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Adam Fleming's Blog – September 2016 Archive (12)

Part 11 inspections from the FDA and ways of steering clear of inviting 483’s and Warning Letters

The ongoing Part 11 inspection and enforcement program is the mechanism by which the FDA continues to enforce implementation of Part 11. Using this method, this regulatory agency has, in just the last four years, issued more than 30 Warning Letters for deviations from Part 11. The most important reasons for which citations get issued by the FDA relate to insufficient integrity, security and availability of electronic records, as well as validation of software and computer…

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Added by Adam Fleming on September 30, 2016 at 6:57am — No Comments

Tightening carrier food safety issues can save costs for the food and logistics industries

The fact that between five and eight percent of current recall and shipment rejection issues happen within the cold chain food transportation sector, resulting in fairly high, but preventable financial loss is an indication of how much scope is there to contain seepage in the food and transportation industries.

Is this happening because of lack of regulation? No. Rather, it is…

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Added by Adam Fleming on September 29, 2016 at 6:00am — No Comments

Elements of a Cyber Security Incident Response Program

A Cyber Security Incident Response Program (CSIRP) or a Cyber Security Incident Response Team (CSIRT) that anticipates and neutralizes a cyber-incident is a critical need for organizations, because an Internet or network security breach results in loss of valuable data, as well as several resources and the organization’s reputation and could potentially invite lawsuits.

While putting a CSIRP in place; the management has to take into consideration…

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Added by Adam Fleming on September 23, 2016 at 6:04am — No Comments

Managing healthcare projects with ease and simplicity

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…

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Added by Adam Fleming on September 22, 2016 at 6:00am — 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…

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

Exploring the FDA’s guidance on financial disclosure by clinical investigators

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…

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Added by Adam Fleming on September 20, 2016 at 6:22am — No Comments

Designing your retail store for the old and new generations

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…

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Added by Adam Fleming on September 19, 2016 at 5:57am — No Comments

The right way of choosing sample sizes based on valid statistical rationale

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…

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Added by Adam Fleming on September 16, 2016 at 6:29am — No Comments

Article on Understanding the NI 43-101

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…

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Added by Adam Fleming on September 15, 2016 at 6:37am — No Comments

Getting their documentation right is very important for medical device manufacturers

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?…

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Added by Adam Fleming on September 13, 2016 at 6:52am — No Comments

Good documentation lies at the heart of GxP environments

Good Documentation Practice (GDP) constitutes the backbone of any GxP environment. Not only is GDP a sound business practice; it is also an FDA requirement. This being the case, it is absolutely essential for FDA-regulated organizations to get their GDP right. An organization that does not get its GDP right risks facing a number of consequences.

Today’s regulatory requirements are stricter than ever before. In this environment of very rigid regulatory environment;…

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Added by Adam Fleming on September 6, 2016 at 7:57am — No Comments

Microbial monitoring becomes successful when myths about the topic are removed

Although unfortunate; it is true that those who work in water systems design them keeping obsolete concepts in mind. Why this happens is that the water systems organization is reluctant to be open-minded enough to update its water systems from time to time. The result is that the water systems get built on a shaky foundation, making them fundamentally weak.

Myths are the backbone of water systems failures

An additional problem faced by most microbial monitoring…

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

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