21 CFR 211: cGMP for Finished Pharmaceuticals Online Training Course
€1125.00
€1125.00
Self-paced elearning
Quiz
Allow 6 - 7 hours hours to complete the course. Learning times vary dependent on the learner’s preferred pace.
Closed Captions
Basic (a very basic knowledge of the topic but no professional usage)
6 months, 24/7 access
A certificate of completion will be issued on successful course completion.
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?
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.