Source: https://www.mastercontrol.com/gxp-lifeline/for_medical_device/
Timestamp: 2019-05-26 23:16:59
Document Index: 95326538

Matched Legal Cases: ['art 820', '§ 803', 'art 11', 'art 11', 'art 11', 'art 2', 'art 1', 'art 820', 'art 1', 'art 11', 'art 11']

Finding Ways to Cope with new Medical Device Tax - Medical device companies started paying a 2.3 percent excise tax this past January as part of the Affordable Care Act, also known as "Obamacare." The industry has opposed the tax, which is being assessed on total revenues, not profits. The Obama administration has said the excise tax will be offset by an increased number of insured people receiving treatments; it's something that remains to be seen.
Transitioning from an FMEA Risk Analysis to a Total Risk Management System - Traditionally companies have been performing risk analysis to identify hazards, categorize the risk, and find methods for mitigating those risks. This approach has only been focused on the finished product with a limited view during design controls, not on how product is actually used. The risk analysis has been done as part of design and development with the development team themselves identifying the risks and hazards. What we are seeing over the last few years is that risk analysis or risk assessment is just a part of the entire picture. Organizations are realizing that a total risk management system must be implemented for their quality system to gain the full advantage. This article will discuss how companies can integrate risk management philosophies and techniques into their quality system processes.
Developing a QMS: Should You Buy or Build? - When it comes to a quality management system, should you buy or build? Many regulated companies face this dilemma. Perhaps these companies are small startups without a QMS, or maybe they are established but they want to improve their existing systems.
An Engineer Takes on the Medical Device Regulatory Process, Part I - Medical device companies have one primary goal: to develop, manufacture and market a medical device that addresses an unmet market need. While itâ€™s a common goal, the medical device regulatory approval process can be confusing for design and development engineers. They may hear terms such as "safety agency," "CE mark," "Notified body," "510K" and "PMA" tossed around by quality and regulatory professionals. Although these terms are likely to be somewhat familiar, their true meanings and proper application are not always clear to many of us who are part of the development process.
Six Costly Mistakes that Start-Up CEOs Should Avoid When Launching Medical Devices in Europe - Representing one-third of the global medical device market, the European Union provides a significant opportunity for start-up medical device companies. But, it can also present costly challenges for the unprepared. Following are a half-dozen cautions drawn from real-world experience that could help you avoid the most common commercial pitfalls.
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 device companies, while the impact of others is less apparent. We discuss certain key FDASIA provisions below.
Why You Need to Go Beyond Risk Analysis and Apply Total Risk Management - Complying with regulation so that device makers avoid being slapped on the wrist by the U.S. Food and Drug Administration is a narrow effort compared with building high-quality devices that meet the needs of patients.That's the distinction that Steve Silverman, FDA's top compliance officer when it comes to devices, made at a speech to a Minneapolis audience on Monday night.
Why You Need to Go Beyond Risk Analysis and Apply Total Risk Management - Traditionally companies have been performing risk analysis to identify hazards, categorize the risk, and find methods for mitigating those risks. This approach has only been focused on the finished product with a limited view during design controls, not on how product is actually used. The risk analysis has been done as part of design and development with the development team itself identifying the risks and hazards. What we are seeing over the last few years is that risk analysis or risk assessment is just a part of the entire picture. Organizations are realizing that a total risk management system must be implemented for their quality system to gain the full advantage. This article will discuss how companies can integrate risk management philosophies and techniques into their quality system processes.
Quality Audit: A Tool for Continuous Improvement and Compliance - The word "audit," in the broadest sense, refers to a variety of activities. It may refer to an accounting firm examining the financial statements of a public corporation, or a consultant checking the process of lid sealant dispensing in a semiconductor package assembly line. It may even refer to a mystery shopper testing the patience of sales clerks in an upscale department store.
Single Sourcing of Critical Components: Strategies for Optimization - The increase in virtualized or under-resourced biomedical companies has resulted in a dramatic shift in outsourcing components and supplies. Larger companies are also joining this outsourcing trend. Even more profound is the development of reliance on single sourced suppliers, particularly for critical components. While this can be an effective way to improve cost of goods and efficiencies, there are some significant risks associated with this practice. This paper examines these risks and addresses strategies to dispatching or mitigation these concerns.
Contract Management: What's Compliance Got to Do with it? - 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.
Regulations Vary Worldwide but Risk Management is Common Denominator - GxP professionals understand the need for quality and quality system and we discuss quality with one another on a daily basis. But how do we measure it? How do we quantify our results? Once again we turn to Len Grunbaum and Emma Barsky, regular contributors to GxP Perspectives, for their insight on how to quantify quality for the development manufacture, and distribution of health products such as drugs, medical devices, and biologics.
Quantifying Quality for GxP Compliance - GxP professionals understand the need for quality and quality system and we discuss quality with one another on a daily basis. But how do we measure it? How do we quantify our results? Once again we turn to Len Grunbaum and Emma Barsky, regular contributors to GxP Perspectives, for their insight on how to quantify quality for the development manufacture, and distribution of health products such as drugs, medical devices, and biologics.
When Good Teams Go Wrong - So, what makes good teams go wrong? It's rarely a lack of technical skills. Many good teams have all the experience and technical knowhow they need. But they tend to miss or ignore signals that suggest the rudimentary, essential elements of teamwork are absent on their team--and they are unable or unwilling to recognize how this dysfunction sabotages their efforts.
Implementing a New System: Why Training Reinforcement is Critical - It all sounds familiar: You attend a training course that you are excited about. You spend two or more days soaking up new information. You take notes diligently. Before you know it, the training is over. You go back to the office. And after a while, it happens: The new knowledge fades.
Process Verification vs. Process Validation - Process validation officially became part of the FDA's Quality Systems Regulation in 1997. Fifteen years later medical device manufacturers still struggle with determining which processes require validation. The confusion traces back to two words, "fully verified." What does "fully verified" mean? What do I do if I determine that process can't be "fully verified?" And, equally important, what are the FDA's expectations when I can't?
Employing Audits for Improved Supplier Performance - According to the FDA, 21 CFR Part 820.50 (Purchasing Controls) continues to be a significant concern, with the agency issuing Form 483 Observations and Warning Letters citing continued violations by device manufacturers. According to Kimberly Trautman, the FDA's current Good Manufacturing Practices (cGMP) and Quality System Regulations (QSR) expert, suppliers providing non-conforming material are directly related to an increase in medical device recalls, which increases the need for effective quality processes to mitigate risk. With the FDA's increased vigilance, how can device manufacturers better position themselves to achieve and sustain compliance? The answer lies in the establishment of an effective purchasing control procedure that places significant emphasis on supplier controls and the establishment of a value-added supplier audit program. A value-added supplier audit program can help organizations mitigate business and regulatory risk while reducing the Cost of Poor Quality (COPQ).
eMDR Conversion and Implementation - Part II - Best practices for submitting eMDRs are similar to those for paper submissions—the more information in the report, the more complete it will be. And for supplements, we recommend following the instructions found in 21 CFR Â§ 803.56(c), which states that supplemental or follow-up reports should "Include only the new, changed, or corrected information in the appropriate portion(s) of the respective form(s) for reports that cross reference previous reports."
Effective Nonconformance Management: Key to FDA and ISO Compliance - A product's quality, reliability, and safety depend to a great extent on its conformance to specifications that have been tested, proven safe, and approved. This is particularly critical in products that have direct impact on public health and safety, such as medicines, medical devices, cars, household appliances, and other consumer goods.
eMDR Conversion and Implementation - Part I - The electronic Medical Device Reporting (eMDR) program allows for the electronic submission of mandatory medical device reports (MDRs), which are regulated under federal law (21 CFR 803). The eMDR program changes how reports are submitted—it does not change what is considered reportable or what information those reports should contain.
Annex 11: The EU's New Expectations for Regulated Computerized Systems - In 2011, the European Union (EU) revised its guidance for the life cycle of computerized systems to reflect the increased use and complexity of automated systems in the pharmaceutical industry. The guidance, called Annex 11, also was revised in response to an alarming number of problems detected in computerized systems.In plain English, Annex 11 wants to ensure the computerized systems you use to manufacture medicinal products have no adverse impact on product quality, product efficacy, or patient safety. In addition, when a computerized system replaces a manual operation, Annex 11 wants to ensure there are no increased risks.
MasterControl Presents 'Change Control--a Risk-Based Approach' at MD&M Texas - MasterControl Inc. will present "Change Control--a Risk-Based Approach" as a workshop at the MD&M Texas 2012 Conference, March 15, 2012, at the Fort Worth Convention Center in Fort Worth, Texas. MasterControl's Kevin Marcus, product manager and medical device expert, and Walt Murray, director of quality and compliance services, will conduct the workshop.
End-to-End Supply Chain Visibility: It's no VUCA-tion for Supply Chain Professionals - In a survey conducted by ChainLink Research, pollsters "found that the vast majority of respondents (nearly 80 percent) do not manage risks beyond their immediate first-tier suppliers. Instead, they rely on their immediate suppliers to manage those risks." With so many well-respected supply chain analysts talking about the importance of developing end-to-end supply chain visibility, 80 percent seems like a big number of non-believers. Perhaps it is the phrase "managing risks" that causes that number to be so high. After all, having supply chain visibility is not exactly the same thing as managing risk. Regardless, I suspect that most supply chain analysts would tell respondents who fall into the 80 percent group that they are being short-sighted. Lora Cecere, for example, believes that companies need to develop "value networks that extend from the customer's customer to the supplier's supplier, and that [they need to] sense, shape and respond by listening, testing and learning with minimal latency."
Annex 11 and 21 CFR Part 11: Comparisons for International Compliance - The two (2) essential resources available to regulated life-science professionals regarding the validation of computer systems are: the United State's Food and Drugs Administration's (US FDA) rule on Electronic Records/Signatures (21 CFR Part 11 a.k.a. Part 11) and the EMEA's Guidelines to Good Manufacturing Practice (GMP) - Annex 11, Computerized Systems (a.k.a. EU Annex 11).
Change Control - Continuous Quality Improvement in FDA and ISO Environments - Globalization of the marketplace has greatly intensified competition. It has increased the pressure on manufacturers to develop innovative, high-quality products faster and at a lower cost. To stay competitive, manufacturers must be quick to meet customer demands and even quicker in adapting to changing market conditions.
What to Expect When They're Inspecting - Part I - The next time you attend an industry function like BIO, BioEast, or an AABB conference, start up a conversation about FDA inspections with those seated at your luncheon table. It's more than likely that everybody will describe a different inspection experience and that no two perceptions will be the same.
Writing and Enforcing Your SOP for GxP Compliance Success - Part 2 - Writing and developing solid operational procedures is a skill that develops over time. Procedures are usually fairly technical and often describe complex subjects. These procedures are reviewed by subject-matter experts, as well as by internal and external auditors and by employees at all levels of the organization. Therefore, it is important to consider the language used when communicating an idea.Terms like "must," "shall," and "will" indicate steps within a procedure that must be adhered to exactly with each execution. Avoid words that cause ambiguity. Words such as "periodically," "generally," "may," "should," and "can" typically indicate a preference and do not enforce consistent execution.
Is There a Legal Requirement to Have SOPs for GCP in Europe? - In Europe, the principles of Good Clinical Practice were adopted in July 1996, and became operational in January 1997. These principles were laid down in the community guideline: Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95), otherwise known as ICH Topic E 6 (R1) Guideline for Good Clinical Practice or ICH GCP. Despite having no uniform legal framework for implementation, ICH GCP was largely adhered to within the European Community (EC) as a set of 13 internationally recognised principles for conducting clinical trials. In turn, these were founded in the bioethical principles established in the Declaration of Helsinki. But, its adoption as a regulatory standard was neither complete nor uniform.
Writing and Enforcing Your SOPs for GxP Compliance Success - Part 1 -This paper addresses the fundamentals of writing and enforcing your SOPs not only for compliance and in accordance with internal company policies and requirements but certainly for ensuring compliance with FDA requirements as well. Typical definitions include the procedures and processes that you utilize and operate under. These procedures and processes have been standardized to ensure they are done the same way every time. A "clearly written description of how specific tasks are to be done." Another satisfactory definition would be "detailed written instructions that achieve the uniformity of the performance of a specific function."
How to Build a Business Case for a Quality Management System - It is impossible for FDA regulated manufacturers to conduct business without paying close attention to regulatory compliance. FDA regulations can introduce increasing complexity into internal business processes, delaying the pace of innovation and new product introduction. Also, complying with regulations is expensive, with the cost of compliance now estimated at two percent of revenues. This expense, however, pales in comparison to the potential costs and risks associated with non-compliance.
The Use of "Poka Yoke" with Medical Device Design and Manufacturing - In 1961, a Japanese Manufacturing Engineer named Shigeo Shingo working at Masushita Electric developed the idea into a formal tool for achieving zero defects and eventually eliminating quality control inspections. The term "poka-yoke" generally translates as "mistake proofing" or as "to avoid inadvertent errors."
Management Review: Measuring the "Heartbeat" of Your Quality Management System - Management Review is sometimes viewed with some ambiguity because there are so many different ways to conduct these planned sessions. Most of the approaches taken by medical device companies to organizing these reviews are (just) compliant and even go so far as to fulfill only the very basic requirements of the required Regulations (21 CFR, Part 820) and Standards (e.g. ISO 13485:2003 and ISO 9001:2000). Being compliant and fulfilling perceived needs is not enough, however. Management Review is commonly driven by the use of various quality tools depending upon the caliber of deliverables that are expected and the sophistication of your planned metrics. The following article is not a primer for management review but does contain information regarding experiential outputs and top-level guidance derived from practical approaches toward process orientation and communication techniques. This sometimes indescribable information relates to those subtle demands that combine your company's Quality Management System (QMS) with business goals and objectives. You'll find that management reviews commonly have your company's unique "signature" embroidered on the agenda.
Developing a Supplier Scorecard: Devising Aspects of Supplier Performance - Organizations have attempted to measure supplier performance in a number of ways as a part of their quality management program, based on customer requests, or as part of the effort to manage supply chain risk. Supplier measurement systems have been in place since the mid 1970s with varying degrees of success, both in the product and service industries. Typically, suppliers are provided measures and targets as performance indicators, data is collected on performance and published, and the buyer works with the suppliers to evaluate shortfalls in performance and to develop corrective actions. In some rare cases, the supplier receives incentives and rewards such as being able to provide additional products or services or being designed into future products or services by the buyer. The Balanced Scorecard method has created a significant level of interest and compliance in determining how a specific organization is performing and a supplier measurement system is the underlying way to measure supply chain performance.
FDA Announces 510(k) Changes - The Food & Drug Administration announced that it plans to make 25 changes to its 510(k) medical device clearance program this year, but will hold off on any major moves until after the release of an Institute of Medicine report scheduled for the summer.
Supply Chain Oversight is the FDA's Next Area of Concern - The FDA recently stated its intent to stretch its enforcement reach over foreign device suppliers through consent decrees. The FDA also asked manufacturers and importers to take bigger steps toward managing suppliers and tightening up the supply chain. Carmelo Rosa, an FDA compliance officer, explains that "Currently, the agency only has authority to establish import alerts for foreign companies with good manufacturing practice violations but it is looking at other options."
Four Common Quality Misconceptions - For over a decade now, I've had the distinct pleasure of talking quality with professionals representing a myriad of industries. For the most part, people who reach me are experiencing a quality related issue and are looking to quickly extinguish the fire and prevent recurrences. Or they may simply want to reduce their overall risks--and costs--by incorporating a specific quality initiative.
Proposed Changes to the 510(k) Process: 10 Recommendations for Strengthening the 510(k) Program - Recently released recommendations for changes to the Food and Drug Administration's (FDA) 510(k) clearance program for class II medical devices has been a hot topic within the medical device industry. The 510(k) notification process uses predicate devices that the Center for Devices and Radiological Health (CDRH) at FDA has previously cleared for market release through the 510(k) notification process. New devices submitted for clearance must show substantial equivalence to predicate (cleared) devices. Unlike the more restrictive premarket approval (PMA) process where the manufacturer must demonstrate reasonable safety and effectiveness (most often in combination with human clinical research trials) CDRH reviews documentation submitted as a 510(k) and determines if the device is substantially equivalent to a predicate deviceâ€”and thusâ€”cleared for market release. Of the roughly 4,000 510(k) submissions CDRH receives each year, it clears about 3,000 devices from some 1,500 firms.
Med-tech Firms Face a Changing Economic, Regulatory Landscape - The good news for medical technology companies is that they fared pretty well in the past year, despite harsh economic pressures.The bad news? The long-standing business model for developing new medical devices is under siege, according to an industry study released this week by Ernst & Young.First, the data: Revenue of U.S. publicly traded med-tech companies was essentially flat last year at $198 billion -- compared with $200 billion in 2008. The "slight year-over-year contraction" comes on the heels of 11 percent growth in 2008 and is the first time the U.S. industry has experienced a revenue decline since 2004, according to the report.
Assessing the Proposed Changes to the US FDA's 510(k) Program - The paradigm applied for providing reasonable assurance that every medical device marketed in the US is safe and effective is the most stringent in the world. In accordance with current applicable law, regulations, guidance and policy, these critical healthcare products are required to be designed, tested, manufactured, cleared and marketed in compliance with a detailed series of rigorous requirements and standards. The 510(k) process has nonetheless come under criticism in recent years, with some constituencies (including the FDA) proposing fundamental changes to the regulatory paradigm.
ISO 9001: Quality Objectives and Quality Dreams - This article reviews common practices for, and the positive results of, establishing measurable quality objectives for ISO 9001 and other quality management systems. The author suggests a practical model for identifying and documenting objectives to drive the continual improvement of management systems. This article also illustrates ineffectiveness that results from vague and poorly defined quality objectives, and demonstrates how well-structured and documented quality objectives can lead an organization to a more efficient quality management system that increases customer satisfaction. An example of a Quality Objectives Matrix (shown in the paper) presents a useful method for documenting and managing various aspects of quality management systems. The paper will be helpful to those organizations that have not yet formally documented their quality objectives and for those that are interested in improving the effectiveness of their quality management systems and the performance of their businesses.
Defining GxP Training/Learning: Part 1 - The bio/pharmaceutical industry has created its own language and GxP is one of many acronyms that we all tend to use. While this may seem "elementary" to some of you, many people may not know what this means. So let's define it because when we refer to "GxP training" you need to have the right context.
Failure Investigation: Treating the Root Cause, Not Symptoms - Why should medical device manufacturers perform failure investigations? One reason is that it is a regulatory requirement; the Code of Federal Regulations (21 CFR 820) in areas such as Non-Conforming Product, Corrective and Preventive Action and Complaint Files describes the requirements for failure investigations. It is also good business practice which can lead to reduction in scrap and rework, process improvements and the elimination of recurring issues. However, the most significant reason is that customers, i.e. the patients, expect safe, reliable and effective products which will perform as intended.
The Medical Device Design History File, Technical File / Design - The United States Food and Drug Administration recognizes that with devices, the majority of serious problems are introduced during the design / change phases of development of new or changed products. Changes to existing products are addressed under Change Control, Engineering Change Orders, and similar required cGMP procedures. In the mid 1990s, it was recognized that the design of new product or major changes / line extensions to existing products was not well controlled. Recognizing this issue led to a solution: Design Control.
Validation of Off-the-Shelf Software - While there is extensive guidance and documentation available for the development and validation of proprietary software, there is relatively little guidance available for the validation of commercial off-the-shelf software (OTS). The FDA's guidance document for software development, while somewhat dated (2002), provides some general guidance (including reference to general principles of software development) and references to additional guidance documents for software used in production and processes.
Process Validation for Medical Devices - Process validation is an essential part of medical device manufacturing but doesn't always receive the attention it deserves (and requires). The regulations provide the requirements (FDA QSR 820.75 and ISO 13485 7.5.2), but often manufacturers don't completely understand them and don't fully implement them. The consequences can be audit findings from a Notified Body or Inspectional Observations on an FDA 483.
The Four Pillars of QSR Compliance - At first glance, FDA's Quality System Regulations (QSR) for medical devices - contained in 21 CFR 820 - may make your eyes cross and your stomach churn. The rules are intimidating, yes - but impossible to follow, no. Like the old proverb says, the way to eat an elephant is one bite at a time, and the way to comply with the QSR is to break down your quality system into bite-size chunks, which FDA has conveniently labeled "subsystems."
Ten Signs Your CEO Still Has No Idea About ISO 9011 and Lean - It's pretty obvious that in so many companies, based on their actions and behaviors, CEOs and other top managers just don't get ISO 9001 and all the derivative standards. The following 10 signs are written in no particular order. You'll need to be the judge as to which ones are most prevalent within your own organization. How many can you relate to? After reading this article, you may also wish to forward it to someone who should probably read this, like maybe...oh, I don't know...your CEO...or ummmm...some other top executive? Directions for how to do so without getting into trouble are at the end of this article.
The Future is Now for Computer-Based Quality Systems - Especially for users of paper-based quality systems, it's hard to believe that it's been close to 25 years since companies first began using computers to facilitate their regulatory obligations for maintaining quality systems. Throughout this 25-year period, there has been extraordinary progress in technology, features, functionality, and scope of the solutions; along with an equal amount of disappointing results and unrealistic expectations. Many companies over the years have spent small (and some not so small) fortunes on systems that sometimes just didn't work, or if they did, didn't work the way the organization expected them to. The great news for FDA-regulated companies of all sizes is that the future is finally here, and there are now highly-effective, highly configurable, computer-based system options for small, medium and large FDA-regulated manufacturers, with solutions to fit every budget.
Better Innovation for Product Development and Process Improvement - What is a problem-solving method based on logic and data, not intuition? What is a problem-solving method that accelerates, broadens, and deepens a project team's ability to creatively solve difficult, pertinent problems? The answer is TRIZ. TRIZ provides repeatability, predictability, and reliability due to its structure and algorithmic approach. "TRIZ" is the (Russian) acronym for the "Theory of Inventive Problem Solving." G.S. Altshuller and his colleagues in the former U.S.S.R. developed the basic method between 1946 and 1985, and it has been greatly enhanced by international researchers from 1985 to now.
Uncertain Times for Medical Devices - Regulatory and Clinical Advice - Although the economic downturn has put increased pressures on medical device companies to curtail spending and has limited the available sources of venture funding, there are opportunities to continue product development activities while avoiding significant capital expenditures. Given the lengthy approval process for many devices, it is prudent to continue to add value to the technology and demonstrate incremental progress toward premarket review and approval. To that end, there are numerous regulatory and clinical activities that may be undertaken that do not necessarily require large outlays of capital to complete. Even though the U.S. regulatory environment for devices is in midst of potentially significant changes as FDA examines its policies and programs, taking steps to add a degree of clarity to your product development pathway may be helpful in attracting investments for your product.
Overview of ISO 13485 - Medical Device Quality Management System Requirements - ISO 13485 is a regulatory standard whose focus is meeting customer requirements, including regulatory requirements, and maintaining the effectiveness of the QMS. This differs from ISO 9001:2000 which focuses on customer satisfaction and continual improvement. Whereas both customer satisfaction and continual improvement are as important to medical device manufacturers as to any other business today, these are things are hard to measure, and tend to be somewhat subjective. So when it came time to adapt ISO 9001:2000 to the medical device industry, these potentially subjective requirements were changed to meeting customer requirements and maintaining the effectiveness of the QMS, which are more easily measureable.
Beyond the Basics - Building Business Value through an Effective Compliance Program - Through the recent overhaul of the AdvaMed Code of Ethics, medical device companies gained the opportunity to use the renewed emphasis on ethics to revamp their approach to compliance. Most companies quickly integrated the updated Code provisions into their compliance policies and trained their employees to follow explicit guidelines about appropriate and inappropriate interactions and arrangements with healthcare professionals. Now they stand ready to take the next steps to build global compliance programs that create business advantage, foster innovation, and contribute to long-term viability.
Quality By Design, Total Product Life Cycle, and Seven Ways to Improve Design Controls for an FDA Inspection - Quality by Design (QbD) provides a medical technology company with an enhanced understanding of product quality and a strong basis for risk management. With the increased regulatory flexibility that FDA has been showing in the past several years, this facilitates design of products and processes that maximize the product's efficacy and safety profile. Additionally, using QbD may also enhance product manufacturability. The fundamental approach to QbD understands the relationship between the quality attributes of the product and their impact on the safety and efficacy of the device.
Avoiding the CAPA Calamity - When my friend from FDA originally coined the expression "death by CAPA," it was with the best of intentions. Her concern was for those who were killing their respective companies with an overabundance of entries into the CAPA system. These employees were doing so in an effort to ensure all that needed to be examined was always caught. To avoid your own CAPA calamity, let's examine two key distinguishing features of a good approach to CAPA management.
eMDR and Event Problem Code Changes: Are We There Yet? - So where are we with respect to eMDR? At present, there are currently more than 30 device manufacturers submitting electronic MDRs to FDA via the FDA eSubmitter (low volume) option and six device manufacturers submitting MDRs via the HL7 (high volume) option. The regulation that will mandate electronic submission of MDRs is imminent. It is expected that once the regulation is published, device manufacturers will have approximately one year to implement the requirements of electronic reporting of MDRs into their systems. Once the implementation phase is complete, paper copies will no longer be accepted by FDA, so you want to act early to avoid compliance problems in the future.
Writing and Maintaining SOPs: Drudgery or Delight - "SOPs! We don't need no stinking SOPs!" This is how many companies feel when asked about their standard operating procedures (SOPs). They may think they don't need the proper documentation to do a good job. What companies fail to understand is that working without SOPs is becoming increasingly impossible---and even dangerous---in the world of regulated industry.
Can Medical Device Manufacturers Speed Inovation and Lower Costs while Increasing Quality? - Medical device manufacturers have consistently focused on bringing innovative products to market. To achieve this, most companies have implemented sequential design and manufacturing processes to ensure the regulatory compliance and the highest possible quality. But sequential processes have become inadequate and CDRH is advocating the Total Product Life Cycle.
Deadlines or Dead Projects - For all medical device companies managing a project can be a nightmare. Proper planning and managing of a project can make the difference between a successful product and a financial disaster. Most projects start out with good intentions but with improper planning, the project can quickly fall behind and run over budget for a number of reasons: poor documentation, lack of documentation, scope creep, lengthy timelines, ignored timelines, employee commitment, change control and project tracking are among some of the most common experienced in the industry. In this article, we'll take a look at the each one of these examples to see the effects they can have on a project.
"Standard Work" for Problem Solving - When problems occur, are they addressed in a planned, consistent, predictable way? Does a simple problem (i.e. transcription error, typo, missing part) receive the same level of rigor as a complex, multi-variate problem? Are the appropriate problem solving team resources involved and do they all have a consistent expectation of roles & responsibilities? If you're a medical device manufacturer, are investigations and the resulting documentation providing the objective evidence needed to demonstrate compliance?
How They Did It: Pfizer's Transition from 50 Document Management Systems to One - Imagine undergoing an FDA audit requiring a search of 50 document systems for key audit items. This was the situation at Pfizer until recently, when Craig Barilla and his team began combining the company's 50 document management systems into one. Craig and associate Beth Boucher describe the execution of this Herculean task and the results of streamlining Pfizer's document systems.
Current Political Climate Favors Passage of Drug and Device Accountability Act of 2009 - Although essentially the same as its 2008 predecessor, the recently announced Drug and Device Accountability Act of 2009 is much more likely to become law in today's more favorable, "accountability-conscious" political climate. If and when this happens, the bill will subject product applications that contain false or misleading information to stiff fines (up to $5,000,000), and these fines will be assessed both to companies and their senior officers, who, in addition, will face jail sentences of up to 20 years.
Good and Bad Responses to 483s - Preparing a response to a Form FDA 483 can be a time-consuming and stressful process. It diverts resources from other activities and, if not managed properly, the process can be overwhelming. If a 483 response is well written, factually correct and complete, it will establish that the firm has taken or is in the process of taking appropriate corrective and preventive action.
What is the FDA's Third-Party Inspection Program and pMAP? - Many medical device manufacturers do not realize they can save time, money and resources while satisfying inspection requirements by the FDA and other conformity assessment providers. Under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), the FDA introduced the Inspection by Accredited Persons Program or Third Party Inspection Program. Under this program, eligible Class II and III medical device manufacturers can turn to an FDA-accredited third party to perform U.S. regulatory inspections.
Off-Label Promotion of Medical Devices: Seeking Clues from the Past to Protect Against Increased Enforcement in the Future - Pharmaceutical companies that promote their products for off-label use continue to be the subject of intense regulatory scrutiny. But they are no longer alone. Recent statements by government prosecutors suggest an increased focus on the sales and marketing practices of device companies.
Virtualization - Taking Advantage of Part 11 to Save Money - John Avellanet of Cerulean Associates says a collision between technology and regulation will soon be facing FDA-regulated industry. The need to cut corporate expenditures is leading companies to outsource data centers to vendors using computer virtualization. What effect will this have on Part 11 compliance?
GCP Compliance Strategies for 2009 - On September 30, 2008 the FDA website listed 44 warning letters for the Bioresearch Monitoring (Bimo) Program's GCP inspection programs. These include inspections of clinical investigators, sponsors/CROs, and institutional review boards (IRBs). The federal fiscal year ends on September 30 and FDA maintains warning letters on their website for one year*. A review of these warning letters sheds light on three new developments.
Creating and Auditing a Global Quality System - The reason that many firms built their quality systems using 21 CFR 820 is that these requirements are more prescriptive. Additionally, for firms located in the United States, FDA can use a host of regulatory sanctions for noncompliance including criminal prosecution against the company and officials within the company. An FDA inspection is an evaluative process where FDA is looking for to record discrepancies, and, if necessary, take regulatory action. During notified body audits, auditors sometimes see themselves as an aid to the firm to help them achieve compliance.
Managing Outsourcing Operations Reduces Risk - FDA is focused on improving postmarket surveillance to optimize the identification, analysis, and use of postmarket information about medical devices. FDA has not enforced active PS requirements extensively historically, but the agency has signaled that this practice is likely to change. Elaine Tseng outlines what you need to know to remain compliant.
Postmarket Surveillance: Are You Prepared for FDA's New Priority? - FDA is focused on improving postmarket surveillance to optimize the identification, analysis, and use of postmarket information about medical devices. FDA has not enforced active PS requirements extensively historically, but the agency has signaled that this practice is likely to change. Elaine Tseng outlines what you need to know to remain compliant.
What's Wrong? Why Do We Have Repeat Investigations? - Repeat CAPA investigations are arguably one of the largest areas of concern for quality managers today. Despite many firms taking the recommended corrective action, repeat investigations throughout the industry have accounted for as many as 30% of all open investigations- or 1 in every 3. What's going wrong? Why is this happening to so many of us?
The Sentinel Initiative: Will it Finally Result in Postmarket Protection and Premarket Improvement? - In June 2008 FDANews released an article describing CDRH's top priority which according to the article's summary is a "new postmarket initiative." Also according to the summary, postmarket issues "have taken precedence over premarket [issues]" and have garnered "the first-place slot for the center's priorities."1
Global Harmonization Task Force Final Document: Role of Standards in the Assessment of Medical Devices - Q&A discusses the new GHTF final guidance document: Role of Standards in the Assessment of Medical Devices.
Summary of Cambashi and FDANews Research Report - "Risk management takes multiple forms. The most obvious view of risk management involves risk to the patients using the device, but the risk to the business itself is also a critical consideration. In theory, risk management for patient safety should also reduce the overall risk for the company and lead to a higher probability of profits."
Patience is a Virtue for Combination Product Manufacturers - In a very real sense combination product manufacturers are changing the face of life science research and manufacturing. In fact, the near future may paint the combination products sector as the leading life science industry sector, while products like transdermal patches for depression, dental bone grafting material with a growth factor, absorbable collagen sponges with genetically engineered human protein, or a surgical mesh with antibiotic coating may become more common than their "less complete" components.
Top Four Activities to Prepare for ISO 13485 Certification - ISO 13485 certification gives a company a competitive edge and demonstrates a company's aspirations for excellence. This article outlines vital activities that companies can perform to prepare for ISO 13485 certification.
The Medical Device Market in Japan: Worth its Weight in Gold? - It isn't only the need for devices and the ready funding that attracts U.S. device makers to Japan. Japan's medical device expertise also acts as an added enticement. Device makers in Japan have a specialized knowledge that U.S. device makers could learn from and vice versa.
The Keys to European Compliance: An Informative Summary Regarding the European Medical Device Vigilance System Guidelines - The European medical device market continues to expand and many medical device companies are determined to keep pace. The recently revised European Medical Device Vigilance System guidelines are designed to guide medical device companies step-by-step to faster and more effective compliance.
Changes on the Horizon: The FDA's Interactive Review Guidance - For medical device companies the new MDUFMA is likely to result in shorter application cycles and more efficient communication with the FDA.
Two Roads Diverged: Current Issues for the Medical Device Industry - For medical device developers, the future lies between "two roads diverged" as the poet would say, and no less than the Supreme Court will be the deciding turnstile at either avenue.
Overcoming the Top Three Project Management Challenges - Suggestions for handling project management challenges like regulatory constraints, resource limitations, and impediments to timely delivery that are encountered during the development of new medical devices.
Five Steps to Simplifying CAPA Documentation Processes - After a record number of medical device recalls last year, the FDA is urging all device companies to double-check corrective and preventive action systems. Here are five tips that can help your company simplify CAPA documentation.
Making Medical Products Better, Faster, and Cheaper:What FDA's Critical Path Initiative Means for Consumers - Janet Woodcock, M.D., explains the Critical Path, FDA's effort to help modernize the scientific process through which medical products are developed, evaluated, and manufactured.
Postmarket Management Team Restructuring Processes at CDRH - The FDA's Postmarket Transformation Team is well into restructuring the way it handles postmarket medical devices. Don St. Pierre, acting associate director for postmarket transformation, talks about the changes his team is making at CDRH.
FDA Postponing Annual Registration of Medical Device Establishments - FDA is temporarily postponing the annual registration of registered medical device companies. The government agency is planning to make some changes to improve efficiency for everyone involved.
FDA Report Shows Challenges of Post-Market Monitoring of Medical Devices - A recent FDA report lists the challenges of monitoring and assessing the safety of medical devices after theyï¿½ve been sold.
CMS Launches New Competitive Bidding Program for DMEPOS - The Centers for Medicare and Medicaid Services (CMS) recently launched a new competitive bidding program for suppliers of durable medical equipment in order to save money. But the medical device industry expressed concerns that it could limit patient access to medical technology and jeopardize the ability of small manufacturers to make their products.
Three Tips on How to Avoid ï¿½Death by CAPAï¿½ -
It’s been 10 years since the FDA introduced a regulation requiring that medical device manufacturers implement a formal CAPA system. Yet, managing a CAPA system remains a major challenge for many manufacturers. Let’s consider a few things that could help you improve your system.By Ken Peterson
Improving Your Quality Management System: A Step-By-Step Approach - Most medical device companies recognize the importance of an effective and efficient quality management system for regulatory compliance and competitive advantage. Here is a step-by-step approach on how to improve your system.
Four Reasons Why You Should Consider Joining the FDA's STED Pilot Program - Wouldn't it be great to launch a product globally? It certainly makes good business sense. But for medical device firms, it's an unreasonable goal because different countries require different submission formats.
Reducing the Documentation Burden in Design Control - It is not uncommon for a single product to generate hundreds of pages of documentation to demonstrate design control compliance. Let’s discuss how you can reduce your documentation burden.
CAPA: Key Stumbling Block for Device Firms - The news that a company the size of GE OEC Medical Systems has a broken CAPA system is shocking. But it is not altogether unexpected if you consider inspection trends.
Quality Audit: Most Common Pitfall for Medical Device Firms - Quality audit is one of the most common pitfalls for medical device firms during inspections.