Enrollment Period: 6 months.
Average Learning Time: ~60 minutes.
Additional Resources: Supplemental materials/activities.
Accredited Program: 0.1 CPD Credits.
Method of Training: Online / Self-paced eLearning.Accessibility: 24/7 access to all program materials.
Catalog: Good Manufacturing Practice (cGMP).
Demonstration: Five (5) free trial courses are available.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).
Price: $199.00 USD
Document 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 Devices
Training Provided By: Biopharma Institute
Schedule: Self-paced. Immediate access to training materials 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 course and successfully pass an online, multiple-choice final assessment within a 6-month period, or a 12-month period for professional certification programs. 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.
Who Should Take This Course?
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
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
Change Management and Risk Control
Chapter 7: Procurement (Articles 39 - 44)
Suppliers and Procurement Requirements
Chapter 8: Manufacturing Management (Articles 45 - 55)
Manufacturing Procedures and Quality Control
Cleaning and Environmental Monitoring
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)
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 training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
- Self-paced courses: 24/7 access to individual courses for 6 months and 1 year for professional certification programs.
- Expertise: All courses have been developed by subject matter experts (SMEs) in the area of material being taught.
- Current and validated: All courses are current with respect to regulations and procedures, and are 3rd party validated and/or accredited.
- Optimized for learning: Courses include voiceovers, easy navigation, case studies, progress checks, and high-quality animations to increase retention of subject matter.
- Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for malware to deliver optimal level of security and performance.
- Purchase orders (POs): If issuing 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.
- Reimbursement: Some employers may reimburse for training expenses. Check 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.
- Flexible final assessments: Assessments include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
- Career advancement: Professional certifications help demonstrate your interest and dedication to your career and job performance. They may be helpful for those seeking a new career or transitioning to different positions within their organization.
- Direct access to certificates: Certificate of completion is instantly available once requirements have been fulfilled.
- Verification of training: Certificates can be verified online, and digital badges are issued for all professional certification programs.