GxP Lifeline

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

PFDA, Community Meets to Discuss Priorities Article

Reviews issues discussed during a recent meeting of FDA and blood community representatives where the two groups presented and reviewed issues important to their operations.On Oct 04, 2007, Food and Drug Administration (FDA) staff met with AABB’s FDA Liaison Committee in Bethesda, MD, to discuss topics of mutual concern in the areas of donor and patient safety. The committee includes liaisons from AABB, the American Red Cross (ARC), America’s Blood Centers (ABC), Advanced Medic

What To Expect After an FDA Inspection

From blood supply to vaccines — blood establishments and biologics companies handle complex products that are fundamentally important to human life. It is no wonder that the industry faces some of the toughest regulations and standards today.

Blood & Biologics Articles and Industry News Portal

Four Things You Need to Know About FDA's Guidance for Tissue Establishments

FDA Reminds Manufacturers About Their GTP Responsibilities

FDA Guidance Pertaining to Certain HCT/Ps: Three Recommended Actions

FDA Issues HCT/P Guidance

Increasing Efficiency Through Lean Principles

In today's economy many not-for-profit organizations have seen reserves eviscerated due to the stock market tumble. While the stock market has started to rebound, many not-for-profit agencies have also taken a hit on the philanthropic side. Donors are not able to be as generous as they have been in the past. The reserves that not-for-profits have been able to rely on to supplement operating funds are not there anymore. This has forced many organizations to look for other ways to reduce costs. W

ISTB 128 Sets Industry Safety Standard

The key to satisfying these requirements lies in standardization: globally unique identifiers for products, standardized terminology and a means to convey information electronically that is recognized by computer systems throughout the world. Towards this end, ISBT 128 had been developed.

5 Ways to Ensure System Compliance with 21 CFR Part 11 - MasterControl

Site Selection: Don’t Forget About the Study Drug

As a sponsor or CRO, you understand the importance of a thorough site selection process. A site needs to be able to meet enrollment targets and timeframes, protect the rights and safety of study participants, execute the protocol, deliver quality data, and maintain GCP compliance. That’s what your site feasibility surveys and pre-study visits are designed to evaluate. And as you’re assessing a site’s abilities, the site is conducting its own feasibility process. They’re mining their patient data

Top 5 Takeaways from MedTech Intelligence’s Medical Device Cybersecurity Conference

I recently attended a conference on Medical Device Cybersecurity hosted by MedTech Intelligence held March 23-24, in Washington, DC. It’s evident that cybersecurity is an important concept as attendance, both in-person and remote, was high. Conference organizers lined up a powerhouse group of presenters who are all entrenched in the technology, cybersecurity, legal and regulatory compliance industries.

4 Rules for Building an eClinical Qualification Framework

As clinical trials continue to expand globally, technology plays a critical role in maintaining data integrity and at the same time accelerating study start-up. Consider a study management team that must travel globally to hold investigator meetings. Travel now takes up a much greater portion of the study management team’s time and energy.  That’s why study teams have turned to eClinical technology to reduce this effort – from preclinical R&D and regulatory communication to packaging/di

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. 

5 Warning Signs of Diminishing Supplier Quality

supplier’s quality system doing what it’s supposed to be doing? Would you know if it weren’t? How would you know if there were flaws in your supplier’s quality processes before the problems get worse? These are the questions MasterControl’s Terrance Holbrook attempts to answer for medical device manufacturers in a recently published post on MDDI’s Device Talk blog.

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

FDA Guidance Answers Questions Regarding Data Integrity

An alarming increase in CGMP violations involving data integrity has come to the attention of FDA. To spotlight this issue, the regulatory watchdog has drafted a question-and-answer-based guidance, “

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 ….

FDA Eager to be Innovative Partner with Expedited Access Pathway

Part of FDA’s prime directive is to assure the safety, effectiveness and quality of biological products and medical devices. So the notion of FDA endorsing the acceleration of product development might raise some eyebrows. However, FDA officials and industry experts alike seem to agree that with some patients waiting is not the hardest part, it’s actually not an option.

The Inner Game of Continuous Improvement

by Tim Gallwey for helping him overcome anxiety and self-doubt, and to keep winning. I read the book looking for parallels and general lessons that could be applied to workplace performance and continuous improvement, and was not disappointed. Here is a summary of what I learned about what I will call “the inner game of continuous improvement.”

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