CEU Credits: 0.1
Course Code: ELM-147
Duration: 45 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.0
Curriculum for this course
Course Overview
Learning Objectives
Who Should Take This Course?
Terms Explained
Course Modules
Introduction to Manufacturing Considerations
Pre-market Changes to Manufacturing Process
Post-market Changes to Manufacturing Process
GMP Considerations for Combination Products
cGMP Regulations: Individual Approach
cGMP Regulations: Hybrid/Streamline Approach
Additional 21 CFR 820 Specified Provisions – Part 1
Additional 21 CFR 820 Specified Provisions – Part 2
Case Studies
Case Study: Prefilled Syringe (PFS)
Case Study: Drug-Coated Mesh
Case Study: Drug Eluting Stent (DES)
Introduction to Post-Market Safety Reporting
Consolidation of Requirements
Who is subject to the Combination Product PMSR final rule?
Combination Product PSMR Final Rule Example
Safety reporting requirements for Combination Product and Constituent Part Applicants
Reporting requirements for BOTH Combination Product Applicants and Constituent Part Applicants
Constituent part-based reporting requirements apply ONLY to Combination Product Applicants
Information sharing requirements apply ONLY to Constituent Part Applicants
Combination Product PMSR Requirements by Application and Product Type (PMSR – Appendix 1)
Conclusion
Final Assessment
Certification
