Admission Open

Online Training Program

Certificate in Biomedical Quality Assurance

(NSDA Approved Course; Job Role No: 2019/HLT/AMTZ/3578)

Admission Open

 The objective of this training program is to develop a pool of workforce which can be employed by focuses on the acquisition of skills necessary to develop quality control of medical devices and validation process. As per the training modules at the end of the training, the candidate would be certified to perform following activities

• Works cooperatively with R&D, Process Development, Quality, Production, Regulatory, Equipment Engineering, Supply Chain, and Marketing to ensure project success.
• Prepares standard reports/ documentation to communicate results to the technical community.
• Responsible for developing appropriate test methods and inspection plans. Test methods shall be validated as necessary.
• Ensures quality products are developed in accordance to governing regulations and processes.
• Actively participate and assist teams with Risk Analysis to include Risk Assessments.
•  Responsible for product change assessments, health hazard evaluations and product recall documentation.
   

MODULES:

·       Medical Device Quality and Regulatory Fundamentals

·       Risk Management & Risk Analysis

·       Medical Technology Quality Systems

·       Design Control & Product Development

·       Design verification, Validation, clinical evaluation and CAPA

Duration: 50 Hours (Sessions on Every Saturday 6:00 PM – 09:00 PM Indian Standard Time)

Course Fee: 

For Indian Nationals:

 INR 19,500 (Including GST); this fee covers Training Fee INR 15,000/- + Assessment Fee INR 4,500

For Foreign Nationals:

USD 375; this fee covers Online Training Fee USD 250 + Assessment Fee USD 125