Compliance Posts

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?
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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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Document Management in the Quality Fold: What You Should Know

Document Management in the Quality Fold: What You Should Know

Sandy Carson Hessen, Marketing Communications Manager, Pilgrim Quality Solutions

If you work in the Quality arena, you probably know that the effectiveness of a Quality Management System (QMS) relies extensively upon enterprise-wide collaboration and begins with a solid process for managing important documents, like standard operating procedures. But as rapidly as business and its processes evolve these days, many organizations struggle to stay current in a sea of change. So it’s not surprising that document management remains at the very top of quality management processes being automated within the highly regulated Life Sciences space. (more…)

Leverage Your CAPA Process to Build a Culture of Quality (Free E-Book)

Leverage Your CAPA Process to Build a Culture of Quality (Free E-Book)

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

The Corrective and Preventive Action (CAPA) process is at the heart of your quality and compliance system. When properly implemented, CAPA resolves and prevents critical problems and also keeps you in compliance with FDA regulations. But year after year, lack of CAPA procedures and documentation make the list of top FDA 483 observations. The FDA closely monitors the CAPA process, which is why you need to have a handle on it as well. (more…)

UDI Resolutions: Ringing in the New Year with Compliance

UDI Resolutions: Ringing in the New Year with Compliance

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

Every year when January rolls around, there’s a cultural shift toward new beginnings and starting the year off right. Countless articles are published about making New Year’s resolutions, and gyms are packed with athletic hopefuls. People resolve to make self-improvements, even in their daily work lives.

A new year can signify the beginning of new projects or initiatives in the workplace, too. This typically includes setting goals to be more effective, efficient and productive than the prior year. (more…)

3 Ideas for Reducing Quality Risks

3 Ideas for Reducing Quality Risks

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

Sometimes small changes make a big difference. You’re already doing the difficult work of managing your quality system to stay in compliance and keep product quality high. But there may be some areas where you can focus to further reduce quality risk. Here are 3 areas to examine if you’d like to make some quick gains toward risk reduction and continuous improvement. (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…)

How to Gauge Your Quality Management Technology Maturity

How to Gauge Your Quality Management Technology Maturity

Matthew Littlefield, President and Principal Analyst, LNS Research

With pressures to drive down costs while improving innovation and the safety of products, life sciences companies need close integration between risk, quality management, and compliance. Conventionally, this connection has been facilitated by a number of homegrown and manual solutions. However, with the unprecedented complexities associated with the industry today, most organizations require something more robust. (more…)

Clinical Trials Guidance: Q&A with Patrick Stone

Mark Crawford

Patrick Stone is president and lead consultant for TradeStone QA LLC in Austin, Texas (www.tradestoneqa.com). A strong advocate for human subject protection, his specialties include bioresearch monitoring in human clinical and pre-clinical trials. The following interview focuses on the FDA and clinical trials. (more…)

FDA Seeks to Standardize Electronic Data Submittals

Mark Crawford

In February the FDA released a guidance document proposing a standardized format for submitting clinical and nonclinical data to the agency. The FDA maintains that by following this protocol early in the product development cycle medical device and pharmaceutical companies can reduce bottlenecks and speed up the approval process. (more…)