Regulatory aspects food and medical devices practical lab Detailed Syllabus for Pharmaceutical Regulatory Affairs M.Pharm first year second sem is covered here. This gives the details about credits, number of hours and other details along with reference books for the course.
The detailed syllabus for Regulatory aspects food and medical devices practical lab M.Pharm 2017-2018 (R17) first year second sem is as follows.
M.Pharm. I Year II Sem
- Checklists for 510k and PMA for US market
- Checklist for CE marking for various classes of devices for EU
- STED Application for Class III Devices
- Audit Checklist for Medical Device Facility
- Clinical Investigation Plan for Medical Devices
- Preparation and submission of medical devices for approval (3 products)
- GMP of manufacturing of medical devices of diverse nature ( 3 products)
- preparation and submission of neutraceuticals devices for approval (3 products)
Practical work shall be carried out based on the theory syllabus
For all other M.Pharm 1st Year 2nd Sem syllabus go to JNTUH M.Pharm Pharmaceutical Regulatory Affairs 1st Year 2nd Sem Course Structure for (R17) Batch.
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