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Adam Fleming's Blog (255)

The Taxpayer Identification Number (TIN) matching feature of the IRS

Any company or individual that is required to submit IRS Form 1099 can avail a facility the Internal Revenue Service (IRS) has: the Taxpayer Identification Number (TIN) matching. This matching or likeness is among an assortment of e-services that gives what are called “authorized payers” the opportunity to match and state their own 1099 payee information with the pertinent records from the IRS. The TIN matching is a pre-filing facility, since it is done before an entity files information…

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Added by Adam Fleming on February 8, 2017 at 5:58am — No Comments

Expect drastic changes to the in-vitro diagnostics market in the upcoming years

The in-vitro diagnostics (IVD) market is a diverse and fast changing one. Of late, one of the significant changes that happened to it resulted from the passage of the Final Rule. As part of the Affordable Care Act (ACA) or Obamacare, the Centers for Medicare and Medicaid Services (CMS) introduced the Final Rule to the 2014 Protecting Access to Medicare Act (PAMA) in mid-2016, which is set to make a significant impact on the in-vitro diagnostics market by delaying implementation of…

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Added by Adam Fleming on February 6, 2017 at 6:21am — No Comments

Making financial institution’s payment franchise stronger

Financial institutions have long been the most important source of payments for their customers. Of late, though, with an increase in competition and the advent of new non-bank entries into the marketplace, financial institutions have come under a lot more strain than they used to be.

Financial institutions need to reinvent themselves in a number of ways. They need to adapt novel strategies to…

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Added by Adam Fleming on November 25, 2016 at 5:03am — No Comments

The importance of “Management Responsibility” for medical device companies

Compared to bigger actions, Recalls, 483s, Warning Letters and consent decrees are only some of the milder parts of punishments that the FDA could impose on a medical device company that fails to meet regulatory requirements. The bigger actions can include seizure, injunction, and civil money penalties. The Park Doctrine allows executives to even be sentenced to prison.

In the…

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Added by Adam Fleming on November 22, 2016 at 4:50am — No Comments

Controlling pests in food processing and foodservice

Food establishments continue to be a major source for pests due to the changes brought about in the means and ways by which food is produced and handled and in the ways of preparation techniques and eating habits. The pests in turn are sources for illness-causing microorganisms. The more knowledge about pest control at their disposal; the better it is for food processing and foodservice personnel, because this is essential for ensuring a safe food supply for consumers.…

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Added by Adam Fleming on November 17, 2016 at 4:43am — No Comments

Lineament analysis as a modern tool to look for ore deposits

For those in the field of exploration, there is a need to zero in on an effective and affordable methodology that identifies prospective targets which are related to, or controlled by tectonic structures. This methodology should help explorers concentrate their exploration efforts over new areas keeping their budget in control, armed even with limited or nonexistent geological information.…

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Added by Adam Fleming on November 16, 2016 at 4:47am — No Comments

Getting a grasp of the FDA’s New Enforcement of 21 CFR Part 11

That the FDA has become more rigorous in the enforcement of Part 11 through its new Part 11 and on-going data integrity inspection and enforcement program is evident in this: In just the last three years, it issued more than 30 Warning Letters with Part 11 and data integrity violations. The most common citations are related to not only inadequate integrity, security and availability of electronic records, but also to validation of software and computer systems.…

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Added by Adam Fleming on November 15, 2016 at 4:44am — No Comments

Putting in place food processes that facilitate traceability and recall

The Food Safety Modernization Act (FSMA) has strengthened the FDA’s enforcement authority. The FDA now has the authority to not only mandate product recalls; the records and information they may request to see have increased as well. What has also gone up is the FDA’s documentation review authority.

Allergen mislabeling microbiological and foreign material contamination are the…

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Added by Adam Fleming on November 14, 2016 at 4:38am — No Comments

Managing a medical device recall efficiently and effectively

A medical device recall means the correction or removal of a device for human use where FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death. It is an action taken to address a problem with a medical device that violates FDA law. Recalls are made when a) a medical device is defective; b) when it could be a risk to health, or c) when it is both defective and a risk to health.…

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Added by Adam Fleming on November 11, 2016 at 4:39am — No Comments

Making Big Data big in terms of effectiveness

Our world today is unthinkable without data. We seem to be flooded by it. Day in and day out, the world processes trillions of bytes. Big Data seems to be everywhere and has compounded our already heavy reliance on data.

But has this proliferation of data made any significant difference to our lives? Has it made our business decision-making any more effective or insightful?…

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Added by Adam Fleming on November 10, 2016 at 4:23am — No Comments

The criticality of determining the right sample size

Among the most important aspects that need to be taken into consideration in any application is the sample size. The sample size, when taken accurately, can be a very reliable guide to the whole. When the wrong sample size is taken for magnification, it could lead to wrong results, throwing the whole exercise into disarray. Determining the right sample size is thus of utmost importance to any application. There are scientific and verifiable means of doing this.…

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Added by Adam Fleming on November 9, 2016 at 4:24am — No Comments

Ensuring sanitization of food products

Maintaining clean conditions in the entire food operation is essential for ensuring effective sanitation in the food industry. This can be brought about only when the residual microorganisms are destroyed after the production, storage and service areas of food establishments are cleaned thoroughly.

washing-tomato-2500 Ensuring a microorganism-free environment is a huge challenge for those in the food industry. This is because activities related to food, such as food production, handling,…

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Added by Adam Fleming on November 8, 2016 at 5:01am — No Comments

Current trends in Maintaining an Effective CAPA Program and Using Risk Assessment Tools

A measure of the criticality of CAPA to medical device manufacture can be ascertained from the fact that the FDA considers the strength of a manufacturer’s CAPA program as the criterion for deciding how strong or weak he is. Given this fact, it pays to have a watertight CAPA system in place.

Risk-based CAPA is the latest stage in the evolution of the CAPA model. These days, the medical devices industry is using various risk-based approaches and tools to set-up,…

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Added by Adam Fleming on November 7, 2016 at 4:52am — No Comments

Ways of Carrying out HPLC Analytical Method Development and Validation

In the field of pharmaceuticals, instrumental liquid chromatography is an analysis widely used to determine purity, the impurities, and the degradation of products. The Standard Operating Procedure (SOP) is the area on which most validation work is focused. However, auditors look for other areas, such as validation of the instrumentation and other associated items of column, solvents, and other reagents and chemicals.…

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Added by Adam Fleming on November 4, 2016 at 5:57am — No Comments

Mitigating the pain of an RFP process

Utmost care has to go into a financial institution’s Cash Management and credit RFP process, which is quite a painful process. One needs to think about the whole process and get a thorough understanding of it before entering this exercise.  This understanding will go a long way in helping to ease the pain of the process, but is in itself quite an exercise.

A clear understanding…

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Added by Adam Fleming on November 3, 2016 at 6:14am — No Comments

Risk of omission is a critical one in Quality

Omission is a very important, but often overlooked aspect of Quality. It is often not realized in most organizations that the risk not doing a thing right, or what may be termed risk of omission, usually outweighs and is far more dangerous than the risk of what they do wrong, or what is a result of poor quality. The best way to understand the importance of this paradigm is that poor quality generally comes out or makes itself known during inspections and tests, or when…

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Added by Adam Fleming on November 2, 2016 at 6:12am — No Comments

Standardizing Transportation Procedures is Necessary to Control Food Safety and Quality

Building a standardized sanitary transportation system in compliance with the FSMA’s new Proposed Rules for the sanitary transportation of human and animal foods is included in the FDA's FSMA hazard analysis risk-based preventive controls requirements for improved food safety during transportation processes. For this reason, food transporters need to have a clear understanding of these rules. The consequence of the inability to establish and keep required documentation is predictable: It makes… Continue

Added by Adam Fleming on October 28, 2016 at 5:52am — No Comments

Extracting Information from Geochemical Data

Going beyond just asking the laboratory for geochemical extracting information of a gold test by sampling every meter of the drill core of a trench and using multielement analysis is an approach strongly recommended by most mining specialists. There exist other methods of geochemical data analysis techniques and obtaining geochemical extracting information, but these are largely ignored by the industry.

Making sense of the geochemical extracting…

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Added by Adam Fleming on October 27, 2016 at 5:50am — No Comments

Diligence is Necessary for Postmarketing Vigilance Reporting for Medical Device Manufacturers

A few important postmarketing vigilance revisions are now being implemented. One of these is the revised medical device guidance document on postmarketing vigilance (MEDDEV 2.12-1 rev 5), which came into force on January 1, 2008.

Offering greater clarity and more guidance than the previous version, the new document includes new reporting terminology and many new concepts. It has also excised or added new, important terms.…

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Added by Adam Fleming on October 26, 2016 at 5:59am — No Comments

The ways of Understanding, Calculating, and Using Statistical Power

Statistical power may be understood as being an indicator of the ability of a test of significance to spot a practical difference, such as the one between the averages of two products that are being compared. In this context, a low power typically means that the sample sizes in the study are too small. Conclusion of what is “non-significant” is justifiably questionable when it is arrived at without an analysis of statistical power. For this reason, unless power is high, a study may be doomed…

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Added by Adam Fleming on October 25, 2016 at 6:06am — No Comments

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