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Featured Articles

July 2012

Mark Kramer

Challenges in Combination Product Regulation

by Mark D. Kramer
President, Regulatory Strategies, Inc.

Combination products raise a variety of regulatory challenges. In addition to the unique technological and scientific challenges these products may raise, when drugs and devices, drugs and biologics or devices and biologics are combined to create a new product, consideration must be given to what regulatory requirements will apply to the combination product as a whole. This article explains the key principles and processes established for the assignment, premarket review, and postmarket regulation of combination products in the United States.

To address the perception that combination products often "fell through the cracks" between the three medical product centers (CBER, CDER and CDRH), in 2002 Congress mandated that FDA establish the Office of Combination Products (OCP). This small office, organizationally located in FDA's Office of the Commissioner, has several key functions to help clarify the regulatory challenges. OCP's key roles are to serve as FDA's "traffic cop," determining which FDA Center will lead the review process for combination as well as non-combination products; to oversee the timeliness of combination product reviews (however, primary responsibility resides with the lead center to which the product is assigned); to serve as a resource for industry and FDA staff on combination product issues; and to develop policy and regulations to clarify combination product issues.

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Vivian Bringslimark

100% Training Complete ≠ 100% Effectively Trained

by Vivian Bringslimark
President HPIS Consulting, Inc.

"Can you run me a training report? I need to know where we stand with our training effectiveness program!" For a training manager, this is a double-edged sword. While it is very encouraging that upper management is taking an interest in the training program, focusing merely on the percentage of completion does not measure training effectiveness.

Yes, it is a starting point. Because without the records, it's only a rumor that training happened at all. But relying solely on the metric as a measure of training effectiveness, executive management creates a false sense of security. All it does is confirm that 100% of the training events were documented. Enter a checkmark in the box. But checkmark 2 needs to occur as well. Can the employees do their assignments according to written procedures? The very procedures they signed for? This is the essence of training effectiveness.

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Regulations Vary Worldwide but Risk Management is Common Denominator

by Cindy Fazzi
Marketing Communications Specialist, MasterControl, Inc.

To compete in today's global market, regulated companies must comply with innumerable requirements, directives, and standards coming from regional, national, and international bodies. While these requirements vary based on industry and the regulatory body involved, they do have a common denominator—emphasis on risk management.

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Patricia Santos Serrao

Regulatory Submissions: Filling the Critical Gaps in EDM Systems

by Patricia Santos Serrao
Senior Product Manager, Pharmaceutical Industry, MasterControl, Inc.

It's been said that electronic document management (EDM) systems for the management of submission documents are "a dime a dozen." However not all EDM systems are created equal, at least not when it comes to the management of final submission documents. Many of us are familiar with the standard functionality that most EDM systems provides particularly in the life sciences space such as: document types, taxonomy, version control, lifecycle management, securities, PDF rendering, watermarks, and electronic signatures just to name a few.

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Did you know that clinical trial sponsors are spending up to $5 billion in unnecessary, non-core procedures? A new study found that up to 25 percent of all clinical trial procedures were non-core, which means they were not directly tied to the clinical trial endpoints that demonstrate drug safety."
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