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Adam Fleming
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  • Fremont, CA
  • United States
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Adam Fleming posted events
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Feb 14
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Feb 6
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Jan 22
Adam Fleming posted a blog post

The Dietary Supplement cGMP rule (21 CFR part 111)

FDA regulates both finished dietary supplement products and dietary ingredients.FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products.Under the Dietary Supplement Health and Education Act of 1994 (DSHEA):Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded.That means that these firms are responsible for evaluating the…See More
Jan 22
Adam Fleming posted events
Jan 6
Adam Fleming posted events
Dec 10, 2019
Adam Fleming posted a blog post

Pharmaceutical Drug Registration in China

Surely, no pharma company can overlook the world’s second largest pharmaceutical market: China. Its huge population has a high demand for healthcare products. In tune with this growing requirement, many changes have been brought in into the healthcare system, which is now more attractive than ever to foreign companies that want to bring in new products to market.On the one hand, factors such as incentives, such as market exclusivity and acceptance of foreign clinical trial data, are too good to…See More
Oct 9, 2019
Adam Fleming posted a blog post

Facts about deviation investigations everyone should know

Focus on how to avoid the pitfalls that may occur during FDA inspections and help eliminate 483 observations. Learn how to identify and avoid potential pitfalls during deviation investigations.One of the foremost common authority 483 and Warning Letter citations continues to be inadequate investigations. The authority uses the investigation reports and investigation trends to spot potential quality issues altogether areas of the corporate. Ultimately, inadequate investigations will result in…See More
Aug 12, 2019
Adam Fleming posted events
Jul 15, 2019
Adam Fleming posted an event
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21 CFR Part 11 - Compliance for Electronic Records and Signatures at Online

June 26, 2019 from 10am to 11am
Overview: This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records as described in the FDA Guidance will be explained.FDA regulated companies want to transition to electronic records for economy and efficiency. FDA, because of its concern for patient safety, wants to prevent electronic records from being…See More
Jun 25, 2019
Adam Fleming posted events
May 20, 2019
Adam Fleming posted a blog post

FOOD SUPPLY CHAIN – An Incredibly Easy Method That Works For All

A few sciences are changing our lives in more ways than we could have imagined a few decades ago. Artificial Intelligence (AI) is at the forefront of these. Although a few decades old, it has received a huge boost of late with the emergence of the cloud, which is set to help it overcome one of its biggest stumbling blocks, namely space, the added power of computing, and wider methods of algorithms.While one would like to associate AI with robotics, this is taking a very limited view of a topic…See More
May 16, 2019

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 Fleming's Blog

3-Hour Virtual Seminar on FDA's section 804 Drug and 801(d)(1)(B) Biologic Importation Programs

This presentation outlines the two proposed pathways through which HHS and FDA will allow for the importation of certain drugs originally intended for non-US markets.

Notably, both pathways rely on parties other than the federal government-such as states, wholesalers, pharmacists, and manufacturers-to demonstrate that eligible drugs can be imported into the US safely and with the required cost savings.

Posted on February 17, 2020 at 6:42am

Metrology: Statistical Analysis of Measurement Uncertainty

The webinar begins with an examination of the fundamental vocabulary and concepts related to metrology. Topics include: accuracy, precision, calibration, and "uncertainty ratios".

Several of the standard methods for analyzing measurement variation are then described and explained, as derived from AIAG's Measurement System Analysis reference book. The methods include: Gage R&R (ANOVA method, for 3 gages, 3 persons, 3 replicates, and 10 parts), Gage Correlation (for 3 gages), Gage…

Continue

Posted on February 17, 2020 at 6:41am

Metrology: Statistical Analysis of Measurement Uncertainty

The webinar begins with an examination of the fundamental vocabulary and concepts related to metrology. Topics include: accuracy, precision, calibration, and "uncertainty ratios".

Several of the standard methods for analyzing measurement variation are then described and explained, as derived from AIAG's Measurement System Analysis reference book. The methods include: Gage R&R (ANOVA method, for 3 gages, 3 persons, 3 replicates, and 10 parts), Gage Correlation (for 3 gages), Gage…

Continue

Posted on February 17, 2020 at 6:41am

Change Management System

The presentation will focus on FDA responses to failures in Change Management.

The presentation shall describe how FDA expects firms to establish change management, the sources of change management, the outcomes from change management, and timely outcomes. We will cover some suggestions and Do's and Dont's.

Posted on February 17, 2020 at 6:40am

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Nikolas Wells posted a blog post

Morganite: A Beautiful Pastel Pink Gemstone

What is Morganite?Morganite is a lovely pastel gem that is little known and underrated. This beautiful pink gem is seldom seen marketed in basic precious jewelry shops. Morganite is a light to pastel pink member of the beryl family. While it is not a typical gem, it is a gemstone that is much in demand. Due to its light color, it is rarely seen in little sizes, yet fortunately, several pink Beryl crystals are commonly average to large; therefore, good-sized Morganite gems are reduced. As it…See More
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swethakumar posted a blog post

IOSH Managing Safely Course in Cochin

IOSH Managing Safely is a basic risk management certificate in health and safety and it is accredited by the Institution of Occupational Safety and Health (IOSH) which is one of the largest HSE awarding bodies across the world.Read more about IOSH Course…Safety…See More
11 hours ago
Nishana Nibha posted a blog post

How To Make Dental Procedures Without Any Insurance?

Taking the campaign to visit your dentist near me no insurance for a check-up, a few needed radiographs and also possibly a cleansing is the most effective path to take. If you haven't gone in a while, the initial consultation may be a lot pricier. But once the preliminary appointment is complete, your return check-ups (whether they are 6 months, 9 months or yearly, as determined in between you and also your dental practitioner) are a…See More
11 hours ago
David Warner posted a discussion

What to do when Garmin express installer won’t open?

Garmin express is a tool that allows GPS owners to update their GPS device. I am utilizing it for a couple of months with no technical glitch. Last week, I tried to update my GPS software and maps. When I started Garmin express, I observed that it was the latest version. All things went normal. When I tried to open Garmin express installer, but I got many technical problems to open it. Till now, I have no…See More
12 hours ago

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What to do when Garmin express installer won’t open?

Garmin express is a tool that allows GPS owners to update their GPS device. I am utilizing it for a couple of months…Continue

Started by David Warner 12 hours ago.

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BKF File Recovery Solution

You need to understand what makes a BKF file corrupted such as virus infection, hard disk failure, sudden power failure, missing catalog file, software malfunction, CRC failed. So there is no other…Continue

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