, there also are distinctions regarding the acceptable manner for leaving fields blank when you have “nothing” to answer. (more…)

Electronic MedWatch Reporting: eMDR Testing with CDRH (Free E-Book)

Electronic MedWatch Reporting: eMDR Testing with CDRH (Free E-Book)

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

A few months back, we hosted a webinar on the eMDR Countdown to Compliance during which we learned that from beginning to end, the transition to electronic medical device report submissions (electronic MedWatch or FDA Form 3500A reporting) can take between four to six months. But how do you really know that you’re ready to comply with the new mandate?

Today, let’s point the microscope at one piece of the puzzle: testing your electronic medical device report submissions with the FDA’s CDRH. Testing gives you the opportunity to identify and correct trouble areas before you transition to production electronic reporting. (more…)

Medical Device Single-Audit Pilot: Will it Fly?

Medical Device Single-Audit Pilot: Will it Fly?

Sandy Carson Hessen, Marketing Communications Manager, Pilgrim Quality Solutions

We’ve all seen them. Some flop, some fly. Television Pilots — stand-alone episodes of television series used to sell shows to the networks by gauging whether a series will be successful. After seeing this sample of the proposed program, networks then determine whether the expense of additional episodes is justified.

There’s another type of pilot airing right now in the Medical Device industry, and the purpose is similar. (more…)

Go to the Head of the Class: 3 Ways Employee Training Puts Quality Front & Center

Go to the Head of the Class: 3 Ways Employee Training Puts Quality Front & Center

Sandy Carson-Hessen, Marketing Communications Manager, Pilgrim Quality Solutions

There’s a popular saying: ‘You don’t know what you don’t know.’ No kidding. But nowhere is this truer than in the regulated workplace. When employees aren’t trained, they run the risk of adversely impacting its quality, its compliance, its reputation, even its profits.

That’s why employee training is an essential component of a comprehensive quality management system. In fact, you’re likely to find well-trained employees at the foundation of any successful organization that manufactures safe, dependable, quality products. (more…)