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March 2017 Blog Posts (13)

Effective cleaning validation procedures for analytical equipment

Regulatory agencies the world over have put in place stringent requirements for ensuring that cleaning validation procedures for analytical equipment are effective. Even if putting these practices in place involves expense and effort, it is worth the trouble, because the cost of noncompliance is much, much higher than that of compliance.

Noncompliance with regulations for cleaning validation procedures for analytical equipment has a serious consequence: Regulatory…

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Added by Adam Fleming on March 30, 2017 at 6:42am — No Comments

What is the real role of a safety advisor?

The Role of Safety Advisor in Organisations – Essential Reading

measuring safety Whilst everyone wants to do ‘safety differently’, it is not likely that reform will come within. The paradigm of safety with its primary focus on measurement actually mitigates any hope of innovation, creativity or critical thinking. If…

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Added by David Collins on March 29, 2017 at 11:16pm — No Comments

Establishing Latest Quality Systems in medical device and pharmaceutical industries

Establishing Quality Systems is one of the central aspects of a medical device and/or pharmaceutical organization. Establishment of Quality Systems is also a regulatory requirement, as set out by the FDA and the ISO.

The process of establishment of Quality Systems for FDA-regulated medical devices industries is set out in 21 CFR Part 820. Further, the ISO has its standard for how to establish Quality Systems in medical devices industries –the ISO 13485 standard…

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Added by Adam Fleming on March 28, 2017 at 9:06am — No Comments

Right now Medical device hazard analysis, the core of medical devices

Medical device hazard analysis is of vital importance to a medical device. Medical device hazard analysis is at the heart of medical devices because if the device is not analyzed thoroughly for the hazard, or danger, that it poses, it is likely to cause problems of any kind to the user. Many a time, it becomes a matter of life and death. This is why medical device hazard analysis is of foremost importance.…

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Added by Adam Fleming on March 27, 2017 at 8:31am — No Comments

Works Quickly Meeting the FDA’s Quality and compliance requirements

Quality and compliance are vital issues for any medical devices company. Despite the fact that the FDA’s regulatory compliance requirements are the same across the industry; many medical device companies are shocked when they receive a 483, or a Warning Letter, or even a consent decree. Is meeting the FDA’s regulatory requirements something of a chance, which some organizations get by fluke and others don’t?…

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Added by Adam Fleming on March 24, 2017 at 6:31am — No Comments

Today’s Pre control and Statistical Process Control (SPC)

Pre control and Statistical Process Control (SPC) are key tools for determining the process that goes into a product.

SPC is a key ingredient of Quality. It is an important step in reducing nonconformities and defects in any manufacturing process. SPC charts help to detect assignable causes of a process change in a timely fashion. SPC helps to identify root causes and take corrective actions before the development of the product has reached such a stage that…

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Added by Adam Fleming on March 22, 2017 at 6:04am — No Comments

A look into the 21st Century Cures Act

Considered one of the most significant changes to be introduced into the American healthcare sector since the passage of the Affordable Care Act; the 21st Century Cures Act was one of the last legislative acts of outgoing president Barack Obama. Signed into law in December 2016; the 21st Century Cures Act seeks to strengthen medical research, foster innovation and accelerate the development of innovative treatments for chronic ailments such as cancer.…

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Added by Adam Fleming on March 16, 2017 at 6:00am — No Comments

Lyophilization: Validation and regulatory approaches

Lyophilization and its validation and regulatory approaches form an important aspect of parenteral drugs.



Lyophilization is a process in which a product is frozen and placed in a vacuum and water is removed from it. This removes the need for the liquid stage in the change of ice from solid to vapor. This process consists of three phases: primary, sublimation and desorption.



Lyophilization is considered complex



Parenteral products such as anti-infective drugs,…

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Added by Adam Fleming on March 15, 2017 at 6:18am — No Comments

Understanding and handling payment issues

A financial organization, or an organization involved in any business for that matter, faces the prospect of receiving duplicate, fraudulent or late payments. These are the typical payment issues an organization is likely to face at some point of time in its business.

Payment issues are something almost no organization is likely to be free from. Duplicate invoice payments, just one of the payment issues an organization is likely to face, account for losses of…

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Added by Adam Fleming on March 13, 2017 at 6:02am — No Comments

Five steps for safer use of solvent-based paints

When it comes to deciding between using solvent-based or water-based paints for a given job, we all know the basic pros and cons: water-based paints will typically smell less offensive, be easier to clean up, and present less risk to health…

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Added by Alex on March 13, 2017 at 5:30am — No Comments

Understanding normality tests and normality transformations

That the inputted data should be “normally distributed” is a requirement of the calculations used in many statistical tests and methods. Typically, the methods used for Student’s t-Tests, ANOVA tables, F-tests, Normal Tolerance limits, and Process Capability Indices include such calculations.

A core criterion for ensuring the correct results is the one that the raw data used in such calculations be “normally distributed”. It is in view of this fact that the…

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Added by Adam Fleming on March 10, 2017 at 5:39am — No Comments

The importance of Design of Experiments (DoE)

Design of Experiments (DoE) is an important component in many industries. It is a series of tests or runs that is carried out repeatedly and consistently over a period of time, and its outputs or responses, observed. Design of Experiments is very important in industry to help arrive at an understanding of the predictability and reproducibility of an experiment.

Design of…

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Added by Adam Fleming on March 8, 2017 at 5:12am — No Comments

Analyzing financial statements is an indispensable insight for managers

Financial statements are the ultimate indicator of a company’s financial health. Number crunching is a very important exercise that all executives at all levels of an organization need to be familiar with. Yet, given the heavy jargon that goes into financial statements and the complexity most of them have; many managers feel put off and don’t generally like to pore over financial statements.

The company’s financial statement is intended to provide insights into the…

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Added by Adam Fleming on March 3, 2017 at 5:34am — No Comments

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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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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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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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