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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.

 

John Robinson's Page

Latest Activity

John Robinson posted blog posts
10 hours ago
John Robinson posted a blog post

Implementing ICH guidelines-compliant validation

Professionals in the field of statistical analysis need to possess clarity on understanding and interpreting statistical concepts used to investigate quantitative ICH Guidelines, such as:Analytical methods validationProcedures and acceptance criteria in calibration limits…See More
Monday
John Robinson posted a blog post

An integrated approach is needed for Complaints Handling, Adverse Event Reporting, and Recalls

The fact that medical device manufacturers work and operate in various regulatory systems whose requirements are different and not always consistent with each other is recognized and empathized by the new ISO version, the ISO…See More
Friday
John Robinson posted a blog post

Training and Development is a highly developed and evolved, broad body of knowledge. Many employees place themselves at a disadvantage vis-à-vis their colleagues in the absence of the right professio…

Training and Development is a highly developed and evolved, broad body of knowledge. Many employees place themselves at a disadvantage vis-à-vis their colleagues in the absence of the right professional training and development. If employees have to consistently close gaps in their learning, they need to keep upgrading their knowledge and skills. They should also use training…See More
Jul 19
John Robinson posted a blog post

The ways of applying ISO 14971, IEC 62304 and IEC62366-1 to medical device software

Diligence, complete and proper examination and assessment of the gaps, and correction of the gaps right from the very start of product development are the core characteristics that need to go into implementing risk management of software used in medical devices.These are the reasons for it:Lack of proper and complete implementation and gaps in them lead to major drawbacks such as production delays or deficiencies.…See More
Jul 13
John Robinson posted a blog post

Do human factors matter in medical devices?

Is there a relationship between medical devices and human factors? This is a question that is seriously worth exploring. According to the ANSI/AAMI HE75:2009 document, human factors is an endeavor for optimizing the production of devices, systems, and many others concerned with them through the use of emotional, intellectual, physical and sensory forms of…See More
Jul 12
John Robinson posted events
Jul 11
John Robinson posted a blog post

Knowing what to expect in a HIPAA audit is the key to passing it

Healthcare professionals have to mandatorily carry out HIPAA audits in a way that satisfies the regulatory authorities. This needs a thorough understanding of the exact meaning and import of words contained in HIPAA. They also need to get a grasp of the purpose and intent conveyed in HIPAA’s language. This is absolutely essential for both the Covered…See More
Jul 7
John Robinson posted a blog post

Safety Management and OSHA Compliance

Why is Occupational Safety and Health Administration (OSHA) compliance necessary? For a simple reason: OSHA compliance is the surest legal way of ensuring safety at the workplace. Safety management and OSHA compliance go hand in hand and are deeply connected to and intertwined with each other. Safety management is at the core of OSHA and is the very…See More
Jun 28
John Robinson posted blog posts
Jun 27
John Robinson posted blog posts
Jun 14
John Robinson posted events
Jun 12
John Robinson posted a blog post

Quality by Design using Design of Experiments

The Q8, which is the ICH guidance document on pharmaceutical development, requires a drug product to meet its intended product performance as well as the needs of patients. A drug product is encouraged to adapt a systematic approach for pharmaceutical development in accordance with the steps defined by Quality by Design (QbD) principles, even though the…See More
Jun 8
John Robinson posted blog posts
Jun 6
John Robinson posted a blog post

Four years of the EU’s Cosmetics Product Regulation

It has been four years since the EU’s Cosmetics Product Regulation (Regulation EC No. 1223/2009), initiated in December 2009, became operational in July 2013. This regulation was considered path breaking when it was introduced because of its comprehensive nature as well as the extent of the shift it signaled from the legislation from which it took off. It was…See More
Jun 2
John Robinson posted a blog post

Upcoming FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods

The process of finalizing new food safety rules by the U.S. Food and Drug Administration (FDA) is underway. The accent of these upcoming FDA FSMA rules on the sanitary transportation of human and animal foods is the ways by which scientific and safe transportation and logistics involved in food transportation can be bettered. The FDA is required to establish rules for improving, auditing and enforcing new rules relating to food transportation. Congressional instructions have been issued for…See More
May 29

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

Quality Assurance Auditing for FDA-regulated industries

Quality Assurance Auditing for FDA-regulated industries5

An effective audit constitutes the heart of an effective Quality System. The FDA and other regulatory agencies have emphasized this principle time and again. The purpose of an audit program is to ensure proper and thorough compliance with the guidelines set out by the regulatory agencies. A…

Continue

Posted on July 26, 2017 at 5:51am

Which universities are pushing the boundaries in life sciences?

If you had to name the branch of university research that has the most tangible impact on mankind’s day-to-day activities, it is likely that the life sciences would be near the top of the list: not many days go by without the announcement of a new drug or gene discovery that has the potential to change lives or tackle disease.

Much of the best research in these fields takes place in the ultra-elite universities that excel in subjects across the…

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Posted on July 25, 2017 at 6:14am

Implementing ICH guidelines-compliant validation

Laboratory, Medical and Device2.jpg

Professionals in the field of statistical analysis need to possess clarity on understanding and interpreting statistical concepts used to investigate quantitative ICH Guidelines, such as:

  • Analytical methods validation
  • Procedures and acceptance criteria in calibration limits…
Continue

Posted on July 24, 2017 at 6:06am

An integrated approach is needed for Complaints Handling, Adverse Event Reporting, and Recalls

Adverse Event Reporting, and Recalls4

The fact that medical device manufacturers work and operate in various regulatory systems whose requirements are different and not always consistent with each other is recognized and empathized by the…

Continue

Posted on July 21, 2017 at 5:54am — 1 Comment

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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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Stevenson University posted a blog post

Social Media Do's And Don'ts

Stevenson University offers a wide range of graduate and professional study options.See More
7 hours ago
Profile IconPrarthana J V, Tejaswi Sharma, Stevenson University and 1 more joined Online Safety Community
8 hours ago
kate smith posted a blog post

An Explanation of the D.I.S.C. Personality Assessment

A 100-employee business spends an average downtime of 17 hours a week on just clarifying communications. In the process, it ends up losing over half a million dollars annually on this exercise. The reason: Lack of effective communication. This is at the heart of the problems that most organizations face. About 70% of small to mid-size businesses admit that communication is their primary problem.   The cost of…See More
8 hours ago
John Robinson posted blog posts
10 hours ago

Forum

Snowflake and Star Schema in Qlikview

In big name schema all of the facts are stored in one important table and the usage of number one key and overseas key courting different measurement tables are related with the fact desk.SNOWFLAKE…Continue

Tags: processing, transactional, qlikview

Started by Soujanya Naganuri yesterday.

What is Class Structure in Pega?

Class contains the rule by way of which objects behave. outline rules such as houses, sports, flows, html paperwork, etc. to be had to different subordinate classes. lessons are organized into a…Continue

Started by Soujanya Naganuri Jul 17.

How to Concatenate Two Tables in QlikView

Table combining and concatenationConcatenate appends the rows of one table to another. Concatenate never merges any rows. The number of rows in a concatenated table is always the sum of the rows of…Continue

Tags: datafields, developers, qlikview

Started by Soujanya Naganuri Jun 30.

SQL Server Windows Management Instrumentation Tasks

Hello,SSIS includes two special tasks that enable you to query system information and monitor system events: the WMI Data Reader Task and the WMI Event Watcher Task. These tasks are especially useful…Continue

Tags: Task, WMI, Server, SQL

Started by Madison Quinn Jun 20.

difference between NEBOSH and IOSH

NEBOSH “National Examination Board in Occupational Health and Safety”IOSH “Institution…Continue

Tags: kerala, IGC, NEBOSH

Started by mani May 31.

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