CEU Credits: 0.1
Course Code: ELM-806
Duration: 45 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.0
Curriculum for this course
Overview
Course Introduction
Course Objectives
CFR, ICH and The FDA
Challenges Facing the Medical Device Industry
Single User License
Purchasing
Purchasing Process – Conforms to Specified Purchasing Information
Purchasing Process – Key Areas
Purchasing Process – Analysis
Purchasing Process – Materials
Purchasing Information - Documented
Purchasing Information – Quality Agreement
Verification of Purchased Product – Inspection Process
Verification of Purchased Product – Labeling
Verification of Purchased Product – Inspection
Production and Service
Control of Production and Service Provisions
Cleanliness of Product – Work Environment & Sterile Products
Cleanliness of Product – Specific Requirements
Installation Activities
Installation Activities – Implantable
Servicing Activities
Servicing Activities Vs Complaints
Particular Requirements for Sterile Medical Devices
Validation of Processes for Production and Service Provisions – Intended Purpose
Validation of Processes for Production and Service Provisions – Validation Vs Qualification
Validation of Processes for Production and Service Provisions – IQ/OQ
Validation of Processes for Production and Service Provisions – PQ
Validation of Processes for Production and Service Provisions – Protocols
Validation of Processes for Production and Service Provisions – Lifecycle
Particulate Requirements for Validation of Processes for Sterilization and Sterile Barrier Systems
Sterility Assurance Level (SAL)
Identification – Part Numbering System
Identification – General Rules
Identification – Easily Identified
Identification – Quality Unit
Traceability – Lot/Serial Numbers
Traceability – Few Common Mistakes
Traceability – Product Order Number
Traceability – Implantable
Customer Property
Preservation of Product – Procedures
Preservation of Product – Shipping
Preservation of Product – Environmental
Preservation of Product – Stability Studies
Preservation of Product – Accelerated Study
Preservation of Product – Closed/Open Containers
Control of Monitoring and Measuring Equipment
Control of Monitoring and Measuring Equipment – Inspection
Control of Monitoring and Measuring Equipment – Unique Number
Control of Monitoring and Measuring Equipment – ISO Standard
Control of Monitoring and Measuring Equipment – ISO 17025
Control of Monitoring and Measuring Equipment – Calibration
Control of Monitoring and Measuring Equipment – Software
Control of Monitoring and Measuring Equipment – Shutdowns
Conclusion
Final Assessment
Certification
