This site is sponsored and maintained by Ansell, a global leader in protection solutions. Headquartered in Iselin, NJ, 11,000 employees across 42 countries design and manufacture innovative products relied on by millions of consumers, workers, first responders and healthcare professionals.
For more information about Ansell products and services, visit www.ansellpro.com, follow us on Twitter (@AnsellSafety) or become a fan on Facebook (Ansell Safety and Ansell Medical North America).
Posted by William Burns on February 16, 2017 at 11:10am
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…Continue
Posted by John Robinson on February 15, 2017 at 6:24am
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
Posted by Adam Fleaming on February 15, 2017 at 5:54am
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…Continue
Posted by Alex on February 14, 2017 at 4:32am
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
Posted by John Robinson on February 13, 2017 at 7:29am
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
Posted by Adam Fleaming on February 13, 2017 at 5:40am
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
Posted by Adam Fleaming on February 10, 2017 at 6:08am
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…Continue
Posted by John Robinson on February 10, 2017 at 4:20am
HR auditing: Key issues
Since HR auditing is directly related to the most important resource for an organization –its people –a Human resources audit is perhaps the most important of audits that an organization needs to carry out. HR auditing being the…Continue
Posted by kate smith on February 9, 2017 at 1:00am
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
Posted by Adam Fleaming on February 8, 2017 at 5:58am