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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

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
Monday
John Robinson posted events
Dec 7
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
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
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
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
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
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John Robinson posted events
Mar 22
John Robinson updated an event
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Process Validation General Principle and Practices Philadelphia 2018 at DoubleTree by Hilton Philadelphia Airport

May 18, 2018 from 9am to 6pm
Course "Applied Statistics for FDA Process Validation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.Overview:In Guidance for Industry Process Validation: General Principle and Practices, process validation is defined as, ""...the collection and evaluation of data, from the process design stage through commercial production.." The guidance further delineates the 'process design stage through commercial production'…See More
Mar 22
John Robinson posted events
Mar 21
John Robinson posted a blog post

Concerned about health and safety on the job?

https://globalcompliancepaneltraining.files.wordpress.com/2018/02/osha-1.jpg?w=150 150w, https://globalcompliancepaneltraining.files.wordpress.com/2018/02/osha-1.jpg?w=300 300w" sizes="(max-width: 425px) 100vw, 425px" />Are you one of those concerned about…See More
Feb 20

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

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.…

Continue

Posted on December 10, 2018 at 7:02am

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…

Continue

Posted on November 29, 2018 at 6:19am

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…

Continue

Posted on November 26, 2018 at 7:38am

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…

Continue

Posted on November 22, 2018 at 6:37am

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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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Mark Nilson posted events
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HrishikeshRam posted a blog post

Fire Protection safety Tips for Schools

While the number of school fires has decreased over recent years, they continue to be a serious risk for schools. Every year around one in twenty schools experiences a fire and nearly hour of faculty fires are started deliberately.The short effects of loss of facilities and instrumentation may be calculated, however the longer-term effects of loss of work, disruption of…See More
10 hours ago
Pro-Sapien Software posted a blog post

Pro-Sapien partners with LMS365 to offer integrated Learning Management on Office 365

Pro-Sapien Software, specialist providers of EHS software on Office 365, has announced its partnership with fellow Microsoft ISV ELEARNINGFORCE International to offer Training Management alongside Pro-Sapien’s HSEQ Innovate.ELEARNINGFORCE’s product LMS365 empowers people through learning management fit for the Modern Digital Workplace. Managers can create, distribute, and track learning courses; employees can manage their own learning schedule with progress trackers, notifications and…See More
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AI Machine Learning In Businesses How wоuld уоu define a small buѕinеѕѕ, thе number оf реrѕоnеl, thе size оf the budget, оr ѕаlеѕ?

How wоuld уоu define a small buѕinеѕѕ, thе number оf реrѕоnеl, thе size оf the budget, оr ѕаlеѕ?However you define уоur оwn ѕmаll business, it tоо can tаkе advantage оf thе AI/ …Continue

Tags: elite, crest, technologies, intelligence, Artificial

Started by emmablisa on Monday.

Distracted Driving 1 Reply

****WARNING**** Despite the fact that this is a life event portrayed by actors, it's graphic. This video should be part of…Continue

Tags: texting, fatality, safety, car, driving

Started by Wendy. Last reply by Jen McDade Dec 5.

Safety update: OSHA announces fit-test procedures 1 Reply

Fabricators as well as other workers may be required to use respirators to protect themselves from inhaling fumes, particles, or dust when performing cutting, grinding, welding, coating, or painting,…Continue

Tags: online, training, Safety, workplace, PPE

Started by Safety Training International. Last reply by Jen McDade Dec 4.

Proper guarding protects workers: Six steps to focusing on your employees' needs 1 Reply

When people think of machine guarding, usually they think of devices to protect people from the moving parts on machinery.When people think of machine guarding, usually they think of devices to…Continue

Tags: training, compliance, PPE, Training, Safety

Started by Safety Training International. Last reply by Jen McDade Dec 4.

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