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June 2016 Blog Posts (6)

A broad look at clinical research regulations

Clinical research regulations are directives that are aimed at making clinical research more effective and ethically justifiable. The tool or mechanism by which regulators ensure that clinical research regulations serve their purpose is what is called Good Clinical Practice (GCP).

Regulatory bodies around the world, irrespective of whether they function at national or global levels, formulate respective clinical research regulations that are aimed at ensuring that…

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Added by Adam Fleming on June 10, 2016 at 3:16am — No Comments

What are the functions of computer system validation process?

Computer system validation process is described as the documented procedure which assures that a computer system performs the exact functions it is intended to reproducibly, consistently and verifiably. The computer system validation process covers every function and milestone of the computer system:

  • Development of the system
  • Operation of the system
  • The system’s maintenance
  • Its retirement
  • Archiving…
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Added by Adam Fleming on June 7, 2016 at 2:24am — No Comments

Effective Steps for Validation and 21 CFR Part 11 Compliance (CSV)

If one were to define validation; it can be considered the deed of testing an item or system for the level or extent to which it complies with a standard that it has to show compliance with.

In the case of computer systems, validation is a major requirement for these regulatory bodies/practices:

  • The US FDA
  • European Medicines Agency (EMA)
  • Good Manufacturing Practices (GMP)
  • Good Laboratory Practices (GLP)
  • Good Clinical Practices…
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Added by John Robinson on June 6, 2016 at 2:30am — No Comments

The emerging discipline of Hospitals Management Performance Assessments

The emerging discipline of Hospitals Management Performance Assessments

Over the past few years, Hospitals Management Performance Assessments have begun to gain acceptability and credence in healthcare circles. Hospitals Management Performance Assessments came into being as a result of a conscious effort by advanced countries, mainly European, with sufficient backing from the World Health Organization (WHO) to arrive at some sort of metrics…

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Added by Roger Steven on June 2, 2016 at 7:10am — No Comments

Implementation requirements of FDA's Bioresearch Monitoring Program

If there is one common cause for apprehension between the smallest and biggest, and the best known and least known organizations; it has to be an FDA inspection! Any organization that is subject to an FDA inspection has to get absolutely everything of everything about its activities right to a T, to such an extent that it should be sure simply all the time, through all its processes, that an FDA inspection is not going to invite an FDA action such as a 483…

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Added by Adam Fleming on June 2, 2016 at 3:08am — No Comments

It is important to ensure food safety in hospitals

It is important to ensure food safety in hospitals

Food-Services

Hospitals being what they are – where patients of almost all kinds visit or stay – are very potent sources of infection. Infection can arise from any part of the hospital. They can spread from patients to patients, from caregivers to patients, from patients to caregivers, from patients to support or administrative staff and vice versa, and so on. An often overlooked source of infection and contamination…

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Added by Roger Steven on June 1, 2016 at 7:16am — No Comments

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Adam Fleming posted an event
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21 CFR Part 11 - Compliance for Electronic Records and Signatures at Online

June 26, 2019 from 10am to 11am
Overview: This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records as described in the FDA Guidance will be explained.FDA regulated companies want to transition to electronic records for economy and efficiency. FDA, because of its concern for patient safety, wants to prevent electronic records from being…See More
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Mark Nilson posted an event

Data analysis with Pivot Tables: take your knowledge to the next level at Training Doyens 26468 E Walker Dr, Aurora, Colorado 80016

July 2, 2019 from 1pm to 2:30pm
OVERVIEWLearning how to create Pivot Tables in Excel is one of the must-have skills for anyone who needs to use Excel to build business reports and summaries. Our upcoming webinar discusses how to quickly and easily build reports and charts that help in spotting trends and making crucial business decisions.The webinar covers the following key areas:Calculating month-on-month difference and using conditional formattingUsing…See More
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Kelly Wilson posted a blog post

Value of Locating the Right Plastic Surgeon

If you are taking into consideration for any plastic surgery treatment, discovering the best plastic surgeon is of prime importance. There might be several plastic surgeons supplying plastic surgery, as well as you have to find a plastic surgeon that can aid accomplish your visual objectives. As laser lipo is an advanced procedure, just a doctor having the right skills can guarantee you risk-free and optimal outcomes. Pointed out here are some of the factors for choosing the…See More
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Creating Raving Fans for Business: How to Develop a Winning Strategy for Client Retention and Customer Satisfaction at 26468 E Walker Dr, Aurora, Colorado 80016

July 31, 2019 from 1pm to 2:30pm
OVERVIEWA ‘Strategy of Pre-eminence’ and understanding what ‘Moments of Truth” are, gets this session underway. When you learn the actual $ dollar value of one of your customers, gained or lost, you may start looking at training in customer service in a better light.We will look at three key customer complaint and resolution questions everyone needs to know:What causes…See More
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Workplace safety for workers other than your own 3 Replies

Do your workplace/traffic safety plans include safety measures for workers who are not your own employees? Do they take into account the safety of those who will be - or could be - at your workplace,…Continue

Tags: emt, paramedics, emergency, occupational, health

Started by John Petropoulos Memorial Fund. Last reply by Paul Lancaster May 28.

Imagine a technology which is an artificial muscle and is integrated into textiles...

Such a smart textile has huge application potential and can support people in many different ways. The garment would use haptic feedback (i.e. the use of touch to guide the user) or could serve as a…Continue

Started by Ulla Siegel May 28.

Green Smart Technical 800+ Turnkey Projects in UAE – Rope Access Company in Dubai

Green smart is an ISO 9001: 2015 QMS, OHSAS 18001: 2017 OHSMS, ISO 14001: …Continue

Tags: window, cleaning, services, facade, companies

Started by Manikandan Apr 23.

What % of Dollars should be bugeted for All Safety Training for a "Heavy Equipment Road Construction" company with 100 employees? 1 Reply

I have been at a Highway and Road Construction company for six months. I am developing a (first) complete training program. I am the 1st full time safety hire for this company. I need to develop a…Continue

Started by JTurpening. Last reply by Jen McDade Feb 19.

Technology and Safety 1 Reply

What are the most useful tools to have at your fingertips? -Toolbox Talks-JSA-JHA-Daily Reports, etc. What is falling through the cracks that could be an easy fix? Safety Managers, Coordinators and…Continue

Tags: safety

Started by Drew stone. Last reply by Jen McDade Feb 15.

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