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John Robinson
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  • Fremont, CA
  • United States
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Handheld Medical Devices - The Next Revolution in Healthcare?
1 Reply

IntroductionHandheld devices are light-weight and compact devices that can be operated holding it in your hands. Handheld medical devices are available for medical information, used by physicians,…Continue

Tags: device, healthcare, fda, training, devices

Started this discussion. Last reply by Arnold Brame Aug 16, 2014.

 

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John Robinson posted blog posts
yesterday
John Robinson posted a blog post

Tips and Suggestions on interacting with FDA Officials and Premarket Approval (PMA)

Preparing premarket submissions that win regulatory approval is a complex task, even for the most seasoned professional in the medical devices industry. This is because of the highly stringent nature of the regulatory approval pathways, namely the Premarket Approval (PMA) process and FDA regulatory 510(k)…See More
Tuesday
John Robinson posted events
Apr 21
John Robinson posted blog posts
Apr 21
John Robinson posted a blog post

Rising in one’s career through leadership management

Being a manager is an exercise in continuity. One does not become a manager and stop there. It is important to be, than to become managers. This means that management is a journey, not a destination. Because of this, continuous improvement is needed into this discipline from time to time.Leadership management is needed to improve both the manager’s own self, and with it, the growth of the organization. Leadership management may be defined as the means by which one identifies, manages and…See More
Apr 19
John Robinson posted a blog post

FDA and EU requirements on data integrity and implementation

Data integrity and its implementation in cGMP records are major requirements from the FDA. The FDA considers these as important requirements to ensure the integrity of data in these records. The FDA’s, as well as the EU’s requirements are set out for ensuring both data integrity and its implementation are set out in 21 CFR…See More
Apr 17
John Robinson posted a blog post

Applied Statistics for FDA Process Validation 2017

The pharmaceutical industry considers Applied Statistics for FDA Process Validation to be of very high importance. In 2011, the FDA set out this guidance for the industry. as part of this guidance, called “Process Validation: General Principles and Practices”, which sets the framework for Process Validation in the pharmaceutical industry, any organization in the pharmaceutical industry has to set up a three-stage process.These are the three stages:       I.           Process…See More
Apr 12
John Robinson posted events
Mar 10
John Robinson posted events
Feb 21
John Robinson posted events
Feb 20
John Robinson posted a blog post

How to build a complete Safety, Health & Environment Management System through Standards & Practices 2017

 Course "How to build a complete Safety, Health & Environment Management System through Standards & Practices" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full…See More
Feb 15
John Robinson posted a blog post

The Design History File (DHF), the Technical File (TF) and the Design Dossier (DD)

The Design History File (DHF), the Technical File (TF) and the Design Dossier (DD) are core regulatory documents for a medical device. This is how one can understand the central difference between them: the Design History File (along with Design Control), is the most important among the regulatory documents that the FDA requires for medical devices, while the Technical File and Design Dossier are documents that serve the same purpose, however, within the EU’s regulatory body, the Medical Device…See More
Feb 13
John Robinson posted a blog post

Preparing premarket submissions that win regulatory approval

Preparing premarket submissions that win regulatory approval is a complex task, even for the most seasoned professional in the medical devices industry. This is because of the highly stringent nature of the regulatory approval pathways, namely the Premarket Approval (PMA) process and FDA regulatory 510(k)…See More
Feb 10
John Robinson posted blog posts
Feb 7
John Robinson posted a blog post

Quality is everything for a product or service

Quality is everything for a product or service. Quality is defined in different ways. One of the well-known definitions of Quality is the ability of a product or service to reach expected levels of excellence. This is a simple theoretical definition. In practice, though, Quality is a highly painstaking area of activity that is necessary across all functions of all industries. If a product does not meet its quality requirements or criteria, it is doomed to failure.An organization can understand…See More
Feb 3
John Robinson posted events
Feb 3

Profile Information

Where do you live (city, state, country)?
Fremont
What industry do you work in?
Pharma
What is your job title?
Event Coordinator
What company do you work for or associate with?
GlobalCompliancePanel
Do you currently use or recommend Personal Protective Equipment?
Not Sure
How did you find our online community?
Through Google
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Specify what hand protection to purchase

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John Robinson's Blog

Article on “A Tour of the FDA”

Posted on April 27, 2017 at 5:50am

Good Manufacturing Practices are essential for ensuring quality

Key Takeaway:

GMPs are critical for the manufacture and distribution of foods, drugs and other pharmaceutical products. These need to be implemented diligently by organizations that are involved in these products.

Quality is a great concern for a manufacturer and consumer of any product. To ensure that quality is maintained across a variety of products ranging from foods to pharmaceutical products; a few guidelines are required. These guidelines…

Continue

Posted on April 26, 2017 at 8:06am

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At 4:23pm on February 9, 2012, Ken Oswald said…
Welcome to the community. I hope you find it is a wonderful resource full of information through our blogs, networks, forums and groups. Again welcome.

Ken O
 
 
 

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Latest Activity

Alex posted a blog post

4 eco-friendly safety essentials to help save the world

The health and safety sector and the green sector now thankfully meet with a selection of products that are effective in preventing harm to workers, while also benefitting the environment. Such developments are important factors in the modern workplace, which wants to keep employees safe and now also wants to reduce its carbon…See More
12 hours ago
Adam Fleaming posted a blog post

The art of writing effective audit observations

Audits are a means of evaluating operations and other functions of an organization. ISO 19011:2011 Guidelines for Auditing Management Systems describes audits as a process used for gathering the evidence of verifiable documents and map their suitability, alignment and fulfilment with the company’s policies and procedures.An audit is an important tool that helps organizations to analyze opportunities, implement best practices, and assess all the important factors in a business, such as risks,…See More
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John Robinson posted blog posts
yesterday
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Forum

What's your favorite motivational/safety quote? 98 Replies

Favorite Motivational Quote: If you want something, you'll find a way - If not, you'll find an excuse.Favorite Safety Quote: Don't learn safety by accident!Continue

Started by Michelle Sears. Last reply by David R Snell on Wednesday.

Feedback on a injury prevention product we're building.

Hi everyone!For full transparency ill tell you a little about myself and what I hope to accomplish. My name is Zuber and I'm an engineering student who founded a startup helping to build wearable…Continue

Tags: product, prevention, injury, back, safety

Started by Zuber Ahmed on Monday.

Best overall personal safety book? 1 Reply

What do you think is  the best all-in-one book out there for optimizing personal safety and the safety of one's family?  Right now I have …Continue

Started by David R Snell. Last reply by David R Snell Apr 21.

Fire codes for residential buildings

Hi,Can anybody kindly give me a hint how to find Fire Codes for residential buildings in different cities in the United States?Continue

Started by Darren Asad Apr 14.

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 Mar 24.

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