This FDA cGMP Enforcement Actions Online Training Course teaches participants about the enforcement actions that are available to the FDA when there are violations of Current Good Manufacturing Practices (cGMPs).

The objective of FDA regulatory programs is to assure compliance with the Federal Food, Drug, and Cosmetic Act (the Act). Enforcement actions may follow from violations of the Act uncovered by the FDA during Quality System inspections, reports from competitors, and FDA monitoring of industry practices.  The type of enforcement activity the FDA uses will depend on the nature of the violation.

The FDA form 483 observations for FY2021 will be also reviewed. This provides an unique insight for the learner into FDA enforcement actions in practice.

Who should take this course?

• Individuals who are inspected by the FDA and require an understanding of FDA enforcement actions.
• Anyone who wants to learn about the enforcement actions the FDA can take when there are GMP noncompliances are identified.

1. Understand what the Food Drug and Cosmetics Act 1938 is.
2. Recognize the consequences of failing to comply with CGMP regulations.
3. Gain an understanding of the different types of enforcement acts the FDA can implement when cGMPs are violated.
4. Gain an insight into form 483s 21 CFR 820 observations that were made in FY2021.   

Topics covered in this course include:

• Food, Drug, and Cosmetic Act.
• What is “Adulteration”.
• Warning letters.
• Consent decree.
• Seizures.
• Felony convictions.
• Withhold/withdraw product approval.
• There will be a review of form 483 21 CFR 820 observations for FY2021.

Assessment: 

There will be an end of course quiz.

Upon completing any course and successfully achieved 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. 

You will be allowed 3 attempts to pass the quiz. 

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.