In this course 21 CFR 211: cGMP for Finished Pharmaceuticals Online Training Course participants learn about what the fundamental aspects of drug manufacturing. 

Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

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?

• Professionals who work in a cGMP environment (from beginner to advanced professionals).
• Professionals who are packagers, directors, managers, supervisors, engineers,  manufacturing operators, product builders, quality control/assurance engineers and laboratory personnel working in the pharmaceutical manufacturing  industry.
• Internal auditors.
• Those seeking to work in the pharmaceutical manufacturing  industry.

1. Understand drug cGMPs.
2. Explain and define GMP and cGMP.
3. Gain knowledge about where the cGMP regulations came from.
4. Understand what the Food Drug and Cosmetics Act 1938 is.
5. Understand and apply the information on what cGMP regulations must be adhered to in everyday roles and responsibilities within the pharmaceutical manufacturing sector.
6. Gain the knowledge to understand and apply GMP concepts to decision making in a managerial role.
7. Recognize the consequences of failing to comply with CGMP regulations.
8. 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 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

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

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

Supplemental Material:

There be links the relevant parts of 21 CFR 211 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. 

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.