FDA Requirements for the Pharmaceutical Industry: Inspection, OTC Drugs, IND/NDA/ANDA, eCTD and GMP Requirements 2017 is a seminar that covers topics such as:
- New Drug Application (NDA)
- Over-the-Counter (OTC) Monographs
- Product Development Overview
- Abbreviated New Drug Application (ANDA)
- Amendments and Supplements to Applications
- Concepts in Clinical Trials and Bioequivalence Trials
- CGMPs and FDA Inspections
- Analytical Method and Process Validation
FDA Requirements for the Pharmaceutical Industry: Inspection, OTC Drugs, IND/NDA/ANDA, eCTD and GMP Requirements 2017 brings together:
- Quality Assurance
- Regulatory Affair
- Compliance
- Quality Control
- Scientist
- Manufacturing
- Engineer
- R&D
- Risk
- Product Development