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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Fusion 2016: Reflections of a First-Timer

Fusion 2016: Reflections of a First-Timer

Rick Lowrey, CEO, Pilgrim Quality Solutions

“The most successful customer conferences are contingent on active customer participation and Pilgrim team collaboration.”

#PilgrimFusion 2016 was my first customer event since joining Pilgrim Quality Solutions as CEO in May 2015.  I had the opportunity to meet many customers at once and learn and understand their experience with Pilgrim as their compliance and quality partner. Having spent years in software, I’ve attended my share of user conferences both as a user and as an employee of an enterprise software business, but this year was an entirely new experience. (more…)

How Change Management and Continuous Improvement Work Together

How Change Management and Continuous Improvement Work Together

Massimo Franza, Senior Director of Software Development, Pilgrim Quality Solutions

As my colleague Kevin Lee says in his blog, The Pursuit of Zero Waste: Continuous Improvement to Drive Quality:

The Pursuit of Zero Waste requires that an organization continuously improves its current products, processes, and people involved in making the perfect device, the perfect item or the perfect process to yield zero waste.

So he really talks about how continuous improvement is the key to remain successful and to keep your organization growing.

In today’s post, we’ll discuss the relationship between change management and continuous improvement. (more…)

3 Considerations for QMS Rapid Implementation: Like Sands through the Hourglass

3 Considerations for QMS Rapid Implementation: Like Sands through the Hourglass

Sandy Carson, Marketing Communications & Events Manager, Pilgrim Quality Solutions

Time waits for no one. No one is more aware of this than companies that cater to the world’s growing health care industry. These organizations walk a fine line every day between producing life-altering solutions as quickly as they can conceive of them, and doing so in full regulatory compliance and to 100-percent quality.

Life Sciences companies today are performing this balancing act between productivity and quality amid myriad growing pressures from customers, suppliers, and regulators, as their operations are having increasingly global impact. When you sprinkle risk management concerns and reputation management into the operations mix, the pressure grows even stronger. (more…)

Top Concerns for Quality Audits: 5 Highlights from Last Week’s SmartSolve Audit Management Webinar

Top Concerns for Quality Audits: 5 Highlights from Last Week’s SmartSolve Audit Management Webinar

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

Recently, we hosted two live demonstrations of SmartSolve Audit Management. The webinar covered a number of topics including how to perform mobile audits, creating audit programs and schedules, working on audits, and managing audit followup.  The webinar also included live Q&A during both sessions.

Some key themes emerged during both sessions that helped us understand the challenges you may encounter when carrying out quality audits, and how SmartSolve Audit Management can help.

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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…)

The Pursuit of Zero Waste: Continuous Improvement to Drive Quality

The Pursuit of Zero Waste: Continuous Improvement to Drive Quality

Kevin Lee, Industry Solutions Consultant, Pilgrim Quality Solutions

Quality Challenges Create Waste

In a perfect world, all products are designed and manufactured to 100% of their design specifications; all people are trained and certified; and, all equipment is properly maintained and calibrated. All incoming supplies are used in the manufacturing processes, and there are zero deviations or defects. This nirvana product paradise does not exist in our world. (more…)

Get Your Documents Under Control

Get Your Documents Under Control

Sandy Carson, Marketing Communications Manager, Pilgrim Quality Solutions

Do people ever tell you that you’re a control freak? That’s not typically a compliment, unless you work in the Quality or Compliance departments at your company. Then it’s an aspiration.

A robust Document Control process lies at the heart of a Quality Management system. Nearly every element of auditing and compliance is verified by examining documented evidence. That’s the FDA inspectors’ bread and butter, so to stay compliant, you need to keep your organization’s documents fresh and handy. (more…)

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…)

Building a Long Term Quality Management Analytics Strategy

Building a Long Term Quality Management Analytics Strategy

Dan Jacob, Research Analyst, LNS Research

Manufacturers have historically struggled to generate meaningful Quality Management Analytics. With the advent of the Industrial Internet of Things (IIoT) and Big Data Analytics, it’s now more important than ever to have a long term Quality Management Analytics strategy. (more…)