IBSC – Online Training Program Certificate in Biomedical Quality Assurance
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)