Combination Products (Drugs, Devices and Biologics) – Part 3
Curriculum for this course:
Introduction
| Course Overview | 1 min 01 secs |
| Learning Objectives | 1 min 09 secs |
| Who Should Take This Course? | 1 min 11 secs |
| Terms Explained | 50 secs |
| Course Modules | 52 secs |
Module 5: Manufacturing and GMP Considerations
| Introduction to Manufacturing Considerations | 1 min 35 secs |
| Pre-market Changes to Manufacturing Process | 1 min 09 secs |
| Post-market Changes to Manufacturing Process | 1 min 08 secs |
| GMP Considerations for Combination Products | 58 secs |
| cGMP Regulations: Individual Approach | 1 min 20 secs |
| cGMP Regulations: Hybrid/Streamline Approach | 1 min 02 secs |
| Additional 21 CFR 820 Specified Provisions – Part 1 | 1 min 07 secs |
| Additional 21 CFR 820 Specified Provisions – Part 2 | 1 min 10 secs |
| Case Studies | 1 min 09 secs |
| Case Study: Prefilled Syringe (PFS) | 1 min 14 secs |
| Case Study: Drug-Coated Mesh | 1 min 30 sec |
| Case Study: Drug Eluting Stent (DES) | 1 min 30 secs |
Module 6: Post-Market Safety Reporting
| Introduction to Post-Market Safety Reporting | 1 min 12 secs |
| Consolidation of Requirements | 56 secs |
| Who is subject to the Combination Product PMSR final rule? | 1 min 55 secs |
| Combination Product PSMR Final Rule Example | 1 min 25 secs |
| Safety reporting requirements for Combination Product and Constituent Part Applicants | 1 mins 11 secs |
| Reporting requirements for BOTH Combination Product Applicants and Constituent Part Applicants | 1 min 38 secs |
| Constituent part-based reporting requirements apply ONLY to Combination Product Applicants | 1 min 30 secs |
| Information sharing requirements apply ONLY to Constituent Part Applicants | 1 mins 31 secs |
| Combination Product PMSR Requirements by Application and Product Type (PMSR – Appendix 1) | 1 min 14 secs |
Conclusion
Final Assessment
Certification
Author:
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General Info:
-
CEU Credits: 0.1 -
Course code: ELM-147 -
Duration: 45 mins -
Skill Level: Intermediate -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes
Reviews:
This is a must do program for anyone who needs to understand how 21 CFR 210/211 and 21 CFR Part 820 apply to combo products.
The GMP considerations to combo products are very real, if you are only aware of the medical device regs I would highly recommend doing this course.
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