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Adam Fleming
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  • Fremont, CA
  • United States
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21 CFR Part 11 - Compliance for Electronic Records and Signatures at Online

June 26, 2019 from 10am to 11:30am
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 26
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
Adam Fleming posted events
Nov 12, 2018

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.

Adam Fleming's Blog

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

Posted on May 16, 2019 at 7:05am 0 Comments

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

Try These 3 Things When You Face an FDA Inspection

Posted on March 11, 2019 at 8:57am 0 Comments

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

INFRARED SPECTROSCOPY Is Crucial to Your Business. Learn Why!

Posted on February 21, 2019 at 7:40am 0 Comments

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

Trial Registration and Results Reporting on ClinicalTrials.gov

Posted on February 18, 2019 at 6:22am 0 Comments

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…

Continue

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