GMP: China Food and Drug Administration (CFDA) - GMP for Medical Devices
 | Enrollment Period: 12 months. Average Learning Time: ~60 minutes. Additional Resources: Supplemental materials/activities. Accredited Program: 0.1 CPD Credits. Method of Training: Online, asynchronous, self-paced eLearning. Accessibility: 24/7 access to all program materials. Catalog: Good Manufacturing Practice (cGMP).Demonstration: Five (5) free trial courses are available. Group/Employee Training: Click here to request a quote. Final Assessment: Multiple choice; unlimited attempts. Certificate: PDF with validation code (See sample). Price: $199.00 USD |
Download Program DetailsDocument your dedication to quality, compliance, safety, and job performance by earning a training certification.Training Program: GMP: China Food and Drug Administration (CFDA) - GMP for Medical DevicesTraining Provided By: Biopharma Institute Website: https://www.biopharmainstitute.com Schedule: Self-paced. Immediate access to training materials upon enrollment. Description:  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 course and successfully pass an online, multiple-choice final assessment within a 12-month period. A certificate of completion is immediately accessible in PDF format after satisfying the requirements. Biopharma Institute certificates and digital badges include the date of completion, but do not have an expiration date. However, compliance training is typically considered valid for a period of 3 years. Many organizations suggest that compliance training should be refreshed at least every three years to stay up to date with regulations, standards, guidelines, and to reinforce the importance of maintaining compliance. The validity period for employee compliance training would be determined by those responsible for managing quality assurance. Biopharma Institute's online training courses include immediate access after enrollment. Username, password, and instructions are emailed to the student directly following online enrollment into the program. Course takers may attempt the final assessment any number of times, as needed, to achieve a passing score. The certificate of completion is instantaneously launched and made available to the student in a PDF format upon completion. Once all training requirements have been satisfied the achievement can be verified from our website using the unique ID code found on the certificate. Professional certification programs issue a digital badge to verify training and document the achievement. These digital badges can be displayed on social networking sites, such as LinkedIn, Facebook, Twitter, and Badgr. |
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) | Objectives:Skill Level: Intermediate This training program has been developed to train employees with Intermediate Knowledge of China CFDA - GMPs. | |
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: | Certificate of completion is instantly available once requirements have been fulfilled. |
| Verification of training: | Certificates verifiable online with digital badges 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. |
