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Adam Fleaming
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  • Fremont, CA
  • United States
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Adam Fleaming 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
Adam Fleaming posted a blog post

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 used, ando  MTTF or…See More
Feb 13
Adam Fleaming posted a blog post

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 the most…See More
Feb 10
Adam Fleaming posted a blog post

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…See More
Feb 8
Adam Fleaming posted a blog post

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 market-based…See More
Feb 6
Adam Fleaming posted a blog post

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.In many pharmaceutical organizations, the medical…See More
Jan 20
Adam Fleaming posted a blog post

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 may be termed as the least or the worst or lowest level…See More
Jan 19
Adam Fleaming posted blog posts
Jan 18
Adam Fleaming posted events
Jan 13
Adam Fleaming posted events
Dec 5, 2016
Adam Fleaming 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
Adam Fleaming 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
Adam Fleaming posted blog posts
Nov 17, 2016
Adam Fleaming 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
Adam Fleaming 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
Adam Fleaming 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

Profile Information

Where do you live (city, state, country)?
NetZealous LLC, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.
What industry do you work in?
compliance4all
What is your job title?
Event Coordinater
What company do you work for or associate with?
compliance4all
Do you currently use or recommend Personal Protective Equipment?
Yes
How did you find our online community?
through google
What best describes the role you play in the purchase of safety products?
Specify what hand protection to purchase, Use hand protection on my job, Make the actual glove purchases from a supplier, Other
If Other above, please explain.
it is very usefull

Adam Fleaming's Blog

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…

Continue

Posted on February 15, 2017 at 5:54am

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…

Continue

Posted on February 13, 2017 at 5:40am

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…

Continue

Posted on February 10, 2017 at 6:08am

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…

Continue

Posted on February 8, 2017 at 5:58am

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OSHA Training on the GHS Labeling System 2 Replies

Anyone wanting to get educated about the new OSHA training requirements on GHS labeling systems should view the free online tutorial at…Continue

Tags: hazcom, 1910.1200, labeling., training, osha

Started by Curtis Chambers, CSP. Last reply by TPC Marketing Feb 16.

Safety - A Prerequisite 10 Replies

Whether working at home or outside, to observe safety should be our pre-requisite. The employer before anything must be sure of the safety of its employees especially the ones working in mines or any…Continue

Tags: products, safety

Started by Enna Henry. Last reply by TPC Marketing Feb 16.

Reduce Risk in Workplaces 6 Replies

Although the retail industry as a whole is substantial, the costs to protect a business from injury liability can make quite the dent in profit margins. On average, the costs of employee and customer…Continue

Tags: signage, signs, workplace, tips, safety

Started by Jen Reelez. Last reply by TPC Marketing Feb 16.

Our Safety in Their Hands 15 Replies

This thought provoking workplace safety infographic features the top 5 organizations that have made the biggest impact on occupational health and safety. It features the U.S governments OSHA,…Continue

Started by Lorenzo Miguel. Last reply by TPC Marketing Feb 16.

OSHA/NEC Working Space Requirements

I joined the community because I have a question about NEC/OSHA regulations.  I'm sure I will have more :).  My question is what is the allowable distance from an MCC/control panel face to the edge…Continue

Started by Taylor Ramsey Feb 7.

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