This Get to know the FDA Online Training Course course will  cover topics that will help you understand the role of the Food and Drug Administration (FDA).

The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.

FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.

The FDA’s primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C), but the agency also enforces other laws.

In addition to learning about the different enforcement actions the FDA can use the learner will gain knowledge of the 483 observations for FY2021. This provides an unique insight to learn about enforcement in practice. 

Who should take this course?

• QA personnel responsible for the design and implementation of Quality. Management Systems to comply with FDA QSR requirements.
• QA personnel with responsibility for Quality Audit programmes.
• Manufacturing & Process Engineers responsible for FDA Quality System Regulation (QSR) compliance.
• All personnel who interact with the FDA in their organisation.
• Personnel at all levels involved in FDA inspections.

1. Gain an understanding of the FDA’s history.

2. Learn the key events that led to the setting up of the FDA.

3. Gain an understanding of the Federal Food, Drug , and Cosmetic Act (FD&C Act).

4. Gain an understanding of the different types of enforcement acts the FDA can implement when cGMPs are violated.

5. Gain an insight into form 483s 21 CFR 820 observations that were made in FY2021. 

The following topics will be covered in this course:

• History of the FDA
• Key events that led to the setting up of the FDA
• The Federal Food, Drug , and Cosmetic Act (FD&C Act)
• cGMP FDA enforcement actions
• Warning letters
• FT 2021 483s
• Consent decree

Supplemental Material:

1. You will be supplied with links to important FDA regulations that are relevant to the medial device and pharmaceutical industries. 
2. A link to all form 483 observations for FY2021 will be supplied.
3.  

Assessment:

There will be an end of course quiz.

Upon completing the course and when you obtain a passing grade on your final quiz (80% or over), you will receive a PDF certificate to show that you have completed all the course content. 

Dr. Fiona Masterson 

Fiona is the founder of The Learning Reservoir. She has 25+ years of parallel paths in quality management, operations management and education. She has broad technical expertise encompassing quality systems compliance, quality standards implementation, regulatory affairs and operations management. She has worked in start-ups and high‐tech, fast paced manufacturing environments. She lectures part-time in technical universities on subjects related to her industrial expertise.

Fiona has Bachelor and Masters of Science degrees, and a Doctorate in Mechanical Engineering. Her Doctorate focused on innovative drug/device combinations products. Fiona is a certified lead auditor. Fiona has published in peer reviewed journals on topics such as medical device and pharmaceutical regulatory affairs, on-the job training and innovative training technologies and strategies.

She writes many of The Learning Reservoir’s blog posts and invites you to connect with her on LinkedIn.