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.
In my next few blog posts, we'll be covering user access and how it can impact data integrity. For starters, let's explore the Principle of Least Privilege. What is it? What happens when it's violated? Finally we'll map out five actions you can take to protect your company.
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.
January 13, 2015
By Laurie Meehan, Social Media Manager, Polaris Compliance Consultants
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.
December 11, 2014
Matthew M. Lowe, Executive Vice President, MasterControl Inc.
Medical device manufacturers rely on suppliers for many things. Choosing the right vendors and managing them effectively can increase a manufacturer’s efficiency—in terms of time, cost, and quality. Unfortunately, suppliers can also sometimes put their clients in hot water when their quality standards are below par.
October 23, 2014
By Holly DeIaco-Smith, MS, HDS Consulting
Don’t get me wrong, these skills are important and they are point of entry for a good CRA. These skills are expected as a minimum set of skills to be hired for the job of CRA but they are not the skills that differentiate a great CRA.
October 2, 2014
By Paul Sanderson, Solutions Consultants Manager, MasterControl
Effective project management helps your company save time and money by keeping projects on time and on budget. It optimizes your resources by assigning the right people with the right skills for every project. In a regulated environment, you need all of these, plus one more crucial consideration: compliance.
September 25, 2014
By Marc C. Sanchez, Contract In-House Counsel & Consultants, LLC
Good Manufacturing Practices (GMPS or cGMPS) are a bit of a misnomer. The name implies the practices only apply to manufacturers, but the limitation is in name only. It suggests a rigid system of procedures more suitable for multinational corporations than start-ups, mid-size companies, or importers.
Each year, the most popular learning course we provide is targeted at developing the skills necessary for our customers’ associates to implement their corrective action programs effectively and efficiently. Throughout the years, we have been asked the same question hundreds of times, “What are the most common reasons corrective actions fail?” Usually this question is asked during the corrective action learning session by a management team member hoping that we will deliver the message to the other team members that they are failing. Normally, we turn the question back around to the group and ask them why they think their corrective action program fails. The most common answers we hear are: limited time, resources, training, or not knowing which tools to use.
The global healthcare and healthcare service market will maintain steady growth due in large part to an aging population that is living longer and to improved healthcare services in emerging markets that include China, Brazil, India, Japan, Israel, and South Korea, among others. It is interesting to note that countertrends seem to be developing in the medical device space; for example, hospital utilization of medical devices has slowed significantly, reimbursements continue to tighten, and there was a first-time global decrease (5%) in US premarket approvals (PMAs) in 2012, a trend that continued into 2013. There were also fluctuations in investor healthcare spending across 2012, drops in mergers & acquisitions deal value and deal counts, and a device tax that is adding to the squeeze.
July 15, 2014
By Joyce L. Frey-Vasconcells, Executive Director, PharmaNet Consulting, PharmaNet Development Group, Pharmanet.com
More and more companies are developing combination products for many life-threatening and unmet medical needs. One area that holds much promise is the development of tissue engineered products which contain living cells or tissues combined with a device. As with any novel technology, questions regarding what the requirements will be by the regulators to obtain market approval is always an issue. This has been a changing dynamic in other parts of the world but the Food and Drug Administration
July 15, 2014
By Robert Packard, Regulatory Consultant, MedicalDeviceAcademy.com
Responding in 15 days is one of seven steps on how to respond to an FDA 483 inspection observation. This blog post also includes advice from a former FDA investigator.
July 7, 2014
By Seth Mailhot, Lead, FDA Practice, Nixon Peabody LLP
The signing of the historic healthcare reform legislation will have a significant impact on both the medical device and pharmaceutical industries. A significant increase in the number of individuals carrying health insurance will translate into a greater demand for medical devices and pharmaceuticals. While this will improve profitability for many companies, it will present challenges to manufacturing and quality managers tasked with finding ways to quickly increase production.
June 19, 2014
By Jon Beckstrand, CEO, MasterControl
MasterControl has grown our reach significantly over the last 10 years—from a small provider of a narrowly focused document control product to one of the largest organizations in the world focused on helping quality and compliance professionals achieve their purpose. I have met with many of the world’s top quality professionals over the past 10 years and I have been amazed by their devotion and commitment. I have recently found myself asking the question: What drives these dedicated people? Why are they so passionate about their jobs? I believe I have found the answer and it has had a strong effect on how I view MasterControl’s mission.
June 15, 2014
By Robin Nozick, MT(ASCP) CTO and Founder of R.F. Nozick and Associates
The blood establishment bears the responsibility for the regulatory compliance of the automated/computerized systems used. Full validation of the computerized system is required for systems critical to product and quality (information management, storage, tools for operational decision-making, and control). The Quality Risk Management approach to validation advocated by GAMP 5 and ICH Q9, a life cycle approach within the QMS, and the use of risk assessments to define the validation strategy for
May 29, 2014
By James Jardine, GxP Lifeline Editor, MasterControl
Every provider of electronic quality management systems claims its product will give you a significant return on your investment. But how can this ROI be truly measured? To find out, MasterControl recently surveyed customers to learn more about their levels of waste and efficiency before and after implementation of MasterControl's quality management system (QMS). Some of the results of the survey are compiled here in an informative infographic.
April 3, 2014
By David Lim, President and Principal of Regulatory Doctor, and Yoonhee Beatty, Regulatory Affairs Associate, Bard Access Systems, Inc.
We present a summary of available options to request additional review of FDA decisions or actions, including how to choose an option when a stakeholder has reasonable grounds to disagree with FDA/CDRH’s decision. It is worthwhile to note and get familiarized with the available options. However, it is recommended the stakeholder try to avoid having such situations in the first place.
March 26, 2014
By John E. Lincoln, J.E. Lincoln and Associates LLC
Companies that choose to produce medical products come under the regulatory laws of the countries in which they market their products. For the U.S., this falls under the purview of the U.S. FDA, with its CGMPs, “Current [best practices] Good Manufacturing Practices”, as codified in 21 CFR 4, Combination Products, 21 CFR 111, Dietary Supplements, 21 CFR 211, Pharmaceuticals, and 21 CFR 820, Medical Devices, and others.
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