Adam Fleming's Blog (255)

Those in the healthcare sector go about their work like they are completing a project. Their work is made up of many parts, all of which they need to approach using many processes and plans. In keeping a tight watch on the budget and the deadline; many aspects of the work get overlooked, as a result of which the outcome suffers.

Each team member has a specific and important task in healthcare. All these have to be done with precision and in close synchrony with the…

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…

Transparency and integrity of the financial interests of clinical investigators is a matter of utmost importance to the healthcare industry in the US. The financial interests of the investigators are directly associated with the results, thinks the FDA. It believes that “financial interests and arrangements of clinical…

The demographic profile of the nation has a direct and very important bearing on the productivity of an organization. There is a common perception that the Baby Boomers are on their way out and are making way for Gen X. While this is true to on the surface, in the sense that Gen X is the next phase of the workforce; the Baby Boomers are certainly not done yet.

The key to getting more out of the American workforce is to analyze how one generation…

Performing at least some verification testings or validation studies of design-outputs and/or manufacturing processes is essential for almost all manufacturing and development companies. Yet, it is sometimes difficult to explain the rationale that goes into the selection of the sample sizes used in such efforts.

Removing this doubt and showing participants a way out of this quandary will be the content of a webinar that Compliance4All, a leading…

The NI (short for National Instrument) 43-101 is a Canadian national instrument used for the Standards of Disclosure for Mineral Projects within the country. This is a codified set of rules and regulations used to report and exhibit information relating to mineral properties owned by, or explored by companies that report these findings on the nation’s stock exchanges.

The NI 43-101 came into existence in the wake of the notorious Bre-X scandal. It…

Documentation is at the heart of medical devices. If a medical device manufacturer cannot convincingly establish documentation of the manufacturing process; the medical device is bound to have regulatory approval hurdles. Every medical device manufacturer has to both establish and maintain all of these: documents, procedures and records, all of which must be under a state of control.

So, what should the documentation establish and prove?…

Clinical research regulations are directives that are aimed at making clinical research more effective and ethically justifiable. The tool or mechanism by which regulators ensure that clinical research regulations serve their purpose is what is called Good Clinical Practice (GCP).

Regulatory bodies around the world, irrespective of whether they function at national or global levels, formulate respective clinical research regulations that are aimed at ensuring that…