• CLIA vs QSR (What You Don’t Know Can Hurt You)

    4 February, 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. For all laboratory testing, Congress passed the Clinical Laboratory Improvement Amendments (CLIA), in 1988, which established quality standards to ensure the accuracy, reliability, and timeliness of patient test results regardless of where the test was performed. The Centers for Disease Control and Prevention (CDC) and the Centers for Medicare & Medicaid Services (CMS) published final CLIA Quality Systems laboratory regulations that became effective April 24, 2003.

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  • The FDA Just Called! Are You Ready for an Inspection?

    27 January, 2016 David R. Butcher, Marketing Communications, MasterControl

    If the U.S. Food and Drug Administration (FDA) called tomorrow to schedule a visit to your facility, would you go into panic mode or would you go on with your day, business as usual? For many, an FDA inspection can be a scary prospect. It can be extremely difficult, and failing it can have significant consequences. With proper preparation, however, the FDA’s call to schedule an inspection doesn’t have to be a nightmare scenario.

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  • Do You Really Want to Be An Executive In An FDA-Regulated Company?

    14 January, 2016 James R. Phelps, Hyman Phelps & McNamara, P.C

    Last Thursday, at the 16th Pharmaceutical Compliance Congress and Best Practices Forum, Principal Deputy Assistant Attorney General for the Justice Department’s Civil Division, Benjamin Mizer, reviewed enforcement policies that the Department of Justice will follow. Appropriate to the forum, he focused on the industries regulated by FDA. The emphasis he gave to the requirements for settling civil and criminal cases brought against organizations gives sharp focus to the problem of doing business when governed by a law that operates with a malum prohibitum standard of liability, a law that permits findings of criminal guilt without proof of intent or guilty knowledge.

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  • The Drug Supply Chain Security Act: Current Impact

    9 December, 2015 David Dills, Sr. Consultant, Regulatory & Compliance, Devices NovusLife

    On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 (DQSA) into law, bringing a successful conclusion to efforts by the industry and consumer groups to create a national pharmaceutical serialization and track and trace regulation, one that eliminated the patchwork of state laws in addition to providing new regulations for compounding pharmacies. This is the most complex pharma track and trace law ever passed.

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  • What Is a Food Safety Plan and What Is It Doing on My Table?

    22 September, 2015 W. Lynn Hodges, HACCP Consulting Group, LLC

    Whenever you go out to eat with your family, co-workers, or friends, you may be unaware that many of the restaurants (food service establishments) and retail food stores have some type of food safety plan in place. Most of the chain restaurants have sophisticated food safety systems designed and implemented for their daily operations and as well as many of the larger, more established restaurants and retail food stores. The U.S. Food and Drug Administration encourages these retail food operations to implement food safety systems and use them throughout the everyday activities of the operations.

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  • FDA Requests Public Input on Quality Metrics Guidance

    27 August, 2015 Oliver Wolf, Senior Product Manager, MasterControl

    In line with the general shift towards risk-driven approaches in the quality management world, FDA is now taking steps towards applying those same principles to its own auditing schedule. At the end of July, the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) released the draft guidance “Request for Quality Metrics” and is now seeking public input by September 28, 2015 on a number of key points.

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  • Infographic: FDA Inspections By The Numbers

    25 August, 2015 Tony Chen, CEO and Co-Founder of FDAzilla

    Up until recently, it has been difficult to get data on FDA inspections. Sure, the FDA publishes aggregate data every year, but what about the granular data on every inspection?

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  • Unique Device Identification (UDI): Much More Than Just a Label

    11 August, 2015 Beth Pedersen, Marketing Communications Specialist, MasterControl

    Labels are everywhere. Virtually every manufactured item is labeled with product information, and even fresh produce from the grocery store often bears a scannable barcode and ID number. Not only are things labeled, but people, too – any visit to the hospital comes with a bracelet displaying your personal medical details, identification information and a barcode. For the most part, we have become so desensitized to barcodes and labeling information that we rarely pay it any attention; presented in the form of random lines and number series, it can seem completely meaningless to us.

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  • Three Keys to Successful FDA Inspections – Preparation, Management and Follow Up

    28 July, 2015 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.

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  • European Supply Chain: A Series of New Regulations in Force

    21 July, 2015 Wolfgang Schmitt, Director Operations, CONCEPT HEIDELBERG GmbH

    The new EU Directive 2011/62/EU and its delegated acts keep on changing the pharmaceutical supply chain. The directive introduced numerous Delegated Acts with different time schedules and had some impact on revisions of several chapters of the EU-GMP Guidelines.

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  • FDA Regulation of HCT/Ps – Impact of New Guidances on Manufacturers and Users

    11 June, 2015 Stacie L. Ropka and Chad A. Landmon Axinn, Veltrop & Harkrider LLP

    What does the Food and Drug Administration (FDA) consider to be “minimal manipulation” and how are human cells, tissues and tissue-based products (HCT/Ps) made from adipose tissue regulated by FDA? These questions were addressed in two draft guidances issued by FDA in late December of 2014. The first, Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations (1), focuses on how adipose tissue is defined and thus how adipose-based HCT/Ps are regulated by FDA. The second, Minimal Manipulation of Human Cells, Tissues and Tissue-Based Products (2), focuses on the types of cell and tissue processing that would be considered more than minimal manipulation, resulting in the regulation of the cell or tissue-based product as a drug, biologic or medical device. Although they are not yet final, these guidances shed light on FDA’s current thinking and may signal that FDA will make it more difficult for products to be regulated solely under Section 361. Not only will such a position by FDA impact development of new HCT/Ps, but it could threaten the regulation status of currently marketed HCT/Ps.

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  • EU vs US: What are the New Track and Trace Requirements?

    4 June, 2015 Wolfgang Schmitt, Director Operations, CONCEPT HEIDELBERG GmbH

    In 2011, the European Commission published Directive 2011/62/EC, the so-called Falsified Medicines Directive (or FMD).One goal was the fight against counterfeit medicines through serialization and verification. In 2014 the technical characteristics of these key ideas were defined, the unique identifier (UI), delivering the possibility of verification of the authenticity of single folding boxes. The unique identifier contains information on the:

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  • Top 5 Medical Device Trends That Will Dominate 2015

    29 April, 2015 Lisa Weeks, Marketing Communications, MasterControl

    More connected and consumer-driven than ever before, the medical device industry is in the middle of a truly transformative year. Three-dimensional printing, mobile health apps, and other disruptive technologies are changing the way providers deliver care and prompting regulators to re-examine their roles. Consumers are demanding more transparency and convenience but are also concerned about the security of their medical information. Investors and stakeholders are paying closer attention to reim

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  • Regulatory Tools Go UFO: Useful, Free & Online

    7 April, 2015 Laurie Meehan, Social Media Manager, Polaris Compliance Consultants, Inc.

    Despite your best efforts, if you’re active in social media, you’ve been drawn into pointless conversations.  Indeed, that’s why many people stay away.  But if you can tolerate a little noise, I’ve found that the fruitful far outweighs the fruitless.  Case in point:

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  • FDA Launches Drug Shortages Mobile App

    4 March, 2015 Christopher Kelly, FDA CDER Trade Press

    Today, the U.S. Food and Drug Administration launched the agency’s first mobile application (app) specifically designed to speed public access to valuable information about drug shortages.

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  • FDA Issues New Draft Documents Related to Compounding of Human Drugs

    23 February, 2015 MasterControl

    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.

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  • 6 Ways to Ensure Your QMS Meets FDA and ISO Compliance

    19 February, 2015 David R. Butcher, Marketing Communications, MasterControl

    An optimal quality management system (QMS) is the foundation for long-term regulatory compliance, especially for organizations working within strict U.S. Food and Drug Administration (FDA) and International Organization for Standardization (ISO) environments. Those lacking a solid quality infrastructure are simply not equipped to face the challenges of the regulatory environment and meet the demands of a competitive market.

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  • Draft Guidance on Good Manufacturing Practices for Combination Products – FDA Delivers on Promises

    18 February, 2015 Suzanne M. O'Shea, Counsel, Faegre Baker Daniels LLP

    Two years ago, in January 2013, FDA published the final regulations on Good Manufacturing Practices for Combination Products.[1] These regulations are built on the concept that the constituent parts of a combination product retain their regulatory identity as a drug, device, or biological product, even after they are physically, chemically, or otherwise combined into a single-entity combination product (i.e., prefilled injector or drug eluting stent) or co-packaged together.[2] Therefore, all the good manufacturing requirements associated with each constituent part must be complied with in the manufacture of single-entity and co-packaged combination products.

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  • FDA Audit Practices: the 10 Most Commonly Cited Drug GMP Deficiencies of 2012-2013

    10 February, 2015 Ken Christie COO, VTS Consultants, Inc.

    If there is one word within the life science industries that causes concern and anguish it is “audit.” As with any evaluation process, the success of getting through a regulatory audit is a combination of preparedness with regards to what to expect, knowing the current regulations that apply to your product and knowing what tends to be the areas of deficiencies in audits performed. All of these items can be researched on the web and the time and effort to review and provide training on them will serve companies well.

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  • CAPA Should Not Be a Dreaded Four-Letter Word

    5 February, 2015 Cindy Fazzi, Editor, MasterControl Insider

    In a regulated environment, CAPA is a requirement for addressing and mitigating deviations and nonconformances. A quick review of FDA warning letters indicates it’s a dreaded four-letter word for many companies cited for violations.

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