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 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

Last Date for Registration 18th August