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John Robinson
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  • Fremont, CA
  • United States
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Risk Management Solutions

Risk is defined as the potential hazard, harm or side effect of an activity. Almost all activities come with some or another form of risk, which needs to be mitigated or eliminated. Risk management…Continue

Tags: risk, Banking, management, healthcare, Process

Started Oct 17, 2017

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.

 

John Robinson's Page

Latest Activity

John Robinson posted a blog post

eCTD Submissions of IND-NDA to the US FDA, EU and Canada

The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies.  Reformatting for multiple submissions is substantially limited.  The CTD has improved the regulatory review processes and enabled implementation of good review practices. The…See More
21 hours ago
John Robinson posted a blog post

Effective Technical Writing in the Life Sciences

Technical writing and its role within the life sciences. Technical writers produce a variety of technical documents that are required to manage and direct regulated operations and to meet regulatory requirements. We will spend some time in this webinar discussing those document types, their importance, and the consequences of the messages are unclear or misunderstood.After setting the stage for this content, we delve into the writing process beginning with the audience and how the audience must…See More
Jan 9
John Robinson posted a blog post

How the FDA interprets advertising and promotion in principle and in fact

If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue. Advertising and promotion for devices is weak and lacks legal clarity. For drugs, the regulations are prescriptive and guidance documents clamp down on nuances. Marketing and regulatory affairs departments must collaborate to avoid the hammer and penalties of FDA. The roadblock, however is that marketing managers and regulatory affairs managers rarely reach common ground and are loathe…See More
Jan 7
John Robinson posted a blog post

6-Hour Virtual Seminar on FDA's Software Monsters

The complexity and vulnerability of software is expanding exponentially, so fast that Congress removed some device software from FDA’s jurisdiction.  The remaining software regulated by FDA presents a degree of a risk to health that creates a public health concern.  Part of that risk involves the intentional activity that can conflict, intrude or destroy software.  The problems are taking center stage in the “healthcare software” dialogue.  What issues can compromise or defeat the functional…See More
Jan 2
John Robinson posted a blog post

Nutrition Facts labels of pure maple syrup and honey

FDA Commissioner, Scott Gottlieb, has announced a major overhaul of the FDA’s update to the Nutrition Facts label on products. This overhaul, the first in nearly twenty years, is aimed at empowering consumers by furnishing information on Nutrition Facts labels pure maple syrup and honey that ensures greater accuracy and is more science-based. With this, the FDA wants to help consumers make more informed and healthier choices.This update to the Nutrition Facts label has incorporated the latest…See More
Dec 14, 2018
John Robinson posted a blog post

What are the FDA's Process Validation requirements?

Process Validation (PV), according to the FDA, is collecting and assessing data right from the design stage till the production stage. PV is set out for all the stages of production for a product in the FDA-regulated industries. The core purpose of PV is to establish scientific proof that any process being employed has the capability of delivering quality products consistently.The FDA’s process validation requirements are set out in its general principles of Process Validation. Starting from…See More
Dec 10, 2018
John Robinson posted events
Dec 7, 2018
John Robinson posted a blog post

Will smart devices be the smartphones of the medical device industry?

This is how the current-day situation of administering medical care runs: in the event of a medical need, the patient or someone attached to her is expected to sense the difficulty and call up the medical center to which the patient is attached. Help arrives after this is done. The medical practitioner may come over and attend to the patient at her location if the situation permits. Or else, the ambulance has to be called. All this has to done during what is called the Golden Hour: the most…See More
Nov 29, 2018
John Robinson posted a blog post

A Process Approach to Quality Management Systems

ISO 13485:2016 describes a process approach to Quality Management Systems for Medical Devices.  This 6 -hour virtual seminar will help you to understand the process approach and develop an effective Quality Management System (QMS) for Medical Device Companies.  A well-structured QMS meets the requirements of the Quality System Regulations and is both effective and efficient.  The regulations require that manufacturers “establish and maintain a quality system that is appropriate for the specific…See More
Nov 26, 2018
John Robinson posted a blog post

Dramatic changes expected into medical device regulations

A slew of updates to existing medical device and diagnostics (MD & D) regulations is on the cards. Medical device and diagnostics is a field that keeps changing every now and then. But what is different this time is that the industry is up against a series of updates, not just from one regulatory agency, but from a multitude of agencies and standards: FDA, EMA, ISO 13485 and ISO 11607, the last of which is about packaging for terminally sterilized medical devices.Nature of changes to the…See More
Nov 22, 2018
John Robinson posted a blog post

FDA Scrutiny of Promotion and Advertising Practices

If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue. Advertising and promotion for devices is weak and lacks legal clarity. For drugs, the regulations are prescriptive and guidance documents clamp down on nuances. Marketing and regulatory affairs departments must collaborate to avoid the hammer and penalties of FDA. The roadblock, however is that marketing managers and regulatory affairs managers rarely reach common ground and are loathe…See More
Nov 20, 2018
John Robinson posted a blog post

Tougher Import Rules for FDA Imports in 2018

FDA and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of import information and adherence to government procedures. Firms that fail to understand and properly execute an import and export program find their shipments delayed, detained or refused. As of December 2016, FDA and CBP officially implemented the Automated Commercial Environment (ACE) entry filing system. You either meet ACE requirements or face entry refusals…See More
Nov 19, 2018
John Robinson posted events
Oct 30, 2018
John Robinson posted events
Aug 17, 2018
John Robinson posted events
Jul 13, 2018
John Robinson posted events
Jul 2, 2018

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
What best describes the role you play in the purchase of safety products?
Specify what hand protection to purchase

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John Robinson's Blog

eCTD Submissions of IND-NDA to the US FDA, EU and Canada

The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies.  Reformatting for multiple submissions is substantially limited.  The CTD has improved the regulatory review processes and enabled implementation of good review…

Continue

Posted on January 18, 2019 at 5:16am

Effective Technical Writing in the Life Sciences

Technical writing and its role within the life sciences. Technical writers produce a variety of technical documents that are required to manage and direct regulated operations and to meet regulatory requirements. We will spend some time in this webinar discussing those document types, their importance, and the consequences of the messages are unclear or misunderstood.

After setting the stage for this content, we delve into the writing process beginning with the audience and how the…

Continue

Posted on January 9, 2019 at 6:44am

How the FDA interprets advertising and promotion in principle and in fact

If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue. Advertising and promotion for devices is weak and lacks legal clarity. For drugs, the regulations are prescriptive and guidance documents clamp down on nuances. Marketing and regulatory affairs departments must collaborate to avoid the hammer and penalties of FDA. The roadblock, however is that marketing managers and regulatory affairs managers rarely reach common ground and are…

Continue

Posted on January 7, 2019 at 7:28am

6-Hour Virtual Seminar on FDA's Software Monsters

The complexity and vulnerability of software is expanding exponentially, so fast that Congress removed some device software from FDA’s jurisdiction.  The remaining software regulated by FDA presents a degree of a risk to health that creates a public health concern.  Part of that risk involves the intentional activity that can conflict, intrude or destroy software.  The problems are taking center stage in the “healthcare software” dialogue.  What issues can compromise or defeat the…

Continue

Posted on January 2, 2019 at 5:58am

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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

Mark Nilson posted events
19 hours ago
John Robinson posted a blog post

eCTD Submissions of IND-NDA to the US FDA, EU and Canada

The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies.  Reformatting for multiple submissions is substantially limited.  The CTD has improved the regulatory review processes and enabled implementation of good review practices. The…See More
21 hours ago
Training Doyens posted an event
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Live Webinar on How to Hire, Retain, and Grow a Diverse & Inclusive Workforce at 26468 E Walker Dr, Aurora, Colorado 80016

February 19, 2019 from 1pm to 2pm
OVERVIEWSTOP - Do not put out another hiring notice until you fully consider the ramifications of diversity and inclusion in the workplace.  Why is this important? First, if you have diverse customers, those customers will relate to the diverse employees helping them or selling to them. Second, to avoid a homogeneous culture where people want to fit in so desperately that…See More
yesterday
swethakumar posted a blog post

Fire Safety Tips For the WorkPlace

Fires are a preventable catastrophe which will cause many thousands of greenbacks harm, loss of production, loss of jobs and loss of lives.When controlled properly, the hearth is one in all our greatest allies within the geographic point, a quite helpful partner of trade. once it’s uncontrolled but, it will become our worst and most feared enemy.There are several easy things that you simply as an employee will do to minimize the danger of fireplace within the geographic point. Here are some…See More
yesterday

Forum

Important of Warning sign 1 Reply

Warning sign is a type of traffic sign that guide a hazard ahead on the road. Having proper warning sign on the road provide a healthy environment.Continue

Tags: Signs, Workplace, Safety, Sign, Warning

Started by healthandsafetysigns. Last reply by Jen McDade on Monday.

Workers paticipation in safety management 2 Replies

Workers paticipation in safety management is the aspect which is required to be implemented in the OHSAS 18001 2007 version. , I invite our experience community members to share their views on the…Continue

Tags: management, safety, in, paticipation, Workers

Started by SafetyRaja. Last reply by Tara safe Dec 27, 2018.

How to improve safety culture of factories 4 Replies

How to improve safety culture of factories having mostly contract and casual ever changing workers for whom training and monitoring both are major issues. Such qorkers are mainly meeting accidents in…Continue

Started by Harkant Dave. Last reply by Jen McDade Dec 24, 2018.

[General Industry] What is your workplace's policy on headphones? Working on one currently. 1 Reply

I have been tasked to create a headphones (and cell phone) policy for my employer. I am relatively new to this company, but so far they've let everyone listen to headphones and mess around with their…Continue

Tags: general, industry, distraction, music, phone

Started by Kyle C. Johnson. Last reply by Jen McDade Dec 19, 2018.

Biggest Challenge? 5 Replies

As a distributor of safety supplies, as a webmaster who is trying to sell safety supplies online, one of my main goals is to try to provide value above and beyond just selling supplies and product.So…Continue

Started by Safetyguy08. Last reply by Jen McDade Dec 18, 2018.

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