GMP: China Food and Drug Administration's (CFDA's) - GMP for Medical Devices (ELM-330)
 | Method of Training: Online / Self-paced eLearning. Credits: 0.1 CPD Credits.Duration: ~60 minutes. Self-paced Training: 24/7 access to course. Enrollment Period: 3 months.  Catalog: Good Manufacturing Practice (cGMP).Demonstration: Try one of our FREE courses. Certificate: View sample certificate. PRICE: USD $199.00 |
Document a dedication to your career and job performance by earning a training certification from Biopharma Institute. Training Program: GMP: China Food and Drug Administration's (CFDA's) - GMP for Medical DevicesTraining Provided By: Biopharma Institute Website: https://www.biopharmainstitute.com Schedule: Self-paced. Immediate access to training materials upon ordering. Description: Online training with immediate access upon enrollment.  This course focuses on providing an understanding of the Chinese Food and Drug Administration's (CFDA's) Announcement on Good Manufacturing Practices for Releasing Medical Devices, 2014 Number 64. These regulations are outlined in 13 Chapters (including 84 separate articles), which will be covered in this course. The purpose of this course is to present the regulations in a clear and concise manner in order to provide participants with the necessary information required to maintain the safety and efficacy of medical devices as specified by the CFDA.
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with passing score within a 90-day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements. |
COURSE OUTLINE:Introduction Overview Who Should Take This Course? Learning Objectives Definitions Introduction to CFDA GMPs for Medical Devices Supplementary Provisions (Chapter 13, Articles 79 - 84) Chapter 1: General Provisions (Articles 1 - 4) General Provisions (Articles 1 - 4) Chapter 2: Institution and Personnel (Articles 5 - 11) Institutional and Executive Management Responsibilities Department Management Responsibilities Personnel Chapter 3: Buildings and Facilities (Articles 12 - 18) Facility Layout and Design Environmental Conditions and Pest Control Warehousing, Storage, and Inspection Chapter 4: Equipment (Articles 19 - 23) Equipment: Intended Use and Operating Procedures Inspection and Calibration Chapter 5: Document Management (Articles 24 - 27) Quality Management System Documents Document Control Procedures Record Control Procedures Chapter 6: Design and Development (Articles 28 - 38) Design Control Procedures Design and Development Input Design and Development Output Validation Change Management and Risk Control Chapter 7: Procurement (Articles 39 - 44) Procurement Control Suppliers and Procurement Requirements Chapter 8: Manufacturing Management (Articles 45 - 55) Manufacturing Procedures and Quality Control Cleaning and Environmental Monitoring Manufacturing Records Inspection, Labeling, Traceability, and Product Protection Chapter 9: Quality Control (Articles 56 - 61) Inspection Instruments and Equipment Product Inspection and Release Procedures Chapter 10: Sales and After-Sales Service (Articles 62 - 66) Chapter 11: Control of Nonconforming Products (Articles 67 - 70) Chapter 12: Adverse Events Monitoring, Analysis, and Improvement (Articles 71 - 78) | COURSE OBJECTIVES:Skill Level: Intermediate This training program has been developed to train employees with Intermediate Knowledge of China CFDA - GMPs. | |
Online Training: The Benefits of Remote Learning & eLearning
- Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
- Optimized for learning: Courses include voice-overs, easy navigation, progress checks, and high-quality animations to increase retention of subject matter.
- Self-paced courses: 24/7 access to individual courses for 90 days, and for professional certification programs for 180 days.
- Flexible final assessments: Assessment testing include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
- Direct access to certificates: Certificate of completion is instantly available once course requirements have been fulfilled.
- Verification of training: Certificates can be verified online, and digital badges are issued for all Professional Certification programs.
- Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's training reimbursement policy.
- Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. You must first request an invoice to be considered. Alternatively, purchasing individual courses one at a time is also an option.
- Purchase orders (POs) accepted: If a PO is required by your company, request an invoice to start the procurement process.
- Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems.
- Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for optimal level of security and performance.
- Career advancement: Professional certifications help demonstrate your interest and dedication to job performance, and may be helpful for those seeking a new career or transitioning to different positions within their organization.
