MedTech I.Q.

The Cutting Edge of Medical Technology Content, Community & Collaboration

All Blog Posts Tagged 'of' (103)

Validation in accordance with ICH guidelines

Chemical

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…

Continue

Added by John Robinson on May 3, 2017 at 6:18am — No Comments

Understanding the ways of conducting shrink investigations

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…

Continue

Added by Adam Fleming on April 21, 2017 at 6:03am — No Comments

Effective cleaning validation procedures for analytical equipment

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…

Continue

Added by Adam Fleming on March 30, 2017 at 6:43am — No Comments

Establishing Latest Quality Systems in medical device and pharmaceutical industries

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…

Continue

Added by Adam Fleming on March 28, 2017 at 9:06am — No Comments

Taxable and nontaxable fringe benefits

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.…

Continue

Added by Adam Fleming on March 20, 2017 at 6:23am — No Comments

Lyophilization: Validation and regulatory approaches

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…

Continue

Added by Adam Fleming on March 15, 2017 at 6:17am — No Comments

The importance of Design of Experiments (DoE)

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…

Continue

Added by Adam Fleming on March 8, 2017 at 5:12am — No Comments

International Financial Reporting Standards (IFRS) 6

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…

Continue

Added by Adam Fleming on March 6, 2017 at 5:38am — No Comments

The Attribute Agreement Analysis

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…

Continue

Added by Adam Fleming on February 15, 2017 at 5:54am — No Comments

Demonstrating Product Reliability

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…

Continue

Added by Adam Fleming on February 13, 2017 at 5:40am — 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.…

Continue

Added by Adam Fleming on November 11, 2016 at 4:39am — 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…

Continue

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

Understanding an audit management system

Continue

Added by Adam Fleming on October 19, 2016 at 5:40am — No Comments

The FDA code of federal regulations

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…

Continue

Added by Adam Fleming on October 6, 2016 at 5:46am — No Comments

DoE helps in optimizing processes and output in a number of ways

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…

Continue

Added by Adam Fleming on September 21, 2016 at 6:28am — No Comments

Risk analysis is the soul of HIPAA implementation

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…

Continue

Added by Roger Steven on September 2, 2016 at 6:56am — No Comments

Implementation of Regulatory Aspects of Clinical Research is critical

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…

Continue

Added by Roger Steven on May 27, 2016 at 5:07am — No Comments

Nanomedicine - A Key Component to the Future of Medicine

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.…

Continue

Added by Stephen C Schimpff on October 29, 2013 at 11:43am — No Comments

A “Grand Bargain” To Improve Quality and Decrease Medicare Costs

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…

Continue

Added by Stephen C Schimpff on October 9, 2013 at 4:04pm — No Comments

Antibiotic Resistant Bacteria Are A Major Threat – Preventing Transmission is Critical

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…

Continue

Added by Stephen C Schimpff on July 4, 2012 at 3:16pm — No Comments

Monthly Archives

2022

2020

2019

2018

2017

2016

2015

2014

2013

2012

2011

2010

2009

2008

1999

© 2024   Created by CC-Conrad Clyburn-MedForeSight.   Powered by

Badges  |  Report an Issue  |  Terms of Service