Online Safety Community

All Blog Posts (1,400)

Good Manufacturing Practices are essential for ensuring quality

Key Takeaway:

GMPs are critical for the manufacture and distribution of foods, drugs and other pharmaceutical products. These need to be implemented diligently by organizations that are involved in these products.

Quality is a great concern for a manufacturer and consumer of any product. To ensure that quality is maintained across a variety of products ranging from foods to pharmaceutical products; a few guidelines are required. These guidelines…

Continue

Added by John Robinson on April 26, 2017 at 8:06am — No Comments

Article on “Statistical Sampling Plans for Medical Devices”

Continue

Added by John Robinson on April 21, 2017 at 6:04am — No Comments

Understanding the ways of conducting shrink investigations

Shrink investigation is essentially about examining the causes of shrink (loss) in retail businesses. Although retail is one of the fastest growing areas of business, the possibility of shrink is very high in this area. It is also an overlooked area, because of which many shrinks that could otherwise have been prevented, do not get prevented.

Controlling losses is as important…

Continue

Added by Adam Fleaming on April 21, 2017 at 6:02am — No Comments

Leadership Management Academy 201-202: Rising Through the Management Ranks 2017

Overview:

Why Should You Attend?

By attending, you will take advantage of a great opportunity to advance as a manager to the next level!

Too often, we focus on getting things done and…

Continue

Added by John Robinson on April 20, 2017 at 7:20am — No Comments

Writing error-free procedures while complying with GMP regulations

In the area of GMP regulations, procedures are very vital, for both execution and audits. It is always true that the greater the clarity and comprehensiveness with which these procedures are written; the easier it becomes for users to use them without missing important information for regulators.

Despite the advent of technology into almost all the areas of GMP regulations; there is still the existence of the human factor. It is still the major…

Continue

Added by Adam Fleaming on April 19, 2017 at 6:43am — No Comments

Rising in one’s career through leadership management

Continue

Added by John Robinson on April 19, 2017 at 5:09am — No Comments

Packaging and labeling are important components of commercial and clinical products

Packaging and labeling of commercial and clinical products are very important aspects to an organization involved in a business that relates to these products. While the packaging and labeling of commercial products is important, it is more so with clinical products, because these products play an important role in a clinical trial and also in the very life of a patient or subject.

Commercial products have their own value over time. The FDA has guidances for…

Continue

Added by Adam Fleaming on April 17, 2017 at 8:41am — No Comments

FDA and EU requirements on data integrity and implementation

Continue

Added by John Robinson on April 17, 2017 at 5:49am — No Comments

Are Your Test Methods Ready for Quality Control or any laboratory ?

The FDA considers verification and transfer of Test Methods a subject worthy of 483 observations and issuance of Warning Letters. Test method verification is also required by the GMPs, and USP has a whole chapter dedicated to test method verification. This makes comprehension of the requirements for the verification and transfer of a test method into a laboratory imperative for Laboratory Managers and other personnel.…

Continue

Added by Adam Fleaming on April 12, 2017 at 6:42am — No Comments

Applied Statistics for FDA Process Validation 2017

Continue

Added by John Robinson on April 12, 2017 at 5:29am — No Comments

How the supposed microbial control or monitoring approach SHOULD be handled.

That water systems are critical to the pharmaceutical industry is a given. This fact makes it absolutely imperative for pharmaceutical companies to get a grasp of the techniques needed for getting these systems right. Product recall, costly downtime and many other related negatives are some of the consequences of not getting these matters right.

Among the primary causes,…

Continue

Added by Adam Fleaming on April 10, 2017 at 6:24am — No Comments

Procurement and Contract Fraud is usually off -the books- and difficult to detect and investigate

In this interconnected, interdependent global world, the need for contracting procurement of any goods or services is strong and indispensable. However, the benefits of this feature notwithstanding, there are several loopholes in the procurement and contracting activity. Outsourcing and contracting, by their very nature, are vulnerable to fraud. Fraud can happen at any stage of the procurement and contract process.…

Continue

Added by Adam Fleaming on April 6, 2017 at 5:59am — No Comments

What to expect during GMP Inspection

Regulatory agencies such as the FDA conduct inspections for product-related Good Manufacturing Practice (GMP) in the course of assessing an application for marketing approval. The basic purpose of product-related GMP inspections is to check for compliance with the GMP guidelines set out in the International Conference on Harmonization (ICH) and national and local GMP regulations. GMP is the slightest standard that a manufacturer has to mandatorily meet in its production…

Continue

Added by Adam Fleaming on April 3, 2017 at 6:29am — No Comments

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 Fleaming 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 Fleaming 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 Fleaming 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 Fleaming 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 Fleaming on March 22, 2017 at 6:04am — No Comments

Monthly Archives

2017

2016

2015

2014

2013

2012

2011

2010

2009

2008

2005

1999

Take our poll!

Take our poll!

Latest Activity

Profile IconScott Dollar and Nicole J Gomez joined Online Safety Community
5 hours ago
John Robinson posted a blog post

Good Manufacturing Practices are essential for ensuring quality

Key Takeaway:GMPs are critical for the manufacture and distribution of foods, drugs and other pharmaceutical products. These need to be implemented diligently by organizations that are involved in these products.Quality is a great concern for a manufacturer and consumer of any product. To ensure that quality is maintained across a variety of products ranging from foods to pharmaceutical products; a few guidelines are required. These guidelines are collectively termed Good Manufacturing…See More
13 hours ago
John Robinson posted a blog post

Tips and Suggestions on interacting with FDA Officials and Premarket Approval (PMA)

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 FDA regulatory 510(k)…See More
yesterday
Zuber Ahmed posted a discussion

Feedback on a injury prevention product we're building.

Hi everyone!For full transparency ill tell you a little about myself and what I hope to accomplish. My name is Zuber and I'm an engineering student who founded a startup helping to build wearable tech to help prevent injury in the workplace. What initially was a pet project for the gym has turned into a startup where I'm working along side Kinesiology and engineering professors at my school to help bring his product to fruition. I should add that I have no intention of selling or pushing our…See More
Monday

Forum

What's your favorite motivational/safety quote? 98 Replies

Favorite Motivational Quote: If you want something, you'll find a way - If not, you'll find an excuse.Favorite Safety Quote: Don't learn safety by accident!Continue

Started by Michelle Sears. Last reply by David R Snell 3 hours ago.

Feedback on a injury prevention product we're building.

Hi everyone!For full transparency ill tell you a little about myself and what I hope to accomplish. My name is Zuber and I'm an engineering student who founded a startup helping to build wearable…Continue

Tags: product, prevention, injury, back, safety

Started by Zuber Ahmed on Monday.

Best overall personal safety book? 1 Reply

What do you think is  the best all-in-one book out there for optimizing personal safety and the safety of one's family?  Right now I have …Continue

Started by David R Snell. Last reply by David R Snell on Friday.

Fire codes for residential buildings

Hi,Can anybody kindly give me a hint how to find Fire Codes for residential buildings in different cities in the United States?Continue

Started by Darren Asad Apr 14.

OSHA and Machine Guard Door Safety???

We have what we feel is not a unique situation and were wondering if anyone might of run across this challenge and know more about the requirements.  We are building a small machine system that…Continue

Tags: electric, osha, air, door, interlocked

Started by Scott V Mar 24.

Badge

Loading…

© 2017   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service