FDA Requirements for the Pharmaceutical Industry: Inspection, OTC Drugs, IND/NDA/ANDA, eCTD and GMP Requirements 2017

  • 15-16 Jun 2017
  • Jersey City, NJ, United States

Description

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

Past Events

Important

Please, check "FDA Requirements for the Pharmaceutical Industry: Inspection, OTC Drugs, IND/NDA/ANDA, eCTD and GMP Requirements" official website for possible changes, before making any traveling arrangements

Event Categories

Government & Global Issues: Law & Regulations
Health & Medicine: Pharma

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