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Adam Fleming's Blog (22)

Works Quickly Meeting the FDA’s Quality and compliance requirements

Quality and compliance are vital issues for any medical devices company. Despite the fact that the FDA’s regulatory compliance requirements are the same across the industry; many medical device companies are shocked when they receive a 483, or a Warning Letter, or even a consent decree. Is meeting the FDA’s regulatory requirements something of a chance, which some organizations get by fluke and others don’t?…

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Added by Adam Fleming on March 24, 2017 at 6:31am — 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.…

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

A look into the 21st Century Cures Act

Considered one of the most significant changes to be introduced into the American healthcare sector since the passage of the Affordable Care Act; the 21st Century Cures Act was one of the last legislative acts of outgoing president Barack Obama. Signed into law in December 2016; the 21st Century Cures Act seeks to strengthen medical research, foster innovation and accelerate the development of innovative treatments for chronic ailments such as cancer.…

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Added by Adam Fleming on March 16, 2017 at 6:00am — 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…

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

Understanding and handling payment issues

A financial organization, or an organization involved in any business for that matter, faces the prospect of receiving duplicate, fraudulent or late payments. These are the typical payment issues an organization is likely to face at some point of time in its business.

Payment issues are something almost no organization is likely to be free from. Duplicate invoice payments, just one of the payment issues an organization is likely to face, account for losses of…

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Added by Adam Fleming on March 13, 2017 at 6:02am — No Comments

Understanding normality tests and normality transformations

That the inputted data should be “normally distributed” is a requirement of the calculations used in many statistical tests and methods. Typically, the methods used for Student’s t-Tests, ANOVA tables, F-tests, Normal Tolerance limits, and Process Capability Indices include such calculations.

A core criterion for ensuring the correct results is the one that the raw data used in such calculations be “normally distributed”. It is in view of this fact that the…

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Added by Adam Fleming on March 10, 2017 at 5:39am — 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…

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

Analyzing financial statements is an indispensable insight for managers

Financial statements are the ultimate indicator of a company’s financial health. Number crunching is a very important exercise that all executives at all levels of an organization need to be familiar with. Yet, given the heavy jargon that goes into financial statements and the complexity most of them have; many managers feel put off and don’t generally like to pore over financial statements.

The company’s financial statement is intended to provide insights into the…

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Added by Adam Fleming on March 3, 2017 at 5:35am — 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…

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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…

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Added by Adam Fleming on February 13, 2017 at 5:40am — No Comments

Implementing cGMP quality systems and risk management approaches

After carrying out the initial preclinical studies, drug manufacturers need to implement cGMP quality systems and risk management approaches during commercial development and operations in order to be able to meet the requirements of the FDA’s current Good Manufacturing Practice (cGMP), which are contained in and are governed by regulations 21 CFR parts 210 and 211.

The FDA’s guidance on cGMP quality systems and risk management approaches is meant to help drug manufacturers implement…

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Added by Adam Fleming on February 10, 2017 at 6:08am — No Comments

The Taxpayer Identification Number (TIN) matching feature of the IRS

Any company or individual that is required to submit IRS Form 1099 can avail a facility the Internal Revenue Service (IRS) has: the Taxpayer Identification Number (TIN) matching. This matching or likeness is among an assortment of e-services that gives what are called “authorized payers” the opportunity to match and state their own 1099 payee information with the pertinent records from the IRS. The TIN matching is a pre-filing facility, since it is done before an entity files information…

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Added by Adam Fleming on February 8, 2017 at 5:58am — No Comments

Expect drastic changes to the in-vitro diagnostics market in the upcoming years

The in-vitro diagnostics (IVD) market is a diverse and fast changing one. Of late, one of the significant changes that happened to it resulted from the passage of the Final Rule. As part of the Affordable Care Act (ACA) or Obamacare, the Centers for Medicare and Medicaid Services (CMS) introduced the Final Rule to the 2014 Protecting Access to Medicare Act (PAMA) in mid-2016, which is set to make a significant impact on the in-vitro diagnostics market by delaying implementation of…

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Added by Adam Fleming on February 6, 2017 at 6:19am — No Comments

Quality is everything for a product or service

Quality is everything for a product or service. Quality is defined in different ways. One of the well-known definitions of Quality is the ability of a product or service to reach expected levels of excellence. This is a simple theoretical definition. In practice, though, Quality is a highly painstaking area of activity that is necessary across all functions of all industries. If a product does not meet its quality requirements or criteria, it is doomed to failure.…

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Added by Adam Fleming on February 3, 2017 at 8:01am — No Comments

Medical Device Regulatory and Quality professionals need to have essential knowledge to manage drug and device combination product projects

Medical Device Regulatory and Quality professionals need to have essential knowledge to manage drug and device combination product projects for a number of valid reasons. One of the main reasons is that medical device regulatory and quality professionals are often responsible for overseeing the development of combination products that include small or large drug “active pharmaceutical ingredients” to achieve the clinical therapeutic effect.…

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Added by Adam Fleming on January 20, 2017 at 5:19am — No Comments

Alternatives to AQL sampling plans do exist

Alternatives to AQL sampling plans do exist, but companies need to be aware of them and explore them. Acceptance Quality Limit, or AQL, is applied as a benchmark in most manufacturing organizations to inspect the quality of products they purchase. It is only when the product meets AQL that the receipt is acknowledged and the payment made.

So, what is AQL?

What is AQL? In simple terms, AQL, which expands to Acceptance Quality Limit, is what…

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Added by Adam Fleming on January 19, 2017 at 5:06am — No Comments

FDA Regulation of Combination Products is important to understand

FDA regulation of combination products is a very important aspect to keep in mind for pharmaceutical manufacturers. This is because of the complex nature of combination products. The definition for combination products is set out in 21 CFR 3.2 (e). Combination products assume importance in the industry because they combine two more drugs from different categories. This is what makes them unique. If a product is made out of two or more drugs from the same category, it does…

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Added by Adam Fleming on January 18, 2017 at 5:02am — No Comments

Post market surveillance needs to be robust to avoid penal regulatory action

Post market surveillance (PMS) is a very important activity for manufacturers of medical devices. It needs utmost care in handling, because the FDA considers post market surveillance as one of its primary means for protecting public health.

Post market surveillance is, in simple terms, the monitoring of the performance and quality of a medical device after it has been released…

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Added by Adam Fleming on January 17, 2017 at 6:54am — No Comments

It is necessary to understand the nature of the differences between GMP and GLP

Differences between GMP and GLP are important to understand for professionals who work in areas which involve these two different, yet related practices. Since the two appear somewhat similar in terms of their application and nomenclature; there is considerable scope for misunderstanding and confusion.

It is necessary to understand the nature of the differences between GMP and…

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Added by Adam Fleming on January 16, 2017 at 5:51am — No Comments

How to implement 21 CFR Part 11, which is about Compliance for Electronic Records and Signatures?

How to implement 21 CFR Part 11, the regulatory guideline which deals with compliance for electronic records and signatures, is a challenge for professionals in the medical devices and pharmaceutical industries. The FDA has set out 21 CFR Part 11 to help the regulated industries that come under its purview to structure their business processes…

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Added by Adam Fleming on January 13, 2017 at 5:18am — No Comments

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