May 12, 2016
By David Butcher, Staff Writer, MasterControl
Even after an FDA investigator has completed an inspection at your facility, there’s still plenty of work that remains. At the conclusion of an audit, the inspector will hold an exit interview to discuss observations and present significant findings on a Form 483. What do you do next?
May 5, 2016
By Dave Hunter, Product Management Director, MasterControl
A recent warning letter to a medical device firm shows the importance of proper documentation of cleanroom maintenance procedures and corresponding control of those documents. The FDA noted the company’s failure to establish and maintain written procedures for avoiding contamination of equipment, as well as the incongruity between some of its cleanroom procedures and records of actual practice (1).
April 19, 2016
By Mark Schwartz, Director, Hyman, Phelps & McNamara
There have been at least four FDA initiatives, in the works for some time that, in the coming years, will change the way pharmaceutical (and indeed all FDA) inspections are conducted. We think you should know about these initiatives, and how they are likely to affect the way companies prepare for, and deal with, FDA inspections. Today, we are going to discuss the Program Alignment Group (PAG) plan, arguably the least controversial of the four. Over the next few weeks we will discuss the other three programs that are likely to dramatically affect the inspection landscape.
April 14, 2016
By Beth Pedersen, Staff Writer, MasterControl
With so many international regulatory bodies governing different countries and industries, it can be difficult for manufacturers to stay abreast of all of the changing regulatory environments and requirements across the globe. On August 5, 2015, China Food and Drug Administration (CFDA) released its “Principle of technical review of medical device software” (2015 Order No. 50). The principle, which is only available in Chinese, signals a major change for documentation requirements for stand-alone software or software components developed by medical device manufacturers or their development partners.
April 12, 2016
By Matthew M. Lowe, Chief Product & Marketing Officer, MasterControl
Design control issues represent a key challenge for many medical device firms. This is the reason why in 1996, the U.S. Food and Drug Administration (FDA) added design control principles to 21 CFR Part 820 and required rigorous documentation to demonstrate design control.
March 1, 2016
By Beth Pedersen, Staff Writer, MasterControl
Just like every other aspect of a product, quality is determined by the decisions you make in the design stages. While spending less time on planning upfront might seem to save you money, the costs associated with poor quality resulting from early design decisions can ultimately equate to 40 percent of your company’s total revenue. Correctly understanding the true nature of quality and addressing it in the design stages rather than trying to bring it in as an afterthought is the central premise of Quality by Design (QbD), and adhering to this principle could be the most cost-saving measure your company will ever take.
February 18, 2016
Howard Sklamberg, J.D., Jeffrey Shuren, M.D., J.D., and Melinda K. Plaisier, M.S.W., Food and Drug Administration
Across FDA, we are devoting tremendous effort, in collaboration with a variety of stakeholders, toward activities that drive–and increase–product and manufacturing quality. We believe quality can be quantified through close attention to data and consistent review and analysis of that data, which in turn can promote the practice and culture of quality within firms.
February 4, 2016
Paula Gray, Navigant & Sharon Kvistad, Navigant
Many industries including automotive manufacturers, NASA, information technology systems, and countless others suggest or even require implementation of a Quality Management System (QMS) in order to ensure products are manufactured to a high quality standard. For products like medical devices, QM systems ensure that products are not only of a high quality, or deemed “effective” to perform as they are intended, but are also safe for their intended use.
January 26, 2016
By Martin Browning, President and Co-Founder, EduQuest
Although FDA is strapped with limited resources and competing priorities, the Agency continues to hammer regulated companies with FDA 483 inspection observations and Warning Letters.
December 31, 2015
By Laurie Meehan, Social Media Manager, Polaris Compliance Consultants
The most substantial change to international guidelines in 20 years occurred earlier this year when the ICH* issued a draft addendum to its GCP guidelines, ICH E6(R2).
November 5, 2015
By Holly DeIaco-Smith, MS, HDS Consulting
In the role of a consultant, you have the benefit of seeing what works well across your client base and their shared common pain points. Because of this perspective, I’m often invited onto a project to provide guidance on best practices and practical advice on how to avoid the common pain points.
November 3, 2015
By Marci Crane, Staff Writer, MasterControl
Although a long list of candidates make up the list of “eligibles” for the 2016 Presidential election, it’s fairly apparent that the two most conspicuous candidates are, respectively, Democrat Hillary Clinton and Republican Donald Trump. These two candidates, though liked and disliked by various population pockets across the United States, have certainly managed to make names for themselves within their various areas of expertise.
September 30, 2015
By David Butcher, Staff Writer, MasterControl
In recent years, a swing in public perception has led to widely held misconceptions of United States manufacturing – that modern manufacturing environments are dark, dangerous and antiquated factories designed for low-skilled workers.
September 15, 2015
By David Katzoff, Managing Director of Product Development and Chief Architect for Valiance
Compliance and business risk plays a significant role in the implementation methodologies of corporate information systems. Further, the compliance and business risks associated with these corporate information systems are, in general, well known. However, as part of the implementation process many of these information systems will be populated with legacy data. The compliance and business risks associated with migrating this legacy data and content into a new system are not necessarily understo
Northeast Baptist Hospital in San Antonio, Texas has adopted a perioperative blood management program, aiming to perform 90% of surgeries without blood transfusions. The hospital has received support from the South Texas Blood & Tissue Center, which says bloodless facilities help ease the demand for blood and tissue donations.
In 2014, reimbursement trumped regulatory as the industry’s biggest concern.1 As we move further into 2015, it remains at the forefront of stakeholders’ minds. In its 2015 Medical Device Industry Survey, Emergo asked 636 presidents, CEOs and managing directors of medical device companies what issues were keeping them up at night, and reimbursement challenges ranked in the top three.2 In this era of health care reform, device makers are under intense pressure to develop products that demonstrate not only clinical efficacy, but also real value (i.e., lower costs and better outcomes) in order to secure coverage and attract risk-averse investors. In this post, we’ll examine some of the most common reimbursement policy challenges and discuss strategies for putting them to rest.
July 28, 2015
By Kelly Thomas, Atlantic Validation
Successfully completing a FDA inspection is critical to cGMP operations and commercial success. Implementing and maintaining robust quality systems is one element to accomplishing this goal. However, it is not the only element. Inspection preparation and management is another, equally important element to ensure a successful outcome. In fact, proper Inspection management techniques can help mitigate the risk of receiving an observation for compliance gaps. This article will provide insight on understanding the inspector, discuss how to prepare for and manage the actual Inspection, describe follow-up activities required for close-out, as well as describe real-life lessons learned.
July 7, 2015
By Carl Anderson, Regulatory Affairs and Quality Assurance Consultant
During the time I was an FDA field investigator I encountered many clinical investigators who were totally unprepared for the FDA inspection. I would receive a "deer gazing into the headlights" response from the PI who obviously didn't remember a thing about the audited study. There is an old saying, "you only get one chance to make a good first impression." Often they would turn to their study coordinator and ask for the answer, joking to me, "They do all the work anyway."
The proposal—whether it will soon be implemented or not—has manifested the obvious drive FDA has toward automated systems. For example, once FDA is fully automated industry will have two options for electronic submission of MDRs including one for low volume reporting and another for its high volume counterpart. Industry will also benefit by ""doing business"" with an agency that will be far more efficient in terms of data collection, response, feedback and analysis. Those benefits alon
June 2, 2015
By Dr. Bob Strong, SAI Global Assurance Services
A thorough and effective CAPA can provide many benefits such as providing long-term solutions, preventing recurrences, fostering continuous improvement, improving customer satisfaction, improving profitability, and having the ability to influence FDA and FSMA inspections.
