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All Blog Posts Tagged 'in' (71)

Quality Assurance Auditing for FDA-regulated industries

Quality Assurance Auditing for FDA-regulated industries5

An effective audit constitutes the heart of an effective Quality System. The FDA and other regulatory agencies have emphasized this principle time and again. The purpose of an audit program is to ensure proper and thorough compliance with the guidelines set out by the regulatory agencies. A…

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Added by John Robinson on July 26, 2017 at 5:52am — No Comments

An integrated approach is needed for Complaints Handling, Adverse Event Reporting, and Recalls

Adverse Event Reporting, and Recalls4

The fact that medical device manufacturers work and operate in various regulatory systems whose requirements are different and not always consistent with each other is recognized and empathized by the…

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Added by John Robinson on July 21, 2017 at 5:56am — No Comments

Understanding opportunities in NAFTA

The North American Free Trade Agreement (NAFTA) came into being on the first day of 1994. While the US and Canada had been having free trade agreements that go back at least three decades culminating in the US-Canada Free Trade Agreement of January 1, 1989; NAFTA became a reality following Canada’s entry in 1991 into the bilateral talks between the US and Mexico, creating the trilateral FTA.

One of the primary objectives of the NAFTA was the elimination of a number of duties and…

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Added by Adam Fleming on July 20, 2017 at 5:26am — No Comments

Understanding and responding to the special needs of college students who have autism

When people with autism spectrum disorder (ASD) –called just autism –enter college, they are up against challenges that are unique and peculiar to the group. They need to be understood for their special needs, because they enter college at a sensitive age. There is an onus on the part of the other people in the college, such as peer students and staff and those in…

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Added by Roger Steven on July 12, 2017 at 7:43am — No Comments

Do human factors matter in medical devices?

Do human factors matter in medical devices1

Is there a relationship between medical devices and human factors? This is a question that is seriously worth exploring. According to the ANSI/AAMI HE75:2009 document, human factors is an endeavor for optimizing the production of devices, systems, and many others concerned with them through the use of emotional, intellectual,…

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Added by John Robinson on July 12, 2017 at 6:21am — No Comments

Guarding against cyberattacks

Data breaches, malware and related frauds can cost an organization very dearly. The effects of cyber fraud are rather alarming:

It was estimated that cyberattacks amounted to a loss of at least a trillion dollars to the US economy in 2013, up by more than 25% over the previous year. The US continues to be the largest target and sufferer of cyberattacks. It accounts for more than a third of all cyberattacks that happen all around the world, followed by India, which is a distant second,…

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Added by Adam Fleming on July 10, 2017 at 5:19am — No Comments

Advantages and disadvantages of Electronic Health Records

Electronic Health Records (EHR) or electronic medical records (EMR), as they are called, are of enormous use in the fields of healthcare and medical sciences. They have a number of features that enable the patient; the medical professional and the healthcare provider have complete and unimaginably easy access to all important records that relate to the patient.

A direct result of the…

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Added by Roger Steven on June 29, 2017 at 7:52am — No Comments

Documenting Software for FDA Submissions

Files

The Agile methodology is an important tool for software project management. It emerged out of the gradual efforts at arriving at a team based methodology of iterative software development. Its close association with software makes it as suitable to this field as Lean is to manufacturing.…

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Added by John Robinson on June 27, 2017 at 6:15am — No Comments

Food safety concerns and issues and ways of mitigating them

Food, despite being the most important human need, is fraught with many risks and hazards. The food chain, which consists of activities that cover everything from the proverbial farm to fork, passes through many points at which a harm of any nature can happen. The chances of risks to the food safety chain are all the more amplified in this age of globalization, when food travels through many regions and continents from its source to its destination.…

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Added by Adam Fleming on June 14, 2017 at 6:09am — No Comments

Change Control is at the core of GMP Compliance

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Added by John Robinson on June 13, 2017 at 6:46am — No Comments

Quality by Design using Design of Experiments

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Added by John Robinson on June 8, 2017 at 6:48am — No Comments

HIPAA compliance for offshore vendors

In this age of outsourcing and globalization, and with it, the emerging potential phenomenon of the Internet of Things (IoT); it is quite a tempting proposition for HIPAA Business Associates or Covered Entities to think of outsourcing their processes relating to Protected Health Information (PHI). However, as is to be expected, there is risk involved in outsourcing this kind of critical information, given the critical importance of these healthcare records and in view of the fact that there…

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Added by Roger Steven on May 26, 2017 at 8:28am — No Comments

“Understanding the practical application of statistics?”

The application of statistical methods is specified all through 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries for these activities:

o  Setting validation criteria and specifications

o  Performing…

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Added by John Robinson on May 19, 2017 at 5:52am — No Comments

Key issues in HR auditing

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Added by John Robinson on May 15, 2017 at 5:30am — No Comments

How to implement technology transfer in pharmaceuticals

Technology transfer is a process that has gained widespread acceptance and prominence in many areas of knowledge all over the world today. Technology transfer can be broadly defined as the way in which technology is transferred from the source of its origin of creation to sources from where it can be developed and/or distributed to a wider area.

Technology transfer is carried out in a number of…

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Added by Adam Fleming on May 10, 2017 at 6:41am — No Comments

All about human error and ways of reducing it

There is the saying that after all is said and done, to err is human. In a philosophical sense, it can have numerous interpretations, but in the field of Good Manufacturing Practice, it cannot be taken with a pinch of fatalism. GMP requires everything to be precise and scientific to a T. GMP is not an area that leaves anything to human error. Being an area of science, GMP has no place for imagination and chance.…

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Added by Adam Fleming on May 8, 2017 at 7:48am — No Comments

Article on “Statistical Sampling Plans for Medical Devices”

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Added by John Robinson on April 21, 2017 at 6:04am — No Comments

FDA and EU requirements on data integrity and implementation

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Added by John Robinson on April 17, 2017 at 5:49am — No Comments

Applied Statistics for FDA Process Validation 2017

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Added by John Robinson on April 12, 2017 at 5:30am — No Comments

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