IPM has been successfully conducting training programmes in Mumbai, with its presence in Dombivli, Borivali & Vashi.
Salient features are:
- Course curriculum based on current approach of regulatory agencies
- Sunday batches, so good option for working professionals
- Experienced industrial faculties
- User-friendly notes based on current guidelines
- Explanation with case-studies
- Group discussion & Quiz sessions
- Evaluation & certification
Eligibility: Pharma/Science graduates and Post-graduates/ Industry working professionals
Duration: 6 months [Sunday batches]
Course Highlights:
Pharmaceutical Quality System, Indian Pharmaceutical Industry
Regulatory Affairs, Overview of GMP,
Registration requirements of USFDA
ICH Quality guidelines
ICH M4 Q CTD format
DMF preparation: Module 2, Module 3
Regulatory Submission to US
- DMF submission, Common deficiencies, Handling changes
Regulatory submission youth arizona cardinals to Europe
- CEP approval, Module 1, 2 & 3
- Addressing deficiencies, Revisions & renewal
- EDMF/ASMF
WHO, Canada, Japan filing procedures
eCTD Submissions