To remain safe and free from harm you should consider the following 5 tips, which look at everything from tools and equipment, to hazards that cause trips and slips, and even poisonous plants.
Added by Alex on February 27, 2017 at 10:30am — No Comments
Whether you're an expert on load cells and capacitors or don't know your fusebox from your frappuccino, it pays to remind yourself of electrical safety procedures when you're working around electricity in any form. Even with years of electrical know-how, it's…Continue
Health and Safety Audit Software. Developed for and by Health and Safety Professionals. Reduce Time & Risk. Offline version for iPad & other mobile devices. Cost Effective Inspection Software. Contact Us Today.Continue
Added by William Burns on February 16, 2017 at 11:10am — No Comments
Course "How to build a complete Safety, Health & Environment Management System through Standards & Practices" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
A management system, by definition, is a process by which a function or…Continue
Added by John Robinson on February 15, 2017 at 6:24am — No Comments
Humans can be calibrated, although most people like to think otherwise. The commonly used standard, Attribute Agreement Analysis, or what is called AAA, is a handy tool in helping to do this. At its barest, Attribute Agreement Analysis is a method in which the level of agreement or conformance between the appraisal made by the appraiser(s) and the standard is assessed. Then, the elements used for the appraisal that have the highest levels of disagreement with the standard are…Continue
Added by Adam Fleming on February 15, 2017 at 5:54am — No Comments
As we all know, it’s crucial to make sure that appropriate levels of ventilation, filtration and comfortable ambient temperatures are maintained at all times in any workplace.
If you’re initially looking to put together a more generic list of workplace temperature, ventilation and filtration issues to keep a close eye on, here are five key basic checks for each…Continue
Added by Alex on February 14, 2017 at 4:32am — No Comments
The Design History File (DHF), the Technical File (TF) and the Design Dossier (DD) are core regulatory documents for a medical device. This is how one can understand the central difference between them: the Design History File (along with Design Control), is the most important among the regulatory documents that the FDA requires for medical devices, while the Technical File and Design Dossier are documents that serve the same purpose, however, within the EU’s regulatory…Continue
Added by John Robinson on February 13, 2017 at 7:29am — No Comments
Product Reliability is among the most important attributes for a product, no matter what kind of product one is considering. Product Reliability can be defined as the likeliness or probability of the product performing its stated purpose, in the light of the conditions under which it is going to be put, for a defined period of time.
The parameters used for quantification of Product Reliability are:
o MTBF or Mean Time Between Failures for products that can be repaired and…Continue
Added by Adam Fleming on February 13, 2017 at 5:40am — No Comments
After carrying out the initial preclinical studies, drug manufacturers need to implement cGMP quality systems and risk management approaches during commercial development and operations in order to be able to meet the requirements of the FDA’s current Good Manufacturing Practice (cGMP), which are contained in and are governed by regulations 21 CFR parts 210 and 211.
The FDA’s guidance on cGMP quality systems and risk management approaches is meant to help drug manufacturers implement…Continue
Added by Adam Fleming on February 10, 2017 at 6:08am — No Comments
Preparing premarket submissions that win regulatory approval is a complex task, even for the most seasoned professional in the medical devices industry. This is because of the highly stringent nature of the regulatory approval pathways, namely the Premarket Approval (PMA) process and FDA regulatory 510(k) clearance.
What makes preparing premarket…Continue
Added by John Robinson on February 10, 2017 at 4:20am — No Comments
Any company or individual that is required to submit IRS Form 1099 can avail a facility the Internal Revenue Service (IRS) has: the Taxpayer Identification Number (TIN) matching. This matching or likeness is among an assortment of e-services that gives what are called “authorized payers” the opportunity to match and state their own 1099 payee information with the pertinent records from the IRS. The TIN matching is a pre-filing facility, since it is done before an entity files information…Continue
Added by Adam Fleming on February 8, 2017 at 5:58am — No Comments
Added by John Robinson on February 7, 2017 at 6:20am — No Comments
Hazardous chemicals move through global markets, and so they must be labeled in a way that is universally understood in order to maximize safe handling and storage. A system that accomplishes this — the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) — recently was modified. U.S. employers had until June 1, 2016 to update their workplace labeling and hazard communication programs, in addition to providing training for newly identified hazards.
Added by Lynn Place on February 6, 2017 at 12:09pm — No Comments
Payroll laws set out the rules for which payroll regulations are to be enforced. Payroll laws and regulations have been enacted since it is through the payroll that employees not only get paid; it is also the same source for taxation and other deductions. Every organization that has a payroll system has to adhere to these payroll laws and regulations. The…Continue
Added by John Robinson on February 6, 2017 at 6:21am — No Comments
The in-vitro diagnostics (IVD) market is a diverse and fast changing one. Of late, one of the significant changes that happened to it resulted from the passage of the Final Rule. As part of the Affordable Care Act (ACA) or Obamacare, the Centers for Medicare and Medicaid Services (CMS) introduced the Final Rule to the 2014 Protecting Access to Medicare Act (PAMA) in mid-2016, which is set to make a significant impact on the in-vitro diagnostics market by delaying implementation of…Continue
Added by Adam Fleming on February 6, 2017 at 6:19am — No Comments
Quality is everything for a product or service. Quality is defined in different ways. One of the well-known definitions of Quality is the ability of a product or service to reach expected levels of excellence. This is a simple theoretical definition. In practice, though, Quality is a highly painstaking area of activity that is necessary across all functions of all industries. If a product does not meet its quality requirements or criteria, it is doomed to failure.…Continue
Added by John Robinson on February 3, 2017 at 8:01am — No Comments
Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide materials and services to the device manufacturer, which means that they can be critical to performance and delivery of your device. Neither the FDA nor your notified body regulates your suppliers (with a few…Continue
Added by John Robinson on February 1, 2017 at 4:30am — No Comments