Archive for the ‘QSN News’ Category

Tips for Hiring Specialty Expertise Consultants

Outsourcing with Confidence: A Guide to Successfully Hiring Specialty Expertise Consultants in Healthcare

Outsourcing, partnering, or hiring specialty expertise consultants—regardless of the term used, this practice is becoming increasingly prevalent in the healthcare industry. Faced with budget cuts, downsizing, and layoffs, manufacturers of drugs, medical devices, biologics, and combination products are turning to external consultants with specialized expertise and a deep understanding of ever-changing quality regulations. This approach allows these companies to supplement their internal teams cost-effectively. Read more »

Your Guide to the 2024 Combination Products Summit: Agenda, Insights, and What to Anticipate

Agenda and Expectations for the 2024 Combination Products Summit: Navigating the Future of Healthcare

The healthcare landscape is constantly evolving, and with it, the need for innovative solutions in combination products—those unique blends of drugs, devices, and biologics that present distinct challenges for development and commercialization. The 2024 Combination Products Summit is the premier event where industry leaders, regulators, and experts come together to tackle these challenges head-on.

This year’s summit promises to be more impactful than ever, offering a comprehensive agenda that will equip professionals with the knowledge and tools they need to navigate the complexities of combination products in a dynamic regulatory environment.

Read more »

ComplyFDA Presents: Baseline Assessment

Enhancing Quality Processes: ComplyFDA’s Insightful Approach to Baseline Assessments

Recently, Michael Kuehne at ComplyFDA conducted a deep dive into developing a baseline assessment using a risk-based approach looking at all quality processes. This approach delivers actionable improvement recommendations and incorporates validated best practices to ensure robust solutions. I found this analysis extremely insightful and wanted to share it with you: Read more »

Quality Solutions Now Turns 20!

Celebrating 20 Years of Excellence and Innovation!

Twenty years ago, Quality Solutions Now (QSN) embarked on a mission to create a world where health is protected and promoted through the manufacturing of safe and effective medical products. From our humble beginnings in October 2004, QSN has seen tremendous growth, now serving a diverse range of clients in the medical device, drug, and biologic manufacturing sectors.

As we celebrate our 20th anniversary, we reflect on our journey and the remarkable milestones we’ve achieved. Here’s a look at our progress:  Read more »

Announcing QSN and ComplyFDA Partnership!

Quality Solutions Now and ComplyFDA Partnership

Leading the Way in Life Sciences Compliance and Quality Management

Quality Solutions Now (QSN) and ComplyFDA have joined forces to offer unparalleled solutions in quality management and regulatory compliance for the life sciences industry. This collaboration enhances our capabilities in providing comprehensive, scalable, and cost-effective solutions, ensuring clients meet and exceed quality and regulatory standards. Read more »

If you fail to plan, plan to fail

We’ve all heard this saying, right? Sometimes though, it takes a fail in our lives for us to remember it again and let it sink in!

This time of year many of us are getting in some much needed travel time, hoping for some rejuvenation and fresh outlooks for ourselves and our careers. This past month, I did just that! My family and I traveled to Europe for a 3 week adventure! I was in full planning mode by arranging all the details and planning what we would see in all the places that we traveled to. This wasn’t necessarily a relaxing vacation (when in Europe, you need to see all you can to justify the 24 hour door-to-door travel time), but since planning comes naturally to me as a project manager, I thought I would nail this planning process as “tour director” for our vacation.

Boy was I wrong! Read more »

A changing perspective

Perspective…we all have one, but have you ever had an experience that made you change your perspective? I recently had one of those moments at the 2017 Parenteral Drug Association (PDA) Annual Meeting I attended in May. Read more »

How to comply with 21 CFR Part 4

The 21 CFR Part 4 final rule may seem like old news, but most of the combination products industry is still unclear what to focus on in order to be in compliance with the final ruling. Since the regulation went into effect in July, 2013, every combination products manufacturer is at risk to an audit. Here’s a quick guide to get you on the right path to full compliance before the auditors knock on your doors. Read more »

10 Years, Many Milestones and an Excitement for What’s Ahead

Ten years ago Quality Solutions Now (QSN) was founded with the vision of helping to create a world where companies protect and promote health by manufacturing safe and effective products that deliver cures, treatments, or preventions of diseases, or other medical conditions. Since that simple beginning in 2004, QSN has grown to now serve many medical device, drug and biologic manufacturing clients throughout the United States and internationally. Read more »

QSN Q3 Update – New Logo and More!

Can you believe it is officially fall? They say time flies when you’re having fun and that has proven to be the case here at QSN. Last time we connected I mentioned we were almost at the finish line with the development of our new logo and we were getting ready to begin work on our new website. I am happy to report that we finally crossed one of these big items off our “to do” list! Here’s a quick update on that and some other exciting news at QSN. Read more »