An Alternative To The Free Online GCP Training by Quintiles

• People also need recommended FDA GMP online training courses offered by SkillsPlus International Inc.

Free Online GCP Training

Updated 4/10/2015:

The Quintiles GCP training is no longer available to the public for free.

I recently discovered a free, publicly accessible GCP training program that might be of interest to you: The Good Clinical Practice (GCP) course, offered by the National Drug Abuse Treatment Clinical Trials Network

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Free Online GCP Training | Clinical Research Learning Blog:  'via Blog this'

Upon completion of the program the participant will be able to:

1. Describe the ICH Good Clinical Practice (GCP) and local regulatory guidelines for good clinical practice in the conduct of clinical trials 
2. Discuss the investigator’s responsibilities in the conduct of clinical trials at the clinical site 
3. Apply ICH and local regulations to specific research activities at the clinical site

Free is good!

Quintiles helps pharmaceutical, biotechnology and medical device companies develop and market innovative therapies. Quintiles is also a full sized CRO and has its operations over more than 40 countries world wide.  

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• PDA FDA - Interesting Manufacturer Statistics (skillsplusinfo.blogspot.com)

GxP Means . . .

• cGMP FDA GMP Training Courses by SkillsPlus International Inc.

Updated: November 6, 2016.

Some links don't age well, like the one in the original post below.

Instead, you might interested in:

ISPE Glossary of Pharmaceutical and Biotechnology Terminology

- - - - -

For those who aren't quite sure what this acronym means, Nancie Celini explains what it is and the implications for GxP training in her blog post on the GxP Perspectives blog, GxP Defined: Training for FDA Regulated Industry.

The post is wonderfully packed with information and is succinctly written.

You might also be interested in basic cGMP/QSR training:
Essentials for Pharmaceutical Manufacturers - cGMP Training
Essentials for Medical Device Manufacturers - QSR Training

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SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog

FDA GCP - Tips On Conducting non-US Studies

If you're looking to conduct clinical studies outside the U.S., you might do well to read this superb article from Bruce Mackler on GEN, "Spotlight on the FDA Outsourcing Clinicals; Medical Journal Articles; and Contract Manufacturing Liability Issues. Mackler says, "In today’s financing environment, the absence of early clinical data presents a high barrier to obtaining funding. Investors often say “show me the clinical data that show that the drug is safe and works and I will show you my money.” As a result, biopharma companies have moved into early non-U.S. clinical trials that have lower safety data burdens. These studies are being conducted in less wealthy (a.k.a., developing) countries, where Phase I trials can be more rapid and less costly. This strategy has been promoted by CROs established in these countries." The article provides some great tips, not to be overlooked. 

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Medical Device Sponsors - FDA Trends and Tips To Avoid 483s

Updated November 5, 2024

The original link broke

You might also be interested in this article by the same author, Carl Anderson:

The FDA 483 - https://carl1anderson.wordpress.com/wp-content/uploads/2009/03/the-fda-483.pdf

---  the original post follows below  ---

The Division of Bioresearch Monitoring, Office of Compliance, Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration, released inspection statistics for the 2007 fiscal year. The statistics for the 40 Bioresearch Monitoring (BIMO) inspections of medical device sponsors showed serious concerns for compliance with good clinical practice (GCP) regulations. Author Carl Anderson explains the CDRH findings, identifies problem areas to avoid, and gives tips on how to avoid 483s, in his article, "Trends in FDA CDRH Bioresearch Monitoring Inspections." The following are the topics he covers in the article . . .

• About the Division of Bioresearch Monitoring Organization at CDRH
• Medical Device Sponsor Inspections
• Quality Systems in Clinical Trials
• Implications of BIMO Inspection Statistics - with a top 5 category list of deficiencies

Don't get caught flat-footed. Reading this article will help you steer clear of choppy waters, warnings, and 483s.

Related Posts:
More FDA 483 Resources - Comments and Pearls from Validation Online
FDA 483 Inspectional Observations - learn from these examples

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4 Tips To Ensure Your Prescription Safety

Updated March 11, 2021

The original link broke.

People also search for:

Use Medicines Safely - Health.gov

---  original post follows below  ---

It seems as if I'm reading news everyday about some drug safety issue. Here are 4 great tips that you can personally act upon, in order to enhance the safety of prescriptions. For the full details, read this Reader's Digest article, "Prescription Drug Precautions - After a trend in recalled drugs, people are losing faith in the FDA. Find out how to ensure the safety of your prescriptions." In a nutshell, here are the 4 tips at a very high level . . .

1. Consider enrolling in a clinical trial as a volunteer (a kind of civic duty)
2. Stick with medications that have been around 4-5 years (the side effects are better known)
3. Report problems to the FDA
4. Urge legislators to provide greater funding to the FDA

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