FDA Requirements for the Pharmaceutical Industry: Inspection, OTC Drugs, IND/NDA/ANDA, eCTD and GMP Requirements

FDA Requirements for the Pharmaceutical Industry: Inspection, OTC Drugs, IND/NDA/ANDA, eCTD and GMP Requirements 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 brings together:

  • Quality Assurance
  • Regulatory Affair
  • Compliance
  • Quality Control
  • Scientist
  • Manufacturing
  • Engineer
  • R&D
  • Risk
  • Product Development

Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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