FDA Issues New Draft Documents Related to Compounding of Human Drugs

The U.S. Food and Drug Administration has issued five draft documents related to drug compounding and repackaging that will help entities comply with important public health provisions. The draft documents are applicable to pharmacies, federal facilities, outsourcing facilities and physicians.

6 Ways to Ensure Your QMS Meets FDA and ISO Compliance

An optimal quality management system (QMS) is the foundation for long-term regulatory compliance, especially for organizations working within strict U.S. Food and Drug Administration (FDA) and International Organization for Standardization (ISO) environments. Those lacking a solid quality infrastructure are simply not equipped to face the challenges of the regulatory environment and meet the demands of a competitive market.

Draft Guidance on Good Manufacturing Practices for Combination Products – FDA Delivers on Promises

Two years ago, in January 2013, FDA published the final regulations on Good Manufacturing Practices for Combination Products.[1] These regulations are built on the concept that the constituent parts of a combination product retain their regulatory identity as a drug, device, or biological product, even after they are physically, chemically, or otherwise combined into a single-entity combination product (i.e., prefilled injector or drug eluting stent) or co-packaged together.[2] Therefore, all the good manufacturing requirements associated with each constituent part must be complied with in the manufacture of single-entity and co-packaged combination products.

The Perks of Pursuing a Career in Quality Management

It is a bit of a mystery to me that more is not made of the personal career advantages and knowledge gained from performing procedural assessments, audits and other quality management related functions. For me personally, this type of activity has been one of the key factors in my career progression and advancement.

Success By the Numbers (or Why Being Science-y is a Good Thing)

How do you know if you know? In other words, how do you know when you have sufficient knowledge to reliably manage or improve a process? This last question reveals the foundation of all quality, regulatory, and compliance work.

FDA Audit Practices: the 10 Most Commonly Cited Drug GMP Deficiencies of 2012-2013

If there is one word within the life science industries that causes concern and anguish it is “audit.” As with any evaluation process, the success of getting through a regulatory audit is a combination of preparedness with regards to what to expect, knowing the current regulations that apply to your product and knowing what tends to be the areas of deficiencies in audits performed. All of these items can be researched on the web and the time and effort to review and provide training on them will serve companies well.

CAPA Should Not Be a Dreaded Four-Letter Word

In a regulated environment, CAPA is a requirement for addressing and mitigating deviations and nonconformances. A quick review of FDA warning letters indicates it’s a dreaded four-letter word for many companies cited for violations.

Murray Explains ISO 9001 Update at MD&M West

Murray is a frequent MD&M West speaker who is a recognized authority on ISO 9001.  He's authoritative and entertaining, so this is a session you won't want to miss.

Measuring Risk Management Outcomes

In his book Decision Making: Risk Management, Systems Thinking and Situation Awareness, Dr Alan McLucas introduces the concept of the Risk Management Paradox: “The task of managing risks effectively is confounded by a classical paradox. That is, if risks are being effectively managed as a matter of routine, there will be very few surprises. Nobody becomes aware of just how effective careful risk-management actions have proven to be. Nobody slaps the manager on the back and congratulates them for a job exceedingly well done. In stark contrast, however, if risks are managed poorly, the whole world lines up to say so.”

Risk Management in Clinical Research: Process and Application

Recently, two key pieces of guidance were released from Food and Drug Administration (FDA) and European Medicines Agency (EMA) regarding risk based approaches to clinical research. These documents include FDA’s “

Med Device Excise Tax Debate: Let Your Voice Be Heard

Since January 2013, medical device manufacturers and importers have been paying a 2.3 percent excise tax as part of the Affordable Care Act. The tax is assessed regardless of the company’s profitability.

Getting Ready for ISO 13485:201X (Part 1)

As most of you know, ISO 13485–Quality Management Systems—Requirements for Regulatory Purposes is being revised. ISO 13485:201X, as the final revision is being referred to, is expected to be available in late 2015 or early 2016. Understandably, this is causing anxiety for medical device manufacturers, many of whom are still struggling to conform to the current version of the standard. With this in mind, let’s review the basics of the ISO: 13485. In future posts, we’ll examine why the standard is being updated, and the most significant changes you can expect to see.

Five Steps to Building Process Efficiency with Your Supplier

In order to achieve success with your outsourced manufactured medical devices, there must be cohesiveness between the manufacturer (Supplier) and the product developer (Customer). I’ve exemplified this role as that of the supply chain liaison consultant, involved directly with the development of the manufacturing processes, while in step with the roll-out of the product design intent. This article will discuss the five steps required to accomplish all of this while defining the role of the consultant. The consultant provides the tools and leadership to maximize the value of the supplier in their partnership with the customer.

Setting an Organization's Risk Management Context

There is considerable confusion in the risk world in relation to terms such as risk appetite, risk tolerance, risk acceptance, risk threshold and risk attitude (just to name a few).  These are defined differently by organisations and there is no guidance in ISO 31000 that clarifies this, so the confusion becomes a distraction.

What Does Risk-Based Monitoring Mean for QA Auditing?

By now, we all know that risk-based monitoring (RBM) isn’t just about changing the role of the clinical research associate (CRA); it’s transforming the way clinical studies are managed. So what does that mean for quality assurance (QA) teams who audit these new processes? Polaris president Celine Clive led a roundtable discussion about RBM and its implications for auditing at November’s North Carolina Regulatory Affairs Forum (NCRAF) meeting.

Enter The Digital Risk Officer

In the brave new world of digital risk management, a CISO would report up to a DRO who manages risk from a business perspective and works with peers in business operations, compliance and IT security.

Risk Management: A Primer for Lean Quality Assurance

In this article, we will take a closer look at what is becoming perhaps the most useful tool in the belt of today’s quality professionals: risk management.

Enjoy a Quality New Year!

Stedman Graham Steps Out of Oprah’s Shadow, Shares Secret to His Success

Stedman Graham, CEO of S. Graham and Associates and a best-selling author of motivational books, shared the secret to his success. No, it’s not Oprah, though he’s widely known for his long-time relationship with one of the world’s most famous media personalities. 

Navigating the New FDA Draft Guidance on ISO 10993: Biological Evaluation of Medical Devices

As part of FDA’s efforts to harmonize their requirements with those around the world, it has issued a number of guidance documents to help explain the agency’s position, especially in cases where FDA has some variance with a given international standard.  The current FDA guidance regarding biological evaluation of medical devices,