Adonna Blasko 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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7 Challenges of Managing Change (and How to Deal with Them)

7 Challenges of Managing Change (and How to Deal with Them)

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

Only so much fits into a 40-hour work week. Pressing deadlines, critical projects, and a growing list of priorities can make it difficult to complete everything that needs to get done. Introducing changes adds new layers of complexity to the mix.

But fear not, managing change throughout your organization does not need to be stressful. Having the right processes and tools can help. Let’s take a look at some of the top change management challenges and how to beat them. (more…)

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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What I Learned Through Surviving an Internal Audit

What I Learned Through Surviving an Internal Audit

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

It takes a substantial amount of planning and effort to carry out an internal audit, but the outcomes can improve your processes, the performance of your department, and your outlook. As you’ll soon see, undergoing an internal audit can be a learning experience regardless of your skills or expertise within the organization.

Now, here’s a slight disclaimer: As part of a marketing department, the processes I touch and work through are not directly related to product safety or risk. However, our marketing internal audit was a necessary preparation to drive our entire organization toward our ISO 9001:2008 certification. The tips that follow are not solely relevant to marketing, or to any particular process or department, but reflect a broad overview of what I learned through participating in the audit process. (more…)

Medical Device Complaint Handling: If you can’t stop the complaining, start the efficiency gaining.

Medical Device Complaint Handling: If you can’t stop the complaining, start the efficiency gaining.

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

Complaints can come from anywhere; it’s what you do with them that matters.

And when it comes to reportable events, time is what matters most. The clock begins ticking the moment your organization becomes aware of a complaint. Having an easy-to-use, intuitive medical device complaint handling system can make all the difference when you need to quickly get information to the FDA CDRH or any other regulatory body. Your organization may never be able to fully eliminate complaints, but it can improve their handling.

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8 Sites Life Sciences Quality Managers Should Follow

8 Sites Life Sciences Quality Managers Should Follow

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

When it comes to keeping your ears tuned to the latest industry news, there are so many resources and voices vying for your attention. It can be tough for Quality Managers to know which sources to really keep an eye on, which to bookmark when you need to research or gather information on a particular topic, or where to go for commentary on industry hot buttons. Here we’ve gathered a list of resources you should browse, bookmark, or tune in to help keep you informed. In no particular order, here are 8 resources and one bonus site to peruse. (more…)

5 Quality Management Software Lessons You Can Learn from Superheroes

5 Quality Management Software Lessons You Can Learn from Superheroes

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

Superheroes give us an escape from everyday life and embody qualities to which we’re supposed to aspire. Though fictional, superheroes transport us to another world and can motivate us mere mortals to be more considerate of one another. They also have the power to convince us to open up our wallets for various movies, memorabilia, or miscellaneous merchandise. But at their core, they can also teach us some great life lessons, and even some that correlate directly to quality management. Don’t believe me? Let’s take a look at 5 quality management software lessons sourced from a variety of superheroes. (more…)

Strategies for Electronic Medical Device Reporting (eMDR) Success [free e-book]

Strategies for Electronic Medical Device Reporting (eMDR) Success [free e-book]

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

We’ve all been anticipating the final electronic reporting deadline since last Valentine’s Day when the deadline of August 14, 2015 was first announced. Are you ready? For all medical device manufacturers and importers out there, don’t get stuck with a less than ideal process just to meet this deadline. Get your complimentary e-book to arm your company with knowledge you need to build a successful electronic medical device reporting process that works best for you.

Whether or not you are already submitting your medical device reports electronically, this e-book can help you understand how the process works, and design a great eMDR process to meet your mandatory reporting requirements. Learn tips from companies who were the first to implement, and get a handle on all the steps you will need to follow. (more…)

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…)