GMP: China Food and Drug Administration (CFDA) - GMP for Medical Devices
 |
|
Download 2024 UPDATE:
This program is currently unavailable for enrollment.
It may have been updated or discontinued.
Check for newer version in our catalog.
This program is currently unavailable for enrollment.
It may have been updated or discontinued.
Check for newer version in our catalog.
.
Browse Our Catalog of 300+ Courses:
Catalog of CoursesEnroll into a Trial Course & Start Learning, Today:
Free Trial CoursesOutline: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) | Objectives:Skill Level: Intermediate This training program has been developed to train employees with Intermediate Knowledge of China CFDA - GMPs. | |
Use our Search Form to Find What You're Looking For:
Benefits of Training with Biopharma Institute
| Immediate access to courses: | Username, password, instructions, and receipt of payment are immediately emailed upon online enrollment. |
| Self-paced, asynchronous eLearning: | 24/7 access to all course materials and assessments for 12 months. |
| Open enrollment: | No prior course prerequisites or work experience required. |
| Expertise: | Courses developed by subject matter experts (SMEs) in the area being taught. |
| Current and validated: | Training is current with respect to regulations, procedures, and 3rd party validated and/or accredited. |
| Optimized for learning: | Courses include voiceovers, easy navigation, reading materials, case studies, progress checks, and high-quality animations to increase retention of subject matter. |
| Secure and safe access: | Encrypted website and LMS connections, firewall, and daily malware scans deliver optimal security and performance. |
| Flexible final assessments: | Multiple-choice questions can be taken repeatedly until a passing score is achieved. |
| Direct access to certificates: | Upon completion, certificates are immediately issued in an encrypted PDF format. Certificates include a watermark, unique validation code, and QR verification barcode. |
| Verification of training: | Certificates are verifiable online using QR barcode or the unique ID code. Digital badges are additionally issued for all professional certification programs. |
| Training manager access: | A proprietary portal offers access to download enrollment reports, training records, account balance, and more. |
| SCORM-compliant courses: | Courses can be delivered directly to most corporate Learning Management Systems (LMS). |
| Purchase orders (POs): | POs are accepted from all companies. Request an invoice when starting the procurement process. |
| Reimbursement: | Some employers may reimburse their employees for training expenses. Check your company's policy. |
| Financial assistance: | Payment plans are available to those who qualify. Alternatively, purchasing individual courses one at a time is also an option. |
| Career advancement: | Professional certifications help demonstrate interest and dedication to career and job performance. They may be helpful for those seeking to grow their career or transitioning to a different position within an organization. Professional certifications are a great addition to a resume, offer talking points for the interview, and practical knowledge for performing duties. |
Have Questions? Contact Us:
Use the form below if you would like more information on our programs. You may want to request a quote on group training or an invoice for generating a company purchase order. For quotes or invoices please provide the course(s) and number of students. Alternatively, call toll-free from the US or Canada: +1 (888) 424-6576. International callers may dial: +1 (201) 301-8370.
