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Professionals in the field of statistical analysis need a clear and perceptive insight into how to understand and interpret statistical concepts used to investigate quantitative ICH Guidelines such as analytical methods validation, procedures and acceptance criteria in calibration limits. Along with these, process and quality controls, as well as ICH Q8 and Q9 also need to be properly and thoroughly understood.
The ICH tripartite-harmonized ICH…
ContinueAdded by John Robinson on May 3, 2017 at 6:18am — No Comments
Shrink investigation is essentially about examining the causes of shrink (loss) in retail businesses. Although retail is one of the fastest growing areas of business, the possibility of shrink is very high in this area. It is also an overlooked area, because of which many shrinks that could otherwise have been prevented, do not get prevented.
Controlling losses is as important…
Added by Adam Fleming on April 21, 2017 at 6:03am — No Comments
Regulatory agencies the world over have put in place stringent requirements for ensuring that cleaning validation procedures for analytical equipment are effective. Even if putting these practices in place involves expense and effort, it is worth the trouble, because the cost of noncompliance is much, much higher than that of compliance.
Noncompliance with regulations for cleaning validation procedures for analytical equipment has a serious consequence: Regulatory…
Added by Adam Fleming on March 30, 2017 at 6:43am — No Comments
Establishing Quality Systems is one of the central aspects of a medical device and/or pharmaceutical organization. Establishment of Quality Systems is also a regulatory requirement, as set out by the FDA and the ISO.
The process of establishment of Quality Systems for FDA-regulated medical devices industries is set out in 21 CFR Part 820. Further, the ISO has its standard for how to establish Quality Systems in medical devices industries –the ISO 13485 standard…
Added by Adam Fleming on March 28, 2017 at 9:06am — No Comments
The Internal Revenue Service (IRS) has guidelines and laws for the way fringe benefits have to be taxed. First, an introduction to fringe benefits: Anything that is in addition to a person’s regular salary may be termed a fringe benefit. It is usually linked to an employee’s performance. Some of the common types of fringe benefits include children’s education, vehicle for commuting to the workplace and back, health insurance, retirement benefits and many others.…
Added by Adam Fleming on March 20, 2017 at 6:23am — No Comments
Lyophilization and its validation and regulatory approaches form an important aspect of parenteral drugs.
Lyophilization is a process in which a product is frozen and placed in a vacuum and water is removed from it. This removes the need for the liquid stage in the change of ice from solid to vapor. This process consists of three phases: primary, sublimation and desorption.
Lyophilization is considered complex
Parenteral products such…
Added by Adam Fleming on March 15, 2017 at 6:17am — No Comments
Design of Experiments (DoE) is an important component in many industries. It is a series of tests or runs that is carried out repeatedly and consistently over a period of time, and its outputs or responses, observed. Design of Experiments is very important in industry to help arrive at an understanding of the predictability and reproducibility of an experiment.
Design of…
Added by Adam Fleming on March 8, 2017 at 5:12am — No Comments
The International Financial Reporting Standards (IFRS) standards are a set of standards pertaining to different industries and their activities and practices. IFRS 6 relates to guidance in the accounting practices of the extractive industries, such as oil, mining and gas. The IFRS 6 accounting standard states the requirements, as well as the disclosures that need to go into accounting practices for expenses that a company incurs during the course of exploring and…
Added by Adam Fleming on March 6, 2017 at 5:38am — No Comments
Humans can be calibrated, although most people like to think otherwise. The commonly used standard, Attribute Agreement Analysis, or what is called AAA, is a handy tool in helping to do this. At its barest, Attribute Agreement Analysis is a method in which the level of agreement or conformance between the appraisal made by the appraiser(s) and the standard is assessed. Then, the elements used for the appraisal that have the highest levels of disagreement with the standard are…
ContinueAdded by Adam Fleming on February 15, 2017 at 5:54am — No Comments
Product Reliability is among the most important attributes for a product, no matter what kind of product one is considering. Product Reliability can be defined as the likeliness or probability of the product performing its stated purpose, in the light of the conditions under which it is going to be put, for a defined period of time.
The parameters used for quantification of Product Reliability are:
o MTBF or Mean Time Between Failures for products that can be repaired and…
ContinueAdded by Adam Fleming on February 13, 2017 at 5:40am — No Comments
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.…
Added by Adam Fleming on November 11, 2016 at 4:39am — No Comments
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…
Added by Adam Fleming on October 27, 2016 at 5:50am — No Comments
An audit management system can be understood as a set of audit systems that an organization puts in place to ensure that it meets its objectives. All organizations need to have their own audit management systems. An audit management system is a system that facilitates the management of…
Added by Adam Fleming on October 19, 2016 at 5:40am — No Comments
FDA Code of Federal Regulations (CFR) is a huge sea of regulations that the FDA has created for regulating all products that come under its purview of regulation. The FDA codes of federal regulations are numbered and cover all products, processes and the activities that go into their creation.
The FDA Code of Federal Regulations is a compendium of codified general and permanent rules the federal…
ContinueAdded by Adam Fleming on October 6, 2016 at 5:46am — No Comments
Design of Experiments (DoE) is defined as a systematized means with which the factors that go into a process and its intended output can be determined. DoE makes extensive use of statistical and experimentation means. DoE helps to optimize the processes of production in a number of environments in a huge range of industries.
The varied uses of DoE
DoE is useful in a number of applications. For instance, it:
o Helps determine root…
Added by Adam Fleming on September 21, 2016 at 6:28am — No Comments
The criticality of risk analysis to HIPAA implementation can be understood from the fact that inability to carry out this activity is the principal reason for which The United States Department of Health and Human Services (DHHS or just HHS) levies civil money penalties on Business Associates and Covered Entities.
This means that Covered Entities and…
ContinueAdded by Roger Steven on September 2, 2016 at 6:56am — No Comments
Implementation of Regulatory Aspects of Clinical Research is critical
One of the prime areas of clinical studies is regulatory aspects of clinical research. This applies in almost equal measure to medical research as a whole. The FDA and other…
ContinueAdded by Roger Steven on May 27, 2016 at 5:07am — No Comments
Nanotechnology is making fast advances in medicine. I have written about it before here and in "The Future of Medicine - Megatrends in Healthcare." A nanometer is one billionth of a meter. New science and technology based on the nanometer refers to the ability to manipulate individual atoms and molecules to build machines on a scale of nanometers or to create materials and structures from the bottom up with novel properties.…
ContinueAdded by Stephen C Schimpff on October 29, 2013 at 11:43am — No Comments
There are just a few key reasons why Medicare has become inordinately expensive. There is no end in sight for cost escalation. But there are some obvious solutions and they all begin with chronic illnesses.
Chronic illness – diabetes, heart failure, cancer, chronic lung disease, etc. – are increasing at exponential rates; are caused largely by lifestyle behaviors; and…
ContinueAdded by Stephen C Schimpff on October 9, 2013 at 4:04pm — No Comments
Imagine a person that develops an acute problem that requires hospitalization and even a time in the ICU. Serious but something that modern medical care can deal with and cure. Until …the patient now develops an unexpected serious infection and despite excellent and appropriate medical care, dies. Unfortunately this scenario is all too common in today’s hospitals.
More than 100,000 Americans die each year from hospital acquired infections; that is the infection developed only…
ContinueAdded by Stephen C Schimpff on July 4, 2012 at 3:16pm — No Comments
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