In 1962, Congress instructed the FDA to require that all drugs be produced according to Good Manufacturing Practice (GMP) which should be compliant to FDA 21 CFR Part 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs AND 21 cfr 211  and 21 CFR Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals.

The move was in response to concerns about substandard drug manufacturing practices at the time, such as the use of thalidomide, a drug used in Europe to treat morning sickness, which was found to cause birth defects. The 1962 Drug Amendments brought modern quality assurance and control principles to drug manufacturing. The word “current” was later added to make it “CGMP” (or cGMP) to imply that the regulation allows for changing technology in attaining GMP.

In this online course you will learn about the cGMP requirements contained within 21 CFR 210 and 21 CFR 211. You learn how cGMP is a system for ensuring that products are consistently produced and controlled according to quality standards.

The FDA requires employees, contractors, and consultants supporting FDA cGMP activities to have sufficient education, training, and experience to perform their assigned functions.  

Taking this online  training course will help improve personnel knowledge and skills on cGMP requirements.

Who should take this course?

• Those who work in a cGMP environment (from beginner to advanced professionals).
• All employees, contractors, consultants, and suppliers currently supporting or wanting to support FDA cGMP regulated activities.
• those whose roles and responsibilities require they understand and apply cGMP quality principles to their job.
• Professionals who wish to work in the pharmaceutical manufacturing sector. 

1. Understand drug cGMPs.
2. Gain knowledge about where the cGMP regulations came from.
3. Understand what the Food Drug and Cosmetics Act 1938 is.
4. Explain and define GMP and cGMP.
5. Have knowledge of the content and structure of 21 CFR 210.
6. Gain knowledge of terms used in 21 CFR 210.
7. Have knowledge of the content and structure of 21 CFR 211.
8. Gain knowledge of each section of 21 CFR 211.
9. Understand and apply the information on what cGMP regulations must be adhered to in everyday roles and responsibilities within the pharmaceutical manufacturing sector.
10. Gain the knowledge to understand and apply GMP concepts to decision making in a managerial role.
11. Recognize the consequences of failing to comply with CGMP regulations.
12. Gain knowledge about what types of cGMP violations appear in FDA warning letters.

The following topics will be covered in this course:

(a) A review of all of the sections of 21 CFR 210.

(b) A review of all of the sections of 21 CFR 211:

Subpart A – General Provisions

Subpart B – Organization and Personnel

Subpart C – Buildings and Facilities

Subpart D – Equipment

Subpart E – Control of Components and Drug Product Containers and Closures

Subpart F – Production and Process Controls

Subpart G – Packaging and Labeling Control

Subpart H – Holding and Distribution

Subpart I – Laboratory Controls

Subpart J – Records and Reports

Subpart K – Returned and Salvaged Drug Products

(c) A discussion on the practical application of the cGMP regulations.

(d) Warning letters that document cGMP violations will be reviewed throughout the course.

Supplemental Material:

Links to the relevant parts of 21 CFR 210 and 211 will be shared throughout the course. 

Assessment:

There will be a quiz at the end of the course.

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. 

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.