Sizing Up Staff Competency Article

Training employees to perform tasks in a laboratory or technical environment is critical to the success of any regulated business. Assessing employee skill levels is one way to see if employees are comprehending what they are learning.

Tissue Banking - Good Tissue Practices GTP - Regulations, Operations and Medical Oversight

An Interview with Ted Eastlund, M.D., by Robyn Barnes

Designing a Learning and Performance Program in Tissue and Organ Banking

Keeping up with the changes and the training in tissue and organ banking is an ongoing process. We know what works well and what doesn't. We know with a field-based staff that classroom training is difficult to pull off when trying to coordinate everyone's schedules and of course working around the case load. What we have found is that online learning or on-demand learning does work. This allows all of the staff to access training when and where they need it. We currently offer the following typ

How to Practice Quality Management in Your Personal Life

“Quality management” is one of those terms that sounds so simple and esoteric at the same time, like DNA or free cash flow. I’m pretty sure I know what those terms mean until I start explaining them to someone. 

When You Find Yourself Between a Rock and a Hard Place

We all have those days where everything that can go wrong, does. Where it seems the entire universe is working against you, testing your patience, your determination and your will to carry on. But in the scheme of things, are these so-called bad days really

The Most Important Four-Letter Words in ISO 9001:2015

Most organizations are well under way with the transition to the new ISO 9001:2015.  As such you should be very familiar with the emphasis on two four-letter words found throughout the document ….

Brave New World: The Mutual Recognition of CGMP Inspections

Last week, the United States and the European Union agreed to recognize each other’s drug cGMP inspections. The agreement reached (see

Supplier Approval Challenges Under FSMA

As a food safety and regulatory consultant, I work with diverse clients who face many different challenges with Food Safety Modernization Act (FSMA) implementation. The ones that are the hardest to address fall into the intersection between company policy and regulatory requirements. Supply-chain approval is a major challenge for many larger corporate clients, as well as smaller clients who must remain flexible to maintain profitability. The requirements of the Foreign Supplier Verification Prog

FDA Crisis: An Attrition of Brain Power

If people are an organization's greatest asset, the FDA's current ""people status"" is one of serious attrition.

How to Lead with Respect

“Over time I’ve come to realize that engaging in this problem-solving process is actually the highest form of respect….The manager truly respects the employee’s knowledge and his or her dedication to finding the best answer….Only by showing mutual respect-- each for the other and for each other’s role-- is it possible to solve problems, make work more satisfying, and move organizational performance to an ever-higher level.”

Supplier Qualification: An Important - and Often Neglected - Validation Component

Surviving Live Data Inspections by the FDA---3 Critical Success Factors

I have long been a supporter of being well prepared for FDA inspections, including how data is presented during the inspection. Historically, you’d print the files for FDA review rather than do a live demonstration of the database information. While I haven’t experienced it yet, it is my understanding that the FDA is now requesting a “live” data review. Essentially the expectation is for you to walk the inspector through your files and explain the information rather than have you print and organize paper files before they see it.

GCP Compliance: Eliminating Silos between Clinical Quality and Clinical Operations

In a classic episode of Seinfeld, George Costanza is terrified of the potential ramifications of his “worlds colliding” when his fiancée, Susan, becomes friendlier with his dubious pals Elaine, Kramer and Jerry. “Everybody knows you’ve got to keep your worlds apart,” George rants (but when does George not rant?) “If Susan is allowed to infiltrate this world then George Costanza as you know him ceases to exist. If Relationship George walks through this door, he will kill Independent George! A George divided against itself cannot stand!”

Factoring Regulatory Strategy into New Product Development

It is unfortunate that so many new medical devices and new generation product launches are delayed due to the absence of regulatory input at the beginning stages of design control and the new product development process.

Retraining and Refresher Training: Aren’t They One in the Same?

Ask an operations manager and he’ll acknowledge that what it’s called is less important than getting the “assignment” done and entered into the LMS. He’s usually more concerned about the loss of productivity during the training than the effectiveness of the training at that time. It isn’t until later when the training may have to be delivered again (repeated), that the comment “training doesn’t really work” is heard.

Pros and Cons of Proposed PDUFA IV User Fee Increase From FDA - For Pharmaceuticals

FDA Proposes PDUFA User Fee Increase to Boost Drug Safety

How to Use Postmarket Surveillance Data to Gain a Competitive Edge

Medical device companies are required to conduct postmarket surveillance (PMS) on their devices to maintain high product quality and safety. However, few companies realize the true value of the digital feedback they receive. In this post, we will explore current best practices for collecting and interpreting postmarketing intelligence, and discuss how you can use the information you acquire to gain a competitive advantage.

Is Compliance an Obstacle to Quality?

Can you distribute poor quality products while complying with regulatory requirements? Sure, after all, you can conduct a recall of poor quality products in compliance with all applicable regulations.

Labor Day by the Numbers: Life Sciences & STEM Edition

Did you know that science, technology, engineering and mathematics (STEM) job opportunities in the United States are expected to grow 17 percent by 2018? Or that 39 percent of hiring managers believe science and clinical workers are in short supply?

UDI: When the Rule is Not Enough

With less than two months to go before the UDI compliance date for Class II devices, on July 26, 2016, FDA issued a draft guidance related to what would seem to be the most basic of concepts: the form and content of the UDI. More specifically, the draft guidance states that its intent is to “clarify” for industry and FDA-accredited issuing agencies the form and content of the UDI, and to “better ensure the UDIs developed under systems for the issuance of UDIs are in compliance with” the UDI rule.