For Blood / Biologics

  • 100% Training Complete ≠ 100% Effectively Trained - "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.
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  • Transitioning from an FMEA Risk Analysis to a Total Risk Management System - aditionally 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.
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  • MasterControl Revs Operational Excellence Using Six Sigma - The de facto standard for excellent business operations is Lean Six Sigma. Only five years ago you could not say that. But today, in every industry and every geography, companies have determined that the principles and practices of Lean and Six Sigma are the world-class standard for designing, configuring, improving, and controlling business.
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  • Remote Audit: Out of Sight but Not Out of Mind - In life science and other regulated environments, audit is necessary to comply with regulations and to ensure the quality of products. Regulated companies recognize not only the importance of audit, but the value of frequent audits. However, in these economically challenging times, frequent on-site audits can be costly.
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  • Quality Professionals: How to Increase Your Job Security - The life science industry has not been immune to the global economic downturn, with pharmaceutical companies such as AstraZeneca, Roche, and AMAG Pharmaceuticals recently announcing layoffs. Similarly, medical device companies such as Stryker, Medtronic, and Smith & Nephew have announced job cuts. So, is there such a thing as job security anymore?
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  • Can You Use Automated Testing Tools as an FDA-Regulated Company? - Software test tools help development and testing teams verify functionality, ensure both the reliability and security of the software they develop, and investigate software bugs. Off-the-shelf tools are available for all stages of software development. Examples include static code analyzers, record and replay, regression testing, and bug tracking. Some software testing tool vendors offer an integrated suite that starts with the gathering of requirements and continues through software development and testing throughout the life of a project, including supporting the live system. Other vendors concentrate on a single part of the application development life cycle, such as just testing.
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  • Quantifying Quality for GxP Compliance - GxP professionals understand the need for quality and quality systems 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 insights on how to quantify quality for the development manufacture, and distribution of health products such as drugs, medical devices, and biologics.
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  • Trends in Q1 FDA Warning Letters - If you work in the life science industry, it is always a good habit to periodically check the FDA's website for enforcement actions and warning letters. You can glean important insights from the mistakes and weaknesses of other companies in your industry, maybe even your competitors. You will see what the FDA is emphasizing in inspections, perhaps see some trends.
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  • Surviving the Back Room During an FDA Inspection - During one of my early inspection experiences with the FDA, I found myself working with a team that felt it didn't need a backroom setup to review documents prior to bringing them to the investigator. Naively, I agreed to let the team move forward with the inspection. As the observer, I watched as things spiraled out of control.
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  • When Good Teams Go Wrong - How's your team doing? Are you hitting your targets without leaving "dead bodies" in the wake? Do you sense trust, commitment, and accountability from your fellow team members? If the answer is yes, fantastic—you're in an elite club! But if your team is like many others, sometimes (or more often than not) you feel "dysfunctional." Not quite working on all cylinders... not cooperating or communicating well... not making decisions that stick. Dealing with power struggles that exhaust and frustrate everyone. Running on empty.
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  • FDA Says Part 11 Guidance Remains Status Quo - Time and again, rumors surface about the possible update of the 2003 guidance on the scope and application of 21 CFR Part 11. The never-ending speculation attests to the enduring interest in Part 11, not to mention the continued scrutiny of the regulation.
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  • Quality and Risk Management in Clinical Studies - With all that goes into a clinical trial, from documentation and procedures, to a variety of study support staff, managing risk may often be overlooked or merely addressed in a reactive way. However, in order to increase success in clinical trials, an organization must have an efficient risk management plan and be proactive and not simply reactive. In order to obtain a complete understanding of risk in a clinical trial, a risk assessment must be taken from various perspectives. Also, risk management is more than just assessing the risk; it should include contingency plans for rectifying and preventing risk in order to minimize risk.
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  • What to Expect When They're Inspecting - Part II - The first segment of this series focused on some of the non-traditional variables that can have an effect on any FDA inspection and how to achieve a positive outcome regardless of the inspectional conclusion. That article generated some blog discussion on FDA's objectivity. I wanted to clarify some of those issues. FDA Investigators are trained to be objective in all situations and will approach their inspection in this manner. However, firm management needs to understand that when intentional barriers to an effective inspection are presented or the FDA Investigator is met with a less-than-cooperative attitude, the realistic conclusion is that management is trying to hide objectionable GMP conditions, leaving the Investigator no choice but to be even more thorough to ensure there are no safety or quality risks to the consumer. It isn't that an FDA Investigator is showing bias or being subjective, they're "Investigators" - it's their job to do so.
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  • 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.
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  • Surviving the Back Room During an FDA Inspection - During one of my early inspection experiences with the FDA, I found myself working with a team that felt it didn't need a backroom setup to review documents prior to bringing them to the investigator. Naively, I agreed to let the team move forward with the inspection. As the observer, I watched as things spiraled out of control.
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  • How Life Science Companies Can Leverage Mobile Technology - Mobile technology has come a long way. Smartphones and tablets are getting better, smaller, and less expensive. It is no wonder that almost everyone has one. More and more employees use them not just for personal reasons, but to perform some of their work. In many cases, companies are forced to provide IT support for these employees. Those companies find themselves having to catch up with their employees who are leveraging mobile technology.
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  • Is FDA to Blame for Biomedical Industry's Slow Growth? - Given the global economic challenges today, it is understandable that the biomedical industry sees lack of funding as a key obstacle in growth. What is surprising is that the industry also sees the FDA and the current regulatory environment as a stumbling block.
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  • Is Your Executive Management Team as Involved with the Quality System as They Should Be? - We've all heard of the recent FDA decisions to increase the focus of inspections on management with executive responsibility. There have been at least two warning letters issued this year with observations targeted in this area. While there are 26 references to the role of executive management within the Quality System Regulations (QSR 21 CFR820) these warning letters address two very basic requirements of quality systems.
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  • Annex 11 and 21 CFR Part 11: Comparisons for International Compliance - The two essential resources available to regulated life-science professionals regarding the validation of computer systems are: the Food and Drug Administration's (FDA) rule on Electronic Records/Signatures (21 CFR Part 11 aka Part 11) and the European Medicine Agency's (EMEA) Guidelines to Good Manufacturing Practice (GMPs) - Annex 11, Computerized Systems (aka EU Annex 11).
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  • 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 shortsighted. Enterprise strategist, Lora Cecere, 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."
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  • Reading the FDA Tea Leaves - As the 21st century continues to drive itself forward, it is becoming clear that the US Food and Drug Administration (FDA) is striving to meet modern challenges. Of especial relevance to executives in industries regulated by the FDA is the immediate impact—for the foreseeable future—of the trends shaping agency action. These actions may include the issuance of guidance documents, inspectional strategies and medicinal product approvals/disapprovals. When considering these potential actions, the business executive has a simple question: Will I, my firm, or our products get caught in the crossfires of change without being prepared?
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  • What to Expect When They're Inspecting - Part I - One expects variations in the level of coverage at firms in different program areas, whether it's drugs, devices, biologics, dietary supplements, clinical research, or a food firm, because each industry area is so technically diverse. However, observation methods used by Investigators should be comparable and not diverge significantly. If two firms are manufacturing the same regulated product, and are both undergoing a routine GMP inspection, why does one receive an FDA-483 citation for an observation while the second firm receives no citation although the same observation was made? Is it a lack of continuity between Investigators, or are there other contributing factors?
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  • Is There a Legal Requirement to Have SOPs for GCP in Europe? - Before addressing whether there's a European requirement for Standard Operating Procedures (SOPs) for Good Clinical Practice (GCP), we need to consider whether ICH GCP (i.e. as provided by the International Conference on Harmonisation) remains the international standard following the publication of the Clinical Trials Directive (2001/20/EC) and the GCP Directive (2005/28/EC). Why? Mainly because the Clinical Trials Directive did not explicitly mention ICH GCP, leading to the perennial question of: which GCP should we be following? So here goes my answer, particularly for those of us affected by European legislation, with a wee bit of context to explain it.
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  • 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."
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  • 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. And complying with regulations is expensive, with the cost of compliance now estimated at two percent of revenues. The expense, however, pales in comparison to the potential costs and risks associated with non-compliance.
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  • Certification and Advanced Degrees: Are They Worth It? - The value of certification and/or advanced degrees, such as an MBA, often comes into question in the wake of economic downturns. There are two camps on the issue. On the one side you have those who spent time and money earning these achievements and now may be questioning the value of these achievements in light of job loss or, at least, job insecurity. The other camp consists of those who don't have advanced education and wonder if obtaining it would help their job search efforts or career aspirations.
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  • Quality Inspiration: Six Quotes for You to Consider - I enjoy insightful prose...I enjoy reading it, thinking about it and sharing it with others. I think memorialized words of wisdom from others not only define the originator, but they also contribute to our individualism. A few months ago, I was curious to know more about the words of wisdom that define the quality community. I reached out in the American Society for Quality's LinkedIn Group asking for personal favorites and have since enjoyed reading over 700 posts!
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  • 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 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.
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  • Why Baldrige Works - There's no doubt that the Baldrige Criteria drive excellent performance. Of course, the perennial question for any improvement approach is "What's the return on my investment?" Cargill, a $107 billion company that produces and markets food, agricultural, financial and industrial products and services, says Baldrige is a huge return on investment. Their divisions that use the Criteria achieve 130 percent of their earnings targets versus divisions not using the Criteria, who achieve about 82 percent of target.
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  • Minimizing the Risk of Donor Disease Transmission - Each year in the United States, nearly 30,000 people receive the opportunity to save, extend or enhance their lives through the human gift of organ donation. Of those, roughly three-fourths of the organs transplanted come from deceased donors. Because every transplant involves a human donor, there is always a small risk of transmitting a disease present in the donor that might harm the recipient. Some potentially transmissible diseases, such as hepatitis or CMV, can be readily identified by a common lab test. Other diseases can't be positively determined in the short time frame that deceased donor organs must be recovered, transported and transplanted. Still other diseases have no specific screening test and may not become known unless symptoms occur in a recipient.
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  • Seven Signs that Your Quality Program is in Trouble - There is no substitute for a powerful "tone at the top" but recent corporate crises have shown that tone by itself is not enough to support quality. Companies widely considered to be the quality leaders in their fields have been battered by quality problems, in part because of a disconnect between the company's message to the public and to its own employees. Toyota has become an iconic example of this "message disconnect." According to industry experts, Toyota's leadership set a blistering production pace at the same time it systematically slashed operating costs. Despite the public statements of leaders reiterating the company's legendary commitment to quality, Toyota's policies sent a very different and clear message to employees and suppliers: quantity and cost trump quality. The consequences of that unspoken message were played out this year through massive recalls and investigations by national enforcement agencies across the globe.
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  • 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.Every situation is unique, so it's important to be as knowledgeable as possible regarding the company I'm working with and their respective industry. Whether it's a small business owner, a QA Manager, or a CEO of a large corporation, these initial conversations allow me to customize an action plan that will address the client's needs and concerns.
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  • 19 Key Elements to Review for Effective Audits - Regulated organizations on a global scale have instituted ways of qualifying suppliers to ensure that their capabilities have been verified. The types of qualification methods used are multifold. Some include quality and business system components that are essential for effective production or service rendering. Others may simply focus on quality characteristics, and still others may only consider production and equipment capabilities. More effective methods, however, include a combination of business, production, service, and quality factors to provide a holistic impression of the supplier's organization. These factors play a critical role in providing excellent customer service.
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  • Transforming Training into Learning: The Importance of a Comprehensive GxP Learning Program: Part 2 - Sponsor organizations have traditionally relied upon a "Read and Understood" approach for instructing its workforce on procedural documents (e.g. Policies, SOPs, working instructions). While this may be a reasonable approach for certain procedures, this method can be unreliable. Reading procedures alone, without additional context and details, may leave an organization vulnerable. Employees need to fully understand their job roles and responsibilities in context; they also need to understand the regulations that keep the organization compliant.
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  • ISO Standards: Quality Objectives and Quality Dreams - Through my consulting and auditing career I have been collecting "the best and the worst" samples of management systems and QMS documentation. Among those collectibles, here are a few examples of the worst-documented quality objectives that I have seen thus far.
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  • 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.
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  • Tissue Tracking Failures and Lessons Learned - Hope for the Future - Allograft tissue tracking failures by health care facilities have occurred when tissue banks have issued recalls. In recent years, the expansion of the Joint Commission’s standards for handling tissue, now located in the Transplant Safety Chapter, is helping to close this gap for facilities under their oversight umbrella but it is ultimately up to each facility to comply with Elements of Performance related to complete tracking. Tissue tracking abilities of free-standing, private facilities, such as a number of outpatient surgery centers and physicians’ offices, remains suspect because no regulatory authority requires them to follow tracking protocols for tissue grafts. Tissue banks have historically offered all end users a way to track to tissue recipients by issuing implant cards/forms with each distributed graft, but the final step of completion and return has experienced only fair compliance. In modern times, what else can be done to close this gap in allograft recipient patient safety? Use of universal machine-readable labels on allograft tissues is a future possibility but may only occur if this desire is real and expectations are voiced appropriately and effectively.
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  • Stop the Madness! Process Control for Continual Improvement - It is a dark and stormy night. Your facility is readying for what promises to be a challenging third-party review. You, the Quality Manager, along with your organization's General Manager, are reviewing a variety of the process monitoring data reports to prepare for the upcoming "grilling." One such report provides information regarding response times to the central monitoring alarm system, specifically for the reagent storage refrigerator..
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  • Nonconformance Management: Key to FDA and ISO 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. In this article, we'll systematically take a closer look at some things (e.g, financial statements, a factory process or even customer service) and discuss the results for purposes of evaluation and—ultimately—decision making.
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  • Quality Basics Simplify Complex Engineering Document Management Challenge - In the spring of 2006, Ray Wilson, an internal business systems analyst for an investor-owned utility company, faced a monumental challenge: how to go about transferring the management of approximately 750,000 documents on paper, Mylar, microfiche, and other media from more than 150 different facilities to one centralized location. Although the scope may have been once-in-a-lifetime, at the heart of the task was a common problem for engineers everywhere-content management for engineering drawings.
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  • Quality Risk Management Approach to ISBT Validation - According to the ISBT-Guidelines For Validation of Automated Systems in Blood Establishments (Guidelines) the blood bank is responsible for the regulatory compliance of the automated/computerized systems used at the Facility and MUST have a Quality Management System (QMS). Blood Banking organizations around the world support these guidelines, which prescribe that full validation of the computerized system be required for systems critical to product and quality (information management, storage, tools for operational decision-making, and control).
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  • Six New FDA Enforcement Policies: How They Impact You - On August 6, 2009, FDA Commissioner Dr. Margaret Hamburg publicly announced the FDA's new enforcement strategy. This strategy involves six new policies that went into effect on September 15, 2009. What are the policies and what do they mean to you? The best line of defense is to have excellent quality oversight now to ensure that the systems in place are compliant, functional, and effective. Then your firm won't have to worry about getting a warning letter in the first place. Easier said than done but more critical now than ever.
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  • Computer System Validation: FDA Inspections - Is your organization ready for an inspection of your Computer System Validation program? In this article, I will offer some key tips on how to prepare for an inspection of your computer system validation (CSV) program. Often times, the FDA comes to inspect your facility for reasons other than your CSV program. However, because so many of our business processes are governed by electronic systems, the topic of Computer System Validation inevitably comes up during the course of an inspection. As a result of an increase in federal investigators, investigators are able to inspect more facilities and dig deeper into areas such as Computer System Validation.
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  • Validation of Off-the-Shelf Software - While there is extensive guidance and documentation available for development and validation of proprietary software, there is relatively little guidance available on 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.
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  • How Auditing Supports Supply Chain Management - One of the fundamental rules of auditing is to measure and evaluate against requirements. While requirements come from multiple sources in an internal and registration audit, for supplier audits these requirements always come from the contract. (Contracts come in a number of different forms, such as purchase orders, letter agreements, etc.) Three things need to be considered, when writing a supplier contract: technical requirements, accept-reject criteria and/or management system requirements.
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  • 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. In this article, let's systematically take a closer look at some things (e.g, financial statements, a factory process or even customer service) and discuss the results for purposes of evaluation and--ultimately--decision making.
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  • Designing a Learning and Performance Program in Tissue and Organ Banking - Keeping up with training management and additional changes in tissue and organ bank environments is an ongoing process. After all, we who work in these environments know what works well and what doesn't. We know for example that with a field-based staff, classroom training is difficult to pull off. Coordinating with everyone's schedules and working around a case load makes training complex! What we have found is that online learning or on-demand learning does work. It allows all of the staff to access training when and where they need it.
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  • 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.
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  • Automating Training Control Processes to Comply with FDA and ISO Requirements - FDA regulatory requirements and ISO quality standards mandate companies to execute and document employee training. (21 CFR 211.25 and 820.25) These requirements ensure employees understand how to perform their duties within company and industry guidelines. Well-managed training programs minimize the risk of non-compliance and improve product quality. This paper identifies the basis for the requirement and examines the associated challenges for meeting the requirement and the shortcomings that lead to general system failures. A new approach for meeting and going beyond the tracking requirements is presented..
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  • 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.
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  • The Challenges of Change Control - The term "change" is something that we all experience both in life and in our business. While some of us might embrace it and seek the challenges, there are more often those that do not like it and are resistant to the implications that change may have. The big difference between the two attitudes is that in life, we face the change, accept it and move on. We do not formalize the event by a series of documents, reviews, evaluations and approvals. In regulated industries, such as pharmaceuticals, biotechnology, and medical devices, the opposite is required and therein are the challenges.
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  • Automating Document Control Processes to Comply with FDA and ISO Requirements - ISO and FDA Current Good Manufacturing Practices (CGMPs) presume that both the process and documentation that directs company processes follows pre-approved methods and that any change to these methods is restricted to authorized personnel and tracked for future review. All FDA-regulated and ISO-certified companies are mandated to have a document change control system. Today's quality management systems provide integrated solutions to handle everything from corrective /preventive actions (CAPA) through change control and training. This article will focus on document control processes within the quality system lifecycle and provide insight into the capabilities needed to automate change control processes that will increase efficiency, ensure compliance with FDA requirements and improve overall profitability.
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  • Data and Content Migrations: Minimizing the Risk - 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 understood. In this context, risks associated with data migrations are a direct result of migration error. Further, industry testing strategies to mitigate such risk, or more specifically data migration error, lack consistency and are far from deterministic. This is the first of two articles that present some thoughts and recommendations on how such a testing strategy can be designed.
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  • The Changing Face of Biobanks - Biobanking is changing rapidly, and it's in no small part due to the demands of systems biology. While small, university-centered banks have existed for decades, large-scale biobanks - whether tissue repositories or population databases - have recently been implemented all across the world. Many are also adding clinical annotation, genetic data, and increasingly genomic, proteomic, and other 'omics information. Population-wide biobanks exist in Iceland, the UK, Sweden, Canada, Estonia, Latvia, Singapore, and Japan. The UK Biobank is one of the most ambitious of these projects, intending to collect, store, and study the genetic information of 500,000 people with the hope of finding correlations between disease and lifestyle, environment, and genes. In the US, the Utah Population Database is the largest of these types of biobanks, housing data from generations of families for more than 8 million people.
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  • The 5 "W"s of Quality Agreements - Items to address in a Quality Agreement include all aspects of a project that affect the identity, quality, safety, potency, and purity of a product. Additionally, include aspects that may affect the compliance status of either the Contractor or Client. One of the most overlooked sections is the Definitions section - it is critical that everyone knows what is meant by every term used in the Quality Agreement; especially when contracting with non-U.S. parties, terminology can vary widely. Include abbreviations and acronyms, and define documents - one person's batch record is another person's data sheet. Define "subcontracting," and if/when it is acceptable. Also, what NOT to exclude from a Quality Agreement is also worth mentioning.
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  • FDA Chooses MasterControl's QMS - MasterControl, a global provider of quality management systems (QMS), is pleased to announce that it has been selected as the QMS software provider for The Food and Drug Administration (FDA). More specifically, The Office of Regulatory Affairs (ORA) within the FDA has contracted with MasterControl through its partner, i4DM. The mission of the Office of Regulatory Affairs is to protect consumers and enhance public health by maximizing compliance of FDA regulated products and minimizing risk associated with those products. ORA's plans to implement MasterControl as its QMS solution throughout all of its various divisions and offices. ORA's field auditors are among those slated to use MasterControl's QMS Software.
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  • Biologic-Device Combination Products: Jurisdiction - 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 (FDA) has dealt with these products for some time and has developed a reasonable approach to regulating combination products. This article will focus on the FDA approach to jurisdiction of cell and device combination products.
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  • The Changing Face of Biobanks - Biobanking is changing rapidly, and it's in no small part due to the demands of systems biology. While small, university-centered banks have existed for decades, large-scale biobanks - whether tissue repositories or population databases - have recently been implemented all across the world. Many are also adding clinical annotation, genetic data, and increasingly genomic, proteomic, and other 'omics information. Population-wide biobanks exist in Iceland, the UK, Sweden, Canada, Estonia, Latvia, Singapore, and Japan. The UK Biobank is one of the most ambitious of these projects, intending to collect, store, and study the genetic information of 500,000 people with the hope of finding correlations between disease and lifestyle, environment, and genes. In the US, the Utah Population Database is the largest of these types of biobanks, housing data from generations of families for more than 8 million people.
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  • Please Don't Call Them CAPAs - I've long been troubled by the ubiquitous acronym used to refer to corrective action: CAPA. My gut reaction borders on the irrational. Most of you reading this have heard of or read about or used the acronym hundreds of times. And you're probably wondering why the two syllables CA-PA should produce such an extreme reaction - especially in someone who spends a great deal of her time teaching people about both corrective action and preventive action. The short answer is simple: They're two separate processes that have been mashed together resulting in a diminution in the effectiveness of both.
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  • Avoiding the CAPA Calamity - Anyone working in quality management is familiar with references to “Death by CAPA” or “CAPA Kills.” CAPA problems are often caused by employees who have the best intentions but end up killing their companies with an overabundance of CAPA entries. How can you avoid your own CAPA calamity?
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  • Increasing Efficiency Through Lean Principles - Lean Manufacturing is an operational strategy oriented toward achieving the shortest possible cycle time by eliminating waste. It is derived from the Toyota Production System and its key is to increase the value-added work by eliminating waste and reducing incidental work.
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  • Writing and Maintaining SOPs: Drudgery or Delight? - SOPs are needed in regulated industries to give step-by-step instructions for performing a particular job or task. The subject matter of a SOP may range from how to operate a piece of machinery to how to log into a particular software program. SOPs ensure consistency and reliability because they require training of all affected parties. While this ensures compliance with internal processes it also helps ensure compliance with regulating bodies, such as the FDA.
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  • Cells and Tissue Traceability and ISBT 128 - Imagine being in a war zone hospital with hundreds of soldiers streaming in with wounds ranging from minor to catastrophic. Blood and tissue transfusions are necessary but the labels aren't standardized; medical staff members are confused. The danger of providing the wrong product to a patient is very real.
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  • Legal Risks Affecting Blood Banks - Blood establishments should make CGMP compliance a top priority because the risks associated with systemic or persistent non-compliance are significant. FDA has an array of options: the agency can subject an establishment to repeated inspections, issue warning letters, seize product and sue for injunctive relief. If an establishment's compliance problems are particularly egregious, there is also the risk of criminal liability.
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  • Designing a Winning CAPA System - Various sub-system elements of a Quality System (QS), business and manufacturing processes produce non-conformances. All relevant QS sub-systems must be designed to identify and correct their non-conformances. These QS sub-systems are also expected to operate within a state of "control." These QS sub-systems are unique and separate entities from the CAPA System, which is also a QS sub-system. There is, however, a hierarchical relationship between these QS sub-systems. QS sub-systems that produce non-conformances must have the ability to analyze and appropriately escalate non-conformances that are identified as either "high risk" or are the result of "out of control" process conditions.
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  • The Value of Performing a Good Validation in Transfusion Medicine - 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 critical systems is a must before any validation is contemplated.
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  • AABB Abstract Submission: Everything You Wanted to Know but Didn't Ask - The AABB Annual Meeting and TXPO, slated for October 24 - 27 in New Orleans, hosts many educational activities. Among these is the Abstract Poster session, an opportunity to share your research with others and possibly obtain preliminary publication for grant and funding purposes.
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  • Retraining Employees: When Once is Not Enough - Most supervisors would agree that their staff wants to do a good job and that their employees do their best to meet the demands of the highly regulated blood bank industry. But occasionally management has to deal with employee performance that falls short of expectations. This issue becomes increasingly important if the employee has committed an error more than once, in spite of attempts to correct the problem.
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  • Blood Bank ISBT 128 Implementation: A View from the Trenches - My own blood bank's ISBT implementation was not quick or easy. If I could do everything again, I would do things quite differently. Hopefully a review of my own mishaps will help you plan your own ISBT implementation more effectively.
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  • A Myriad of Documents - Is there Control? - Document control is an issue for every laboratory. Document control is more than generating good documents; it is the ability to compile, review and evaluate documents that are required to ensure the quality of products and services provided. But how?
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  • Conferees Seek Paths to Improving Blood Center IT Systems - Blood community professionals and vendors met with officials from the Food and Drug Administration in a first-of-its-kind conference examining the impact of federal regulations on the development of donor and transfusion information technology (IT) systems. The conference, which was originally budgeted for about 60 attendees, drew 170 registrants and a great deal of interest in the impact of federal regulation on the development of donor and transfusion information technology (IT) systems.
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  • U.S. Biovigilance Network: Hemovigilance System - The U.S. Biovigilance Network, the nation's first and only nationwide data collection program for the transfusion and biological therapy communities, is preparing for a January 2009 launch of its pilot. The Network has raised more than $1 million in private donations and has also secured support from hospitals and blood centers across the country. AABB's Director of Data and Special Programs describes why the system is vital to the safety of our nation's blood supply.
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  • Health Canada's Progress in Regulating Subsequent Entry Biologics: Draft Guidance Issued in March - With Health Canada's recent publication of its draft guidance entitled, "Information and Submission Requirements for Subsequent Entry Biologics (SEBs)," the agency has initiated its plan to introduce a comprehensive regulatory, legal and scientific framework to approve biologic products that are similar to already approved biologics upon patent expiration.
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  • Writing and Enforcing Effective SOPs - There is no document more critical to a health care company's compliance and business success than standard operating procedures (SOPs). SOPs define how an employee performs a process or even her own job. Failure to have well-written and clearly defined SOPs is a compliance risk and a business risk. Yet many companies chance a regulatory rumble because they fail to write accurate SOPs.
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  • Choosing the Right Tool for Quality Improvement - The most important question to ask when selecting a quality improvement tool is, "What am I trying to do?" "What is my purpose?" There are five fundamental purposes of an improvement team effort--break down, link together, build up, compare and innovate. For each purpose there are one or two basic tools that make those tasks simple.
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  • Blood Substitute's Effectiveness and Safety Addressed In Large Clinical Trial - A predicted shortfall of over 4 million units of blood worldwide is driving the need to develop an alternative to red blood cells. Published in the June edition of the Journal of Trauma®, this study is the first Phase III trial to compare a blood substitute to regular blood and was conducted at 46 sites in the United States, Europe and South Africa.
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  • The Buzz on West Nile Virus - Summer's onset brings that familiar buzz of the bug we all love to hate: the mosquito. The itch, the swelling, the unsightly bumps on the skin---not to mention the scratching---are the annoying price we pay for outdoor fun.
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  • Tracking Blood Electronically - Blood centers have been using reliable and easy-to-scan barcodes to positively identify and track blood products for decades. Radio Frequency Identification (RFID) technology has been widely used other industries with myriad applications for years. The BloodCenter of Wisconsin in Milwaukee is leading an effort that sets the stage to introduce radio frequency identification (RFID) throughout the complete blood supply chain from donation to patient transfusion.
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  • San Antonio Hospital Aims to Perform "Bloodless" Surgeries - 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.
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  • Tissue Banking: Regulations, Operations and Medical Oversight - Human tissues have been used for transplantation and reconstruction for years. But in many ways, quality systems in good tissue practice (GTP) have only recently been applied. Federal regulations exist but don’t extend into the clinical arena. Medical oversight and compliance with voluntary standards are important to enhance and continue the quality elements in hospital that use tissues for transplantation.
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  • Blood Banks Move into the 21st Century with Automation - Technology is moving to the next level in hospital laboratories and blood banks. With the current shortage of qualified medical technologists, hospitals are introducing instrumentation and automation techniques into the blood bank.
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  • AABB Soliciting Public Comments - The AABB is soliciting public comments from the industry on the proposed 1st edition of Standards for Molecular Testing Laboratories.
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  • Sizing Up Staff Competency - Training entry level employees to become competent in a laboratory or technical environment is expensive and time-consuming. Is there a way to assess how much they learned during training?
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  • FDA, Blood Community Representatives Meet to Discuss Priorities - FDA and blood community representatives recently met to discuss topics of mutual concern in the areas of donor and patient safety. FDA guidance documents, pandemic planning activities, activities related to TRALI, biovigilance, availability of tests for donor screening, and implementation of ISBT 128 were discussed.
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  • Preparing for Assessment by the European Union (EU) - The U.S. is a major supplier of plasma products; it provides 60 percent of the world’s needs for plasma, both recovered and source. As a major player in the European plasma market, U.S. blood centers must undergo assessment by the European Union (EU). How should a U.S. blood center prepare for a European inspection?
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  • Making the Blood Supply Safe also Makes it Expensive - A clean and safe blood supply is vital to the health of our country. Blood banks and transfusion centers are beginning to use electronic document systems to keep this vital fluid clean and safe for use.
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  • Electronic Document Systems Becoming Integral to Quality Systems for Blood Banks and Transfusion Centers - A clean and safe blood supply is vital to the health of our country. Blood banks and transfusion centers are beginning to use electronic document systems to keep this vital fluid clean and safe for use.
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  • HCT/P Inspections: Most Common Deviations - The FDA issued a total of 36 product recalls of HCT/Ps last year and shut down two tissue-recovery firms because of serious Good Tissue Practice violations.
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  • Majority of Biological Product Deviation Reports Related to Post-Donation Information - The FDA received 38,618 biological product deviation (BDP) reports for fiscal year 2006, 72 percent of which stemmed from donor-suitability problems that were not detected during initial donor interview.
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  • FDA Guidance Pertaining to Certain HCT/Ps: Three Recommended Actions - Less than a year after the FDA’s new donor screening and testing regulations became effective, there were 77 HCT/P deviations reported. So, it was not much of a surprise that the agency recently issued a guidance pertaining to certain HCT/Ps.
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  • Four Things You Need to Know About FDA's Guidance for Tissue Establishments - After the FDA shut down two tissue-recovery firms last year because of serious GTP violations, the agency issued a guidance reminding the industry to comply with the regulation.
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  • 21 CFR Part 601 and Accelerated Vaccine Approval: Five Things You Need to Know - 21 CFR Part 601 is the basis for CBER’s authority to grant accelerated vaccine approval. Here are five things you need to know about the program.
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  • What To Expect After an FDA Inspection - For those who just survived an FDA inspection, or those preparing for one, the question is: What happens after inspection?
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  • Blood Center Accreditation by CAP Can Boost FDA Compliance - What’s CAP accreditation got to do with FDA compliance? Considered one of the strictest standards today for clinical labs, CAP could serve as a shot in the arm for your FDA compliance initiatives.
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