Online Safety Community

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…

Continue

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…

Continue

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…

Continue

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.…

Continue

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?…

Continue

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…

Continue

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.…

Continue

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,…

Continue

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…

Continue

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…

Continue

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…

Continue

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…

Continue

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…

Continue

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

Monthly Archives

2018

2017

2016

2015

2014

2013

2012

2011

2010

2009

2008

2005

1999

Take our poll!

Take our poll!

Latest Activity

Mark Nilson posted events
7 hours ago
Training Doyens posted events
9 hours ago
HrishikeshRam posted a blog post

Fire Protection safety Tips for Schools

While the number of school fires has decreased over recent years, they continue to be a serious risk for schools. Every year around one in twenty schools experiences a fire and nearly hour of faculty fires are started deliberately.The short effects of loss of facilities and instrumentation may be calculated, however the longer-term effects of loss of work, disruption of…See More
10 hours ago
Pro-Sapien Software posted a blog post

Pro-Sapien partners with LMS365 to offer integrated Learning Management on Office 365

Pro-Sapien Software, specialist providers of EHS software on Office 365, has announced its partnership with fellow Microsoft ISV ELEARNINGFORCE International to offer Training Management alongside Pro-Sapien’s HSEQ Innovate.ELEARNINGFORCE’s product LMS365 empowers people through learning management fit for the Modern Digital Workplace. Managers can create, distribute, and track learning courses; employees can manage their own learning schedule with progress trackers, notifications and…See More
yesterday

Forum

AI Machine Learning In Businesses How wоuld уоu define a small buѕinеѕѕ, thе number оf реrѕоnеl, thе size оf the budget, оr ѕаlеѕ?

How wоuld уоu define a small buѕinеѕѕ, thе number оf реrѕоnеl, thе size оf the budget, оr ѕаlеѕ?However you define уоur оwn ѕmаll business, it tоо can tаkе advantage оf thе AI/ …Continue

Tags: elite, crest, technologies, intelligence, Artificial

Started by emmablisa on Monday.

Distracted Driving 1 Reply

****WARNING**** Despite the fact that this is a life event portrayed by actors, it's graphic. This video should be part of…Continue

Tags: texting, fatality, safety, car, driving

Started by Wendy. Last reply by Jen McDade Dec 5.

Safety update: OSHA announces fit-test procedures 1 Reply

Fabricators as well as other workers may be required to use respirators to protect themselves from inhaling fumes, particles, or dust when performing cutting, grinding, welding, coating, or painting,…Continue

Tags: online, training, Safety, workplace, PPE

Started by Safety Training International. Last reply by Jen McDade Dec 4.

Proper guarding protects workers: Six steps to focusing on your employees' needs 1 Reply

When people think of machine guarding, usually they think of devices to protect people from the moving parts on machinery.When people think of machine guarding, usually they think of devices to…Continue

Tags: training, compliance, PPE, Training, Safety

Started by Safety Training International. Last reply by Jen McDade Dec 4.

Badge

Loading…

© 2018   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service