Introduction to FDA 21 CFR Part 211
About Course
This online course outlines the Current Good Manufacturing Practices (cGMP) for pharmaceutical products. Participants will learn key regulatory requirements for drug manufacturing, quality control, and compliance to ensure product safety and efficacy.
Key Topics Covered:
- Overview of cGMP regulations
- Requirements for facilities, equipment, and personnel
- Production and process controls
- Quality assurance and laboratory controls
- Recordkeeping and documentation
Who Should Enroll:
- Production pharmacists
- QA professionals
- Pharmaceutical industry professionals
- Regulatory affairs personnel
- Pharmacy & life sciences students
Course Format:
- Self-paced online modules
- Lifetime access
- Quizzes & certification upon completion
Course Content
Subpart A: General Provisions
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Scope
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Definitions
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
Final Assessment
Earn a certificate
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Student Ratings & Reviews
Informative
Best for us
Nicely structured, easily understanding
Five stars
It was very interesting and fascinating course.