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:   Global MDR, Indian MDR – 2017; USFDA; CE Certification; ISO 14971:2019; ISO 13485:2016; MDSAP 

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

Course Fee: 

For Indian Nationals:

 INR 30,000 (Including GST); this fee covers Training Fee INR 24,500/- + Assessment Fee INR 4,500)

For Foreign Nationals:

USD 400; this fee covers Online Training Fee USD 275 + Assessment Fee USD 125

Discount available to AMTZ Manufactures; AiMeD Members, UdaiMeD Members, CII Members, PWMAI Members & IBSC Partners/Alumni 

Last Date for Registration 15th April 2024