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John Robinson
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  • Fremont, CA
  • United States
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John Robinson posted a blog post

How to interpret and use more than just a standard tool-box

How to apply statistics to manage risks and verify/validate processes in R&D, QA/QC, and Manufacturing, with examples derived mainly from the medical device design/manufacturing industry. The flow of topics over the 2 days is as follows:ISO standards and FDA/MDD regulations regarding the use of statistics.Basic vocabulary and concepts, including distributions such as binomial, hypergeometric, and Normal, and transformations into Normality.Statistical Process ControlStatistical methods for…See More
Jan 23
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
Jan 18
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 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

How to be Efficient and Compliant with Part 11

This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments.Many companies are outsourcing IT resources and getting involved with Software as a Service (SaaS) and cloud computing. These vendors are not regulated and therefore regulated companies must ensure compliance for both infrastructure qualification and computer system validation. It is the regulated company that wants to…See More
Nov 19, 2018

Profile Information

Tell us about yourself:
GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient.

GlobalCompliancePanel imparts knowledge of best practices across a broad range of user-friendly mediums such as webinars, seminars, conferences and tailored, individualized consulting. These help organizations and professionals implement compliance programs that meet regulatory demands and put business processes in place.

GlobalCompliancePanel focuses primarily on providing extensive and quality training in these core areas and anything related to them:
Risk Management
Regulatory Compliances
Corporate Governance
Quality Management
Are you lucky enough to be living in a log home?
CA
What timeframe are you looking to start your dream home?
N/A
Website:
http://https://www.globalcompliancepanel.com/

John Robinson's Blog

How to interpret and use more than just a standard tool-box

How to apply statistics to manage risks and verify/validate processes in R&D, QA/QC, and Manufacturing, with examples derived mainly from the medical device design/manufacturing industry. The flow of topics over the 2 days is as follows:

  • ISO standards and FDA/MDD regulations regarding the use of statistics.
  • Basic vocabulary and concepts, including distributions such as binomial, hypergeometric, and Normal, and transformations into Normality.
  • Statistical…
Continue

Posted on January 23, 2019 at 6:51am

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 6:16am

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 7:44am

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 8:29am

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At 1:45pm on March 19, 2018, Joyce said…

Good Day,

How is everything with you, I picked interest on you after going through your short profile and deemed it necessary to write you immediately. I have something very vital to disclose to you, but I found it difficult to express myself here, since it's a public site.Could you please get back to me on:(mrs.joycegyimah@gmail.com) for the full details.

Have a nice day

Thanks God bless.

Joyce.

 
 
 

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