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April 2017 Blog Posts (17)

4 eco-friendly safety essentials to help save the world

The health and safety sector and the green sector now thankfully meet with a selection of products that are effective in preventing harm to workers, while also benefitting the environment. Such developments are important factors in the modern workplace, which wants to keep employees safe and now also…

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Added by Alex on April 28, 2017 at 7:00am — No Comments

The art of writing effective audit observations

Audits are a means of evaluating operations and other functions of an organization. ISO 19011:2011 Guidelines for Auditing Management Systems describes audits as a process used for gathering the evidence of verifiable documents and map their suitability, alignment and fulfilment with the company’s policies and procedures.

An audit is an important tool that helps organizations to analyze opportunities, implement best practices, and assess all the important factors in…

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Added by Adam Fleaming on April 27, 2017 at 6:29am — No Comments

Article on “A Tour of the FDA”

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Added by John Robinson on April 27, 2017 at 5:50am — No Comments

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…

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

Article on “Statistical Sampling Plans for Medical Devices”

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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…

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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…

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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…

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

Rising in one’s career through leadership management

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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…

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

FDA and EU requirements on data integrity and implementation

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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.…

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

Applied Statistics for FDA Process Validation 2017

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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,…

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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.…

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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…

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

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Latest Activity

Tom Clark posted a blog post

5 Reasons Why Teens Get Addicted to Alcohol and Drugs

Teenage can be considered as the most difficult period of life. During the teenage years, boys and girls become so desperate that they can do anything they wish. It is basically a vulnerable time when teens try to navigate the bridge between adulthood and childhood. Teens are the most rebellious and as per the study, this is the reason why they get involved in anti-social activities. Not only that, they often become addicted to drug and alcohol because of their rebellious nature.Now this is not…See More
16 hours ago
Jam Blanco posted a blog post

Response to Marine Oil Spills

Oil spills can wreak havoc on the environment and cause irreversible damage if they aren’t controlled in a timely manner. However, emergency responders need to be trained to react to emergencies quickly and efficiently to prevent more damage. The type of training they receive should depend on their proximity to the spill and whether they need to stop, contain or recover oil from release.For instance, workers who are assigned as early responders to an oil spill should be given more training…See More
17 hours ago
Adam Fleaming posted a blog post

Where does GMP Training end and HR training begin?

That pharmaceutical companies need to hire professionals with the requisite qualifications is beyond question. This is not only required for the smooth conduct of activities in their course of their day-to-day work, but also because the FDA has set out its requirements for the proper educational and skill set qualification of employees in this profession in 21 CFR 211.25(a).This FDA section underlines the need for educational qualifications, training and experience to carry out their job…See More
19 hours ago
Training Doyens posted events
yesterday

Forum

Python Condition Objects Tutorial in 2018

If you have knowledge of other programming languages, then you would know the importance of conditional statements. Conditional statements are required for taking decisions. Whenever we operate the…Continue

Tags: course, certification, training, languages, programming

Started by Elena Lauren Apr 2.

Automation Anywhere. How do I pick a value from dropdown 1 Reply

Automation Anywhere. How do I pick a value from dropdown. I tried 'set text' from a copied variable. Its very slow, and also doesnt…Continue

Tags: anywhere, automation

Started by emmablisa. Last reply by venkatesh Mar 29.

Agile overcome common software security challenges

Paradoxically, security is a negative goal. To secure something, you must understand how insecure it is. Start by trying to break it or by figuring out how other people might break it. The same is…Continue

Tags: agile, scrum, security

Started by nicolewells Mar 23.

Understanding Data Parallelism in MapReduce

In order to understand the goals of MapReduce, it is important to realize for which scenarios MapReduce is optimized. The MapReduce programming model is created for processing data which requires…Continue

Tags: program, Implementation, Mapreduce

Started by gracylayla Mar 14.

TensorFlow serving vs TensorFlow service

I have a question regarding the difference between TensorFlow Serving versus TensorFlow service. (Sorry that I'm not familiar with this at all.)I found TensorFlow serving's definition, which is "…Continue

Tags: training, online, tensorflow

Started by emmablisa Feb 27.

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