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Adam Fleming
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  • Fremont, CA
  • United States
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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
Adam Fleming posted events
Jul 15
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
Adam Fleming posted events
May 20
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
Adam Fleming posted events
Mar 25
Adam Fleming posted a blog post

Try These 3 Things When You Face an FDA Inspection

Nothing perhaps rattles a regulatory professional as much as an FDA inspection! It can send the regulatory professional who is in charge of compliance into panic mode for a variety of reasons. As the one who faces the heat from the FDA directly, the regulatory professional is answerable to the FDA, most of whose questions are challenging and awkward. If anything goes wrong at any stage, it is the company that suffers.Yet, an FDA inspection need not be the most nerve-wracking event of a…See More
Mar 11
Adam Fleming posted a blog post

INFRARED SPECTROSCOPY Is Crucial to Your Business. Learn Why!

Near-Infrared Spectroscopy, NIR or NIRS, is considered a superior method assay to traditional ones, which are destructive and also reduce the number of doses for sale. It overcomes these drawbacks by being both rapid and nondestructive, which helps it respond to the pressures in the pharma industry for generating more and more data, which leads to more assays that bring these inevitable downsides.In being responsive to the physical and chemical environment of…See More
Feb 21
Adam Fleming posted events
Feb 21
Adam Fleming posted a blog post

Trial Registration and Results Reporting on ClinicalTrials.gov

The Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11) clarifies and expands the regulatory requirements and procedures for submitting registration and results information for certain clinical trials to ClinicalTrials.gov, in accordance with Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801).The Final Rule has been in effect since January 18, 2017. The International Committee of Medical Journal Editors (ICMJE) requires trial…See More
Feb 18
Adam Fleming posted a blog post

What do Your Customers Really Think About Your Complaint Handling?

Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, is organizing a webinar on the topic, “Complaint Handling” on February 6. Peggy J. Berry, President & CEO at Synergy Consulting, will be the speaker at this webinar.Please visit http://bit.ly/2GFGiXr to enroll for this webinar.—————————————————————————————————————A complaint says a lot about a product. It helps the manufacturer to reflect on where it…See More
Feb 15
Adam Fleming posted a blog post

How to Find the Right “DIETARY SUPPLEMENTS” for Your Specific Product (Service)

Compliance4All, a leading provider of professional training for all areas of regulatory compliance, is organizing a 90-minute webinar on the topic, “Dietary Supplements CGMPS – 21 CFR 111 Compliance”, on February 5. John E. Lincoln, a medical device and Regulatory Affairs consultant, will be the expert at this webinar.Please visit http://bit.ly/2DIk8lf to enroll for this webinar.————————————————————————————————————-How to find the right dietary supplements…See More
Jan 30
Adam Fleming posted events
Jan 25
Adam Fleming posted events
Dec 11, 2018
Adam Fleming posted a blog post

You will get Great Results from your Data with Excel PowerPivot and PowerQuery

If you work with data, you’re likely already familiar with common frustrations with Microsoft Excel like size limitations and manually entering data from multiple sources. Luckily there are two Microsoft tools- PowerPivot and PowerQuery-that solve ALL of these issues, right inside Excel.In today’s world, there is tons of data to manage. Data is coming from many different sources. It is very important to be able to process that data quickly and then summarize it into meaningful information. Many…See More
Dec 5, 2018
Adam Fleming posted a blog post

How to Turn Your Cyber Incident Response (Plans from Blah) into Fantastic?

Let us face it. A cyber incident could happen to any organization that has a computer system that is connected to the Net. Well, the next question is, does such an organization exist? Almost no organization in today’s world, no matter of what size and which part of the world it could be in, can function without a cyber system. So, this means that simply any organization is vulnerable to a cyberattack and every organization should have a cyber incident response plan in place.The simplest way to…See More
Nov 16, 2018

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

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…

Continue

Posted on August 12, 2019 at 8:35am

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…

Continue

Posted on May 16, 2019 at 7:04am

Try These 3 Things When You Face an FDA Inspection

Nothing perhaps rattles a regulatory professional as much as an FDA inspection! It can send the regulatory professional who is in charge of compliance into panic mode for a variety of reasons. As the one who faces the heat from the FDA directly, the regulatory professional is answerable to the FDA, most of whose questions are challenging and awkward. If anything goes wrong at any stage, it is the company that suffers.

Yet,…

Continue

Posted on March 11, 2019 at 8:57am

INFRARED SPECTROSCOPY Is Crucial to Your Business. Learn Why!

Near-Infrared Spectroscopy, NIR or NIRS, is considered a superior method assay to traditional ones, which are destructive and also reduce the number of doses for sale. It overcomes these drawbacks by being both rapid and nondestructive, which helps it respond to the pressures in the pharma industry for generating more and more data, which leads to more assays that bring these inevitable…

Continue

Posted on February 21, 2019 at 7:40am

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Morgan Franklin posted a blog post

Benefits of First Aid Training in the Workplace

It is the legal duty of employers to have adequate first aid procedures in place. As stated by the UK Government Health and Safety Executive (HSE), this includes an obligation to assess risks and to take appropriate action to control the risks, and to also provide suitable facilities and safety equipment. As well as having a fully stocked first aid kit, businesses also need to have appointed first aiders who are trained in helping…See More
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Workplace safety for workers other than your own 3 Replies

Do your workplace/traffic safety plans include safety measures for workers who are not your own employees? Do they take into account the safety of those who will be - or could be - at your workplace,…Continue

Tags: emt, paramedics, emergency, occupational, health

Started by John Petropoulos Memorial Fund. Last reply by Paul Lancaster May 28.

Imagine a technology which is an artificial muscle and is integrated into textiles...

Such a smart textile has huge application potential and can support people in many different ways. The garment would use haptic feedback (i.e. the use of touch to guide the user) or could serve as a…Continue

Started by Ulla Siegel May 28.

Green Smart Technical 800+ Turnkey Projects in UAE – Rope Access Company in Dubai

Green smart is an ISO 9001: 2015 QMS, OHSAS 18001: 2017 OHSMS, ISO 14001: …Continue

Tags: window, cleaning, services, facade, companies

Started by Manikandan Apr 23.

What % of Dollars should be bugeted for All Safety Training for a "Heavy Equipment Road Construction" company with 100 employees? 1 Reply

I have been at a Highway and Road Construction company for six months. I am developing a (first) complete training program. I am the 1st full time safety hire for this company. I need to develop a…Continue

Started by JTurpening. Last reply by Jen McDade Feb 19.

Technology and Safety 1 Reply

What are the most useful tools to have at your fingertips? -Toolbox Talks-JSA-JHA-Daily Reports, etc. What is falling through the cracks that could be an easy fix? Safety Managers, Coordinators and…Continue

Tags: safety

Started by Drew stone. Last reply by Jen McDade Feb 15.

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