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.

Failure of Management with Executive Responsibility

For the second time in three weeks, Dr. D was able to quickly locate another rarely cited Form 483 observation: The failure of management with executive responsibility to actually review the quality management system they have been entrusted with managing. Now granted, from time-to-time it becomes a challenging task for the management representative to circle the wagons and corral all of the management-types into the executive conference room for a meeting focused on the performance of the quality management system (QMS).

Thermo Fisher Unit Thrives Thanks to Streamlined Document Management

Call it the curse of success: as Unity Lab Services—a business unit of Thermo Fisher—flourished, the already massive amount of vital documentation that required tracking, continual updating and maintenance became exponentially larger and more difficult to manage. For a company that has obtained its leading edge by providing customers with a single source for integrated lab services, support and supply management, the very notion of out-of-control documents and outdated, rogue work instructions spelled potential disaster.

The Dude Abides! 5 Quotes from “The Big Lebowski” that Apply to Quality

“The Big Lebowski” never fails to make me laugh. The 1998 cult classic, starring the indefatigable Jeff Bridges, features some of the most quotable lines in film. Saying them is enough to break the ice among strangers at a party. In my family, the quotes are inside jokes that never grow old.

SWAT SOP Best Practices

SOP revision. It falls somewhere between income tax prep and colonoscopy prep on the likability scale. So why would you want to read about it? Maybe you’re hoping someone’s figured out a way to make the process more efficient and less painful. Maybe we have.

Five Reasons Why TMF Training is Important

Training is a vital component of workplace efficiency especially when it comes to one of the most important deliverables of a clinical trial – the Trial Master File (TMF). Perhaps that’s why, according to a recent article in Forbes magazine, U.S. companies spent over $70 billion on corporate training in 2014, an increase of 15% over the previous year. If you are lucky enough to oversee the TMF, you spend so much time bringing the right employees on board, it only makes sense you would understand the importance of providing them with the proper training to ensure your TMF is always inspection ready.