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USFDA Regulatory SUbission Workshop
USFDA Regulatory SUbission Workshop
Join our 2-hour online workshop on Pharmaceutical Regulatory Submission Requirements of the USFDA and gain practical insights into the regulatory pathways for drug approvals.
Topics Covered
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Biologics License Application (BLA)
Prior Approval Supplement (PAS)
Changes Being Effected (CBE)
Drug Master File (DMF)
Annual Reports
Venue
*Re-schedule on 26 July 2026
Old Date: 19 July 2026
Time: 11:00 AM – 1:00 PM
Mode of Delivery
Online Live Session
Speaker
Auditor | Trainer | Consultant
About Speaker
About Speaker
Having 15 years of rich experience in Pharmaceutical, Healthcare, Medical Device, Clinical Research Industry, Associated with Indian Biological Sciences and Research Institute, IGMPI, Panacea Biotec Ltd, Parabolic Drugs Ltd, APCER Life Sciences in Quality Assurance department, Key roles are - QMS, Validation, CAPA, Deviation, Auditing and Training, Compliance , Market Complaint, Product Recalls Handling, SOP maintenance, gap analysis.
Registeration Form
E-Certificate of Participation will be awarded to all participants upon successful completion of the workshop.
Register today and gain valuable knowledge of USFDA regulatory submission requirements from an experienced industry expert.
For Registration & Enquiries
+91 99995 09892 | +91 9410557050 | info@theskillmaster.org
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