Module #1
- Quality Management System overview (QMS) & GMP
Mudule #2
- Elements of Quality Management System
Module #3
- Requirements for registration and approval of generic products for USFDA (ANDA), EU/AU/SA (Dossier), and TPD (ANDS)
Module #4
- Scale-up post approval changes (SUPAC) and variations
Module #5
- Qualification and Validation
Module #6
- Vendor Management
Module #7
- In-process checks during Manufacturing
Module #8
- Case Studies
#1
- For each program batch size is minimum 15 students.Once the registration is complete, the exact date of starting classes will be communicated one week in advance through phone and e-mail.
#2
- Fees for each program is Rs. _______. Student can secure admission maximum two different program at same time.
#3
- Training shall be provided on-line for theoretical study and practical training shall be provided at actual site (at various industries) for 1 week to 2 weeks
#4
- After completion course, we will assist for searching the job and placement