General Drug or Pharmaceutical cGMP and Quality Systems

Content
6 modules

Rating

Course Length
6 hours

Instructor
NSF Learning

Price
$350.00

Description

This self-paced learning course provides comprehensive instruction on the general drug or Pharmaceutical cGMP and Quality Systems requirements.   This course utilizes real-world scenarios to instruct on the practical application of these requirements, embedded video and audio content, engaging knowledge checks throughout each module, and a final competency assessment.

The program is presented in three modules: - approximate course completion time = *5 hours

1. Introductory Topics – approximately 1 hour

Provides the history of GMPs and Basic Food and Drug Law to include discussion about USP, NF, Code of Federal Regulations, the FDA and the FD&C act.  This section also outlines basic concepts of Pharmaceutical Quality Systems and GMPs, explaining basic principles of a Quality Management Systems in relationship to the commercial product lifecycle.  In this section, students will also learn the importance of quality integration and basic concepts of GxPs and QMS principles and the seven principles in pharmaceutical manufacturing throughout the lifecycle of each product.

2. Intermediate Topics – approximately 2.5 hours

This section includes instruction on: Quality Culture, Quality Systems, People, Data Integrity, Documentation and Records, Elements of Procedure and GMP, Fundamental of GDP Requirements, Materials Management Controls, Change Management, Change Control and Continuous Improvement.  

3. Advanced Topics – approximately 1.5 hours

This section includes instruction on: Quality Risk Management, Measuring Success: GMP, Audits and Self Inspection, Batch Release System, Deviation and Human Error, Complaints, Quality Defects and Recalls. 

 

*Time is approximate and based on the amount of content included in each section. Content is self-paced, driven by the learner.

Certificate

By completing/passing this course, you will attain the certificate Pharma Certificate

1.
Introduction Notes
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General Drug or Pharmaceutical cGMP and Quality Systems Introduction Program
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3.
Intermediate Notes
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General Drug or Pharmaceutical cGMP and Quality Systems Intermediate Program
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5.
Advanced Notes
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General Drug or Pharmaceutical cGMP and Quality Systems Advanced Program
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Added 5 months ago, by Christopher
 
Added 6 months ago, by Thom
 
Added 9 months ago, by Bradley
Excellent course for understanding GMP quality department.
 
Added 9 months ago, by Chelsey
 
Added 10 months ago, by Anonymous
 
Added about 1 year ago, by Shuhua
It's a well-designed course that covers all aspects of Quality Systems, and cGMP knowledge. What I like the most is the real NSF directors' sharing their expertise in different videos.
 
Added about 2 years ago, by Mark
 
Added about 3 years ago, by Andrew
 
Added about 3 years ago, by Niloofar
 
Added over 3 years ago, by John Paul
Great course! Very helpful!

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