Wednesday, October 30, 2013

2014 GMP Training Ideas - Root Cause Analysis of Deviations Workshop

2014 GMP Training
Root Cause Analysis of Deviations:

This course is more than idle chat. In this workshop, students apply root cause analysis tools to real in-plant deviations.

Tools addressed in this very popular workshop:
1. 5-Whys In-Depth Map
2. Sequence of Events
3. Distinctions
4. Walk-Through Analysis
5. Change Analysis
6. Control Barrier Analysis
7. Fishbone Diagrams and more!

If your firm is not satisfied with the quality of deviation investigations, then you need to look into our Root Cause Analysis of Deviations workshop!

Follow this link to learn more about our Root Cause Analysis of Deviation Workshop (a GMP training course)

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Tuesday, October 29, 2013

Thinking of quitting smoking? Mondays may be your day : USA Today

Thinking of quitting smoking? Mondays may be your day - USA Today:

"There's no such thing as a bad day to stop smoking, but a new study shows Monday is a particularly popular day to think about it – or at least Google it.

Google searches for terms such as "quit smoking help" make up a higher proportion of all searches on Mondays than on any other day . . . "

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Monday, October 28, 2013

2014 GMP Training Recommended: The Qualstar Simulation


Qualstar - A CGMP Simulation:

Designed to teach and to change the culture of companies, so that a focus on quality and compliance is achieved. This competitive simulation is an eye-opener for participant and executive staff observers alike.

Issues addressed in this exciting simulation:
1. Documentation problems
2. Procedures not being followed
3. Change control not practiced
4. QA not consulted on deviations

If this describes some of your issues, then you need to experience Qualstar!

Follow this link to learn more about Qualstar - A cGMP Simulation (a GMP training course)

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Sunday, October 27, 2013

FDA > Decorative Contact Lenses: Is Your Vision Worth It?

Consumer Updates > Decorative Contact Lenses: Is Your Vision Worth It?:

"But before buying decorative lenses, here’s what you should know:

They are not cosmetics or over-the-counter merchandise. They are medical devices regulated by the Food and Drug Administration (FDA). Places that advertise them as cosmetics or sell them without a prescription are breaking the law."

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cGMP basics training for newbies and seasoned staff

#FDA #GMP #cGMP #training #course #class

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If you are looking for live, onsite, in-person delivered courses or classes, then consider the following popular courses:
Root Cause Analysis & Deviation Investigation Report Writing - cGMP Training
Our most popular course
Qualstar - Pharmaceutical Simulation - Advanced cGMP Training
Put fun back into GMP training!















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As nanotechnology is being used to develop new drugs, FDA is working to ensure quality, safety, and effectiveness | FDA Voice

As nanotechnology is being used to develop new drugs, FDA is working to ensure quality, safety, and effectiveness | FDA Voice:

"Materials at the nanoscale can have different chemical, physical, or biological properties compared to their conventionally-scaled counterparts. Scientists can use these features to enhance the properties or the quality of a drug. But because such properties can affect the quality, safety, or effectiveness of a drug, FDA is studying these issues related the use of this powerful new technology in medical products."

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Thursday, October 10, 2013

Does The Government Shutdown Impact FDA Inspections?

How Does the Government Shutdown Impact FDA Inspections? | FDAzilla Blog:

"Nonetheless, in no way does this mean to let down your guard.

When we get in the inspections data, we’ll have a clearer picture of what’s really going on. As you can see, the FDA is definitely already on pace for a slower year in terms of inspections and 483s."

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Friday, October 4, 2013

FDA Running At Reduced Capacity - Government Shutdown

Government Shutdown Leaves FDA Operating at Reduced Capacity, But User Fees Act as Agency Savior:

" . . . Steven Immergut, another FDA spokesman, who elaborated on the practical effects of the shutdown.

The facts and figures are stark: 45% of the agency's staff is not permitted to work until funding is provided. Nearly 75% of FDA staff remaining on the job are funded through industry-paid user fees, otherwise they would likely be furloughed as well. It was not immediately clear if they would receive pay at the usual intervals."

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