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John Robinson's Blog (255)

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…

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Added by John Robinson on January 9, 2019 at 6:44am — No Comments

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…

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Added by John Robinson on January 7, 2019 at 7:28am — No Comments

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…

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Added by John Robinson on January 2, 2019 at 5:58am — No Comments

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…

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Added by John Robinson on December 14, 2018 at 5:48am — No Comments

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.…

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Added by John Robinson on December 10, 2018 at 7:02am — No Comments

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…

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Added by John Robinson on November 29, 2018 at 6:19am — No Comments

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…

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Added by John Robinson on November 26, 2018 at 7:38am — No Comments

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…

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Added by John Robinson on November 22, 2018 at 6:37am — No Comments

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…

Continue

Added by John Robinson on November 20, 2018 at 7:38am — No Comments

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…

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Added by John Robinson on November 19, 2018 at 7:33am — No Comments

Concerned about health and safety on the job?



OSHA 1 https://globalcompliancepaneltraining.files.wordpress.com/2018/02/osha-1.jpg?w=150 150w,…

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Added by John Robinson on February 20, 2018 at 4:55am — No Comments

Risk Management in the Global Economy and outlook for 2017



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Risk management in the global economy is a highly challenging field for risk managers from any part of the world. With most of the world’s countries almost…

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Added by John Robinson on February 19, 2018 at 4:34am — No Comments

An understanding of Risk Management and Analysis for Medical Device Manufacturers



Risk Management and Analysis1.jpg https://globalcompliancepaneltraining.files.wordpress.com/2018/02/risk-management-and-analysis1.jpg?w=914&h=620 914w,…

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Added by John Robinson on February 16, 2018 at 5:28am — No Comments

Benefits of Risk Management in all Industries 2018



Benefits of risk management in all industries3 https://globalcompliancepaneltraining.files.wordpress.com/2018/02/benefits-of-risk-management-in-all-industries3.jpg?w=892&h=434 892w,…

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Added by John Robinson on February 15, 2018 at 4:35am — No Comments

Ways of managing risk in construction projects



Ways of managing risk in construction projects 1

The ways of managing risk in construction projects need to be drilled down into the systems that are used in construction projects. Managing risk in…

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Added by John Robinson on February 14, 2018 at 4:59am — No Comments

How is Risk Management Important to Project Success?



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The answer to how risk management is important to project success is best illustrated by the fact that no project has ever succeeded without proper risk…

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Added by John Robinson on February 13, 2018 at 5:06am — No Comments

Risk management methods and tools in the pharmaceutical and life sciences industries

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Understanding and implementing risk management methods and tools is crucial for the pharmaceutical and life sciences industries in view of the fact that errors in this area can lead to dangers for human life. Since any mistake in any chain of in this industry can lead to serious consequences; the FDA and other regulatory…

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Added by John Robinson on February 12, 2018 at 5:09am — No Comments

It is important for organizations to validate their own Excel Spreadsheet Application



It is important for organizations to validate their own Excel Spreadsheet Application.jpg https://globalcompliancepaneltraining.files.wordpress.com/2018/02/it-is-important-for-organizations-to-validate-their-own-excel-spreadsheet-application.jpg?w=150 150w,…

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Added by John Robinson on February 9, 2018 at 4:50am — No Comments

What is Emergency Planning and Community Right-to-Know Act (EPCRA)?



The Emergency Planning and Community Right-to-Know Act is a significant milestone in the detection and prevention of hazardous chemicals. The US Congress enacted this law in the wake of the Bhopal disaster in India. It seeks to involve…

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Added by John Robinson on February 8, 2018 at 5:03am — No Comments

OSHA’s standard on Respiratory Protection Safety Management Systems



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Respiratory protection safety management system is a need for people who work in areas that require respiratory systems. Such people are exposed to various types of contamination, because of which they will be required to put on protective systems. The aim…

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Added by John Robinson on February 7, 2018 at 4:54am — No Comments

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Live Webinar on Excel as a BI Tool: Pivot Tables Part 1 at 26468 E Walker Dr, Aurora, Colorado 80016

February 4, 2019 from 1pm to 2pm
OVERVIEWMicrosoft Excel Pivot Tables are one of the most powerful tools in Excel’s data analysis and Business Intelligence (BI) armoury.  With just a few clicks of the mouse (and no complicated formulas!) you can quickly and easily build the reports, dashboards and charts that help you to summarize, analyze, interpret and understand your data which in turn helps you to…See More
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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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