The Fundamentals of Good Manufacturing Practices
Description:
Good Manufacturing Practices are followed by life science companies to ensure that the products manufactured meet specific requirements for safety, identity, strength, purity, and quality.
Good Manufacturing Practices are designed to minimize the risks involved in life sciences manufacturing that cannot be eliminated through testing of the final product. In this course, you’ll learn about good manufacturing practices across the entire product lifecycle.
Curriculum for this course:
Welcome
| Course Introduction | 45 secs |
Good Manufacturing Practices
| What are Good Manufacturing Practices? | 1 min 2 secs |
| The Importance of GMP | 45 secs |
| Consequences of Non-compliance | 30 secs |
| Regulatory Framework | 30 secs |
| Key Elements of GMP | 1 min 30 secs |
GMP Day-to-Day Operations
| Pre-Manufacturing | 15 secs |
| At HQ | 45 secs |
| In the Warehouse | 35 secs |
| In the Manufacturing Facility | 1 min |
| Production and Release | 10 secs |
| Manufacturing | 45 secs |
| Manufacturing QA | 10 secs |
| Commercial Distribution | 20 secs |
| Quality Systems | 30 secs |
| QC | 40 secs |
| Manufacturing, Science and Technology | 15 secs |
| Validation and Automation | 40 secs |
| Facilities and Engineering | 25 secs |
Conclusion
| What We Covered | 40 secs |
| Test Your Knowledge | |
| Results | 10 secs |
Revision History
| Major: This course has been redesigned. The redesign includes new learning objectives to align with updated content, as well as a new exam for those objectives. The visual design has been updated as well. | V2.0 |
| Thank you slide removed | V1.3 |
Author:
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General Info:
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CEU Credits: 0.1 -
Course code: ELM-219 -
Duration: 13 mins -
Skill Level: Basic -
Language: English, Spanish, Japanese, Chinese, German, Portuguese, Italian, French -
Final Exam: Yes -
Certificate of Completion: Yes -
version: V2.0 -
Effective Date: 12/02/2024
Related courses:
cGMP – Cases from History and the Regulations
Course code: ELM-201
Private: An Introduction to Good Manufacturing Practices (cGMP)
Course code: ELM-722
cGMP – Equipment, Validation, Complaints and Self Inspection
Course code: ELM-203
Good Laboratory Practices: History and Regulatory Compliance
Course code: ELM-101
21 CFR Part 211 Subpart F: Production and Process Controls
Course code: ELM-208
21 CFR Part 211 Subpart J – Records and Reports
Course code: ELM-210
21 CFR Part 211 Subpart C – Building and Facilities
Course code: ELM-205
21 CFR Part 211 Subpart G: Packaging and Labeling Control
Course code: ELM-209
21 CFR Part 211 Subpart H – Holding and Distribution
Course code: ELM-207
Good Documentation Practices – General Rules of Data Integrity
Course code: ELM-501
Good Documentation Practices (GDocP) and Data Integrity
Course code: ELM-104
Good Documentation Practices – Logbook Data Integrity
Course code: ELM-503
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