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

Establishing Latest Quality Systems in medical device and pharmaceutical industries

Establishing Quality Systems is one of the central aspects of a medical device and/or pharmaceutical organization. Establishment of Quality Systems is also a regulatory requirement, as set out by the FDA and the ISO.The process of establishment of Quality Systems for FDA-regulated medical devices industries is set out in 21 CFR Part 820. Further, the ISO has its standard for how to establish Quality Systems in medical devices industries –the ISO 13485 standard –which has to be implemented as…See More
12 hours ago
Adam Fleaming posted a blog post

Right now Medical device hazard analysis, the core of medical devices

Medical device hazard analysis is of vital importance to a medical device. Medical device hazard analysis is at the heart of medical devices because if the device is not analyzed thoroughly for the hazard, or danger, that it poses, it is likely to cause problems of any kind to the user. Many a time, it becomes a matter of life and death. This is why medical device hazard analysis is of foremost importance.So, what is medical device hazard analysis? Medical device hazard analysis may be defined…See More
yesterday
Adam Fleaming posted a blog post

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?This is simply not the case. Quality and compliance are built into a medical device…See More
Friday
Adam Fleaming posted a blog post

Today’s Pre control and Statistical Process Control (SPC)

Pre control and Statistical Process Control (SPC) are key tools for determining the process that goes into a product.SPC is a key ingredient of Quality. It is an important step in reducing nonconformities and defects in any manufacturing process. SPC charts help to detect assignable causes of a process change in a timely fashion. SPC helps to identify root causes and take corrective actions before the development of the product has reached such a stage that carrying changes out is neither…See More
Mar 22
Adam Fleaming posted events
Mar 22
Adam Fleaming posted blog posts
Mar 16
Adam Fleaming 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
Adam Fleaming 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
Adam Fleaming 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
Adam Fleaming 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
Adam Fleaming posted events
Feb 24
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

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

Establishing Latest Quality Systems in medical device and pharmaceutical industries

Establishing Quality Systems is one of the central aspects of a medical device and/or pharmaceutical organization. Establishment of Quality Systems is also a regulatory requirement, as set out by the FDA and the ISO.

The process of establishment of Quality Systems for FDA-regulated medical devices industries is set out in 21 CFR Part 820. Further, the ISO has its standard for how to establish Quality Systems in medical devices industries –the ISO 13485 standard…

Continue

Posted on March 28, 2017 at 9:06am

Right now Medical device hazard analysis, the core of medical devices

Medical device hazard analysis is of vital importance to a medical device. Medical device hazard analysis is at the heart of medical devices because if the device is not analyzed thoroughly for the hazard, or danger, that it poses, it is likely to cause problems of any kind to the user. Many a time, it becomes a matter of life and death. This is why medical device hazard analysis is of foremost importance.…

Continue

Posted on March 27, 2017 at 8:31am

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?…

Continue

Posted on March 24, 2017 at 6:31am

Today’s Pre control and Statistical Process Control (SPC)

Pre control and Statistical Process Control (SPC) are key tools for determining the process that goes into a product.

SPC is a key ingredient of Quality. It is an important step in reducing nonconformities and defects in any manufacturing process. SPC charts help to detect assignable causes of a process change in a timely fashion. SPC helps to identify root causes and take corrective actions before the development of the product has reached such a stage that…

Continue

Posted on March 22, 2017 at 6:04am

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Latest Activity

Adam Fleaming posted a blog post

Establishing Latest Quality Systems in medical device and pharmaceutical industries

Establishing Quality Systems is one of the central aspects of a medical device and/or pharmaceutical organization. Establishment of Quality Systems is also a regulatory requirement, as set out by the FDA and the ISO.The process of establishment of Quality Systems for FDA-regulated medical devices industries is set out in 21 CFR Part 820. Further, the ISO has its standard for how to establish Quality Systems in medical devices industries –the ISO 13485 standard –which has to be implemented as…See More
12 hours ago
Adam Fleaming posted a blog post

Right now Medical device hazard analysis, the core of medical devices

Medical device hazard analysis is of vital importance to a medical device. Medical device hazard analysis is at the heart of medical devices because if the device is not analyzed thoroughly for the hazard, or danger, that it poses, it is likely to cause problems of any kind to the user. Many a time, it becomes a matter of life and death. This is why medical device hazard analysis is of foremost importance.So, what is medical device hazard analysis? Medical device hazard analysis may be defined…See More
yesterday
Scott V posted a discussion

OSHA and Machine Guard Door Safety???

We have what we feel is not a unique situation and were wondering if anyone might of run across this challenge and know more about the requirements.  We are building a small machine system that includes some pneumatic components and some heated plates inside a small guard system.  We include emergency stops on the machine and if they are actuated it removes all electric current and dumps all air pressure from the machine.  We have several electrically interlocked doors that can be opened to…See More
Friday
Profile IconJayakumar, Scott V and Scott Effinger joined Online Safety Community
Friday

Forum

OSHA and Machine Guard Door Safety???

We have what we feel is not a unique situation and were wondering if anyone might of run across this challenge and know more about the requirements.  We are building a small machine system that…Continue

Tags: electric, osha, air, door, interlocked

Started by Scott V on Friday.

OSHA 500 and 510 9 Replies

Hey Guys,How many of you have taken the 510 and 500 OSHA Trainer course? I am thinking about taking these 2 classes and become an OSHA trainer for my company. What are your guys thoughts on the…Continue

Started by Alfred Good. Last reply by Mymic Mar 15.

OSHA Training, Standards & Best Practices 3 Replies

Get trained on OSHA regulations affecting your industry through online webinars, learn the best practices, and download quality standards, checklists and news articles. Listen to experts on best…Continue

Tags: Webinar, Training, 2011, OSHA, compliance

Started by admin. Last reply by Mymic Mar 15.

FORKLIFT TRAINING CLASSES 21 Replies

Any ideas on how to make Forklift Training Classes more interesting and fun?

Started by Marcia Whatley. Last reply by Mymic Mar 15.

Our Safety in Their Hands 16 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 Mymic Mar 15.

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