GxP Lifeline

How Social Media Is Advancing Healthcare

Facebook’s IPO last year received a lot of media attention. While the news was mostly financial, the huge sums of money being discussed were not the only numbers associated with the social networking site that can give pause. Facebook now boasts more than a staggering 1 billion users. To put that in perspective, that’if Facebook were a country, it would be the 3rd largest in the world. And while Facebook is the biggest, it’s not the only social networking giant. Depending what source you co

The European Qualified Person - What's It All About?

Note: The views expressed in this article are those of the author and do not necessarily represent those of the employer, GxP Lifeline, its editor or MasterControl Inc.

Business Benefits of Archiving

The word “archive” is springing up all over the world of IT and data management. Why now, and what are the implications to an organization working within the highly regulated world of a GxP environment? This article sets out some of the key business drivers around long-term data storage, and offers some lifelines to IT professionals drowning under a deluge of data.

One Year Later: The FSMA and the Food and Beverage Industry

A year has passed since the Food Safety Modernization Act (FSMA) was signed into law. Some of the changes envisioned under the FSMA are already in place, such as the FDA's new mandatory food-recall authority and the authority to detain food products that the agency has reason to believe are adulterated or misbranded.

FDA Sets New Priorities for Foods and Veterinary Medicine

Note: The views expressed in this article are those of the author and do not necessarily represent those of his/her employer, GxP Lifeline, its editor or MasterControl, Inc.

The U.S. Biosimilar Pathway Nearly Three Years Later

Note: The views expressed in this article are those of the authors and do not necessarily represent those of his/her employer, GxP Lifeline, its editor or MasterControl, Inc.

Trends in Q1 Warning Letters

If you work in the life science industry, it is always a good habit to periodically check the FDA's website for enforcement actions and warning letters. You can glean important insights from the mistakes and weaknesses of other companies in your industry, maybe even your competitors. You will see what the FDA is emphasizing in inspections, perhaps see some trends.

Surviving the Back Room During an FDA Inspection

During one of my early inspection experiences with the FDA, I found myself working with a team that felt it didn't need a backroom setup to review documents prior to bringing them to the investigator. Naively, I agreed to let the team move forward with the inspection. As the observer, I watched as things spiraled out of control.

Process Verification vs. Process Validation: What You Need to Know

Note: The views expressed in this article are those of the authors and do not necessarily represent those of their respective employers, GxP Lifeline, its editor or MasterControl, Inc.

What Does a New FDA Quality Office Mean?

The news that the FDA is creating a new Office of Pharmaceutical Quality probably set off the alarm bell for the industry. Does a new quality office mean new requirements? It’s the first question that comes to mind.

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

The Importance of Computer Systems I/Os Accuracy Checks

Note: The views expressed in this article are those of the author and do not necessarily represent those of his/her employer, GxP Lifeline, its editor or MasterControl, Inc.

How to Prepare your Design History File (DHF) for an FDA Inspection

FDA inspections strike fear into most companies, but most of the fear is due to a lack of knowledge about what to expect from the FDA. Therefore, the person responsible for the design control process at your company should read two important documents—in addition to this article:

FDA User Fees: What Have They Done for You Lately?

The U.S. Food and Drug Administration (FDA) user fees have been a fact of life for regulated industry for nearly two decades. Over the past 20 years, the Prescription Drug User Fee Act (PDUFA) has allowed FDA to speed up review times for new drug applications (NDAs) and biologic license applications (BLAs), ultimately decreasing the amount of time it takes drugs and biologics to reach the market.

FDASIA: Key Statutory Changes for Medical Device Companies

The Food and Drug Administration Safety and Innovation Act (FDASIA), enacted July 9, 2012, is the most recent statute impacting FDA's regulation of medical devices. FDASIA is significant not only because it reauthorizes user fees for device submissions, in exchange for FDA's commitment to achieve certain performance goals in the review of those submissions, but also because it institutes various other changes to the device regulatory framework. Several of these should or may benefit medical d

FDA Says Part 11 Guidance Remains Status Quo

Time and again, rumors surface about the possible update of the 2003 guidance on the scope and application of 21 CFR Part 11. The never-ending speculation attests to the enduring interest in Part 11, not to mention the continued scrutiny of the regulation.

FDA Issues Draft Guidance on Biosimilar Product Development

The views expressed in this article are those of the author and do not necessarily represent those of his/her employer, GxP Lifeline, its editor or MasterControl, Inc.

FDA Fields Tough Questions About Inspections

Note: The views expressed in this article are those of the author and do not necessarily represent those of his/her employer, GxP Lifeline, its editor or MasterControl, Inc.

FDA Compliance Officer: Industry, FDA Must Focus on Device Quality (Not Just Compliance)

Note: The views expressed in this article are those of the author and do not necessarily represent those of his/her employer, GxP Lifeline, its editor or MasterControl, Inc.

Is FDA to Blame for Biomedical Industry's Slow Growth

Given the global economic challenges today, it is understandable that the biomedical industry sees lack of funding as a key obstacle in growth. What is surprising is that the industry also sees the FDA and the current regulatory environment as a stumbling block.