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Compliance4all
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Compliance4all posted a blog post

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.The IRS taxes certain kinds of…See More
Monday
Compliance4all posted blog posts
Mar 16
Compliance4all posted a blog post

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 something like $100 million over a…See More
Mar 13
Compliance4all posted a blog post

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 assurance that the FDA holds a…See More
Mar 10
Compliance4all posted a blog post

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 Experiments is a very important aspect of the important elements of a product, such as quality, reliability and performance.…See More
Mar 8
Compliance4all posted a blog post

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 most important aspect of the…See More
Mar 3
Compliance4all posted a blog post

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 identified.The two…See More
Feb 15
Compliance4all posted a blog post

Making financial institution’s payment franchise stronger

Financial institutions have long been the most important source of payments for their customers. Of late, though, with an increase in competition and the advent of new non-bank entries into the marketplace, financial institutions have come under a lot more strain than they used to be.Financial institutions need to reinvent themselves in a number of ways. They need to adapt novel strategies to capitalize on the existing trust and the customer experience to reverse the trend in order to get back…See More
Nov 25, 2016
Compliance4all posted a blog post

The importance of “Management Responsibility” for medical device companies

Compared to bigger actions, Recalls, 483s, Warning Letters and consent decrees are only some of the milder parts of punishments that the FDA could impose on a medical device company that fails to meet regulatory requirements. The bigger actions can include seizure, injunction, and civil money penalties. The Park Doctrine allows executives to even be sentenced to prison.In the legal sense, strict liability means that a prosecutor does not need to prove criminal intent. Any other means, such as…See More
Nov 22, 2016
Compliance4all posted blog posts
Nov 17, 2016
Compliance4all posted a blog post

Getting a grasp of the FDA’s New Enforcement of 21 CFR Part 11

That the FDA has become more rigorous in the enforcement of Part 11 through its new Part 11 and on-going data integrity inspection and enforcement program is evident in this: In just the last three years, it issued more than 30 Warning Letters with Part 11 and data integrity violations. The most common citations are related to not only inadequate integrity, security and availability of electronic records, but also to validation of software and computer systems.Among the most important questions…See More
Nov 15, 2016
Compliance4all posted a blog post

Putting in place food processes that facilitate traceability and recall

The Food Safety Modernization Act (FSMA) has strengthened the FDA’s enforcement authority. The FDA now has the authority to not only mandate product recalls; the records and information they may request to see have increased as well. What has also gone up is the FDA’s documentation review authority.Allergen mislabeling microbiological and foreign material contamination are the leading causes of Class I recalls. Given this fact, the need is for developing quality systems that result in good…See More
Nov 14, 2016
Compliance4all posted a blog post

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.When an implanted device has the potential to fail…See More
Nov 11, 2016
Compliance4all posted blog posts
Nov 10, 2016
Compliance4all posted a blog post

Ensuring sanitization of food products

Maintaining clean conditions in the entire food operation is essential for ensuring effective sanitation in the food industry. This can be brought about only when the residual microorganisms are destroyed after the production, storage and service areas of food establishments are cleaned thoroughly.Ensuring a microorganism-free environment is a huge challenge for those in the food industry. This is because activities related to food, such as food production, handling, preparation techniques and…See More
Nov 8, 2016
Compliance4all posted a blog post

Current trends in Maintaining an Effective CAPA Program and Using Risk Assessment Tools

A measure of the criticality of CAPA to medical device manufacture can be ascertained from the fact that the FDA considers the strength of a manufacturer’s CAPA program as the criterion for deciding how strong or weak he is. Given this fact, it pays to have a watertight CAPA system in place.Risk-based CAPA is the latest stage in the evolution of the CAPA model. These days, the medical devices industry is using various risk-based approaches and tools to set-up, deploy and maintain their CAPA…See More
Nov 7, 2016

Profile Information

Area of Expertise or Interest?
Compliance4All has experts who share a wealth of knowledge covering best practices in industry. These trainings help participants refresh their knowledge about regulatory compliance. Our panel of Experts imparts learning on a number of areas relating to compliance, such as:

Medical Devices
Pharmaceutical
Food
PCI industries, and
SOX

Our webinars cover the following Governing Areas:

FDA
GxP (Manufacturing/Clinical/Lab)
CMDR
EU
ISO
SOX and
PCI

These are the functional areas Experts from Compliance4All offer their expertise on:

Regulatory
Clinical Trials, and
Quality
Type of Affiliation?
Academia or NonProfit
Years of Experience in MedTech Field
10
About Me
Compliance4All, the ultimate continuing professional education provider offers you regulatory and compliance trainings from the industry's leading experts, but with one crucial difference -the cost. Compliance4All's objective is to be a platform that provides regulatory and compliance trainings with all the class and features that come with these trainings, at a lower price. Compliance4All seeks to make regulatory and compliance trainings low-hanging fruits.
Professional Objectives
Compliance4All's objective is to be a platform that provides regulatory and compliance trainings with all the class and features that come with these trainings, at a lower price. Compliance4All seeks to make regulatory and compliance trainings low-hanging fruits.

Compliance4all's Blog

Taxable and nontaxable fringe benefits

Posted on March 20, 2017 at 6:23am 0 Comments

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

A look into the 21st Century Cures Act

Posted on March 16, 2017 at 6:00am 0 Comments

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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Lyophilization: Validation and regulatory approaches

Posted on March 15, 2017 at 6:17am 0 Comments

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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Understanding and handling payment issues

Posted on March 13, 2017 at 6:02am 0 Comments

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…

Continue

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