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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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swethakumar posted a blog post

Where to study the NEBOSH Course in Bangalore?

NEBOSH is a UK-based board conveying professional qualifications based on Occupational Health and Safety Management which has the syllabus to evaluate the workplace health and safety issue with proper preventive measures.NEBOSH Training in Bangalore by Green World Group is accredited by the international HSE awarding bodies like IOSH, IEMA, and IIRSM.This qualification has been designed for all kinds of people such as individuals, Managers, Supervisors, and Employees who require more extensive…See More
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Shaun Alex posted a blog post

The 5 Best Outlets for Promotional Products in New York, New York

The most densely populated and the most populous city of the nation, New York is rightly labeled as the global power city of the USA. Not only does it serve as a dominant node for the global economic network, but in fact, it has been described as the cultural, financial and media capital of the world as well. The city also serves as the residing home of the United Nations’ headquarters. The impact which it imbues can be felt across various channels and mediums of supremacy for arts, commerce,…See More
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Harassment, Bullying, Gossip, Confrontational and Disruptive Behavior: A Manager’s Guide on How to Detox and Neutralize a Negative Workplace at Training Doyens 26468 E Walker Dr, Aurora, Colorado 80016

November 19, 2019 from 1pm to 2:30pm
OVERVIEWBad attitudes, jealousy and disruptive behavior will sabotage hospital morale, lower self-esteem and reduce teamwork and productivity. When toxic behavior infects a department, managers may be tempted to ignore it or give in, the wrong thing to do, but tolerating it is not a solution!This session will show you how to neutralize gossip and put a system in place to…See More
9 hours ago

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EdbMails Office 365 Backup Software

Security approaches are principal to any organization’s protection and survival strategies. There are advanced types of attack that happen each day to take classified organization reports. To protect…Continue

Started by johnjorge 13 hours ago.

How to export EDB to PST successfully?

Microsoft Exchange Server maintains the data in EDB file format such as priv1.edb where it stores the private data of user mailbox, pub1.edb stores public data of user mailbox, .stm where these files…Continue

Started by marina paul on Friday.

Reasons for Office 365 email backup

The security enhancements and ease of access from anywhere are some of the major reasons why many organisations are willing to make the switch to the cloud from on-premises Exchange Servers.While…Continue

Started by johnjorge on Friday.

How EdbMails successful in deleted mailbox items recovery?

Are you wondering on how to get back your deleted mailbox items? Don’t be tensed to do the recovery of deleted mailbox items just go with EdbMails EDB to PST Converter tool that will show you how you…Continue

Started by clara dsouza on Thursday.

How EdbMails Exchange recovery reliable than manual methods?

When I immersed on manual method I couldn’t get actual result? Is there any other way to get successful result?Yes, Exchange server recovery third party tool works better, but how? Refer this…Continue

Started by marina paul on Wednesday.

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