Pharmaceutical cGMP, Data Integrity and FDA Inspections – Current Challenges and Preparations 2016

  • 29-30 Sep 2016
  • The LaLit Mumbai, India

Description

Topics
  • CGMP for APIsBuildings & Facilities, Equipment, Control of Components
  • CGMP for Finished Pharmaceuticals
  • Documentation, Change Control, Process Validation
  • Production and Process Controls, Laboratory Controls
  • Data Integrity
  • Quality Protocols
  • FDA Inspection Guides
  • Electronic Records and Signatures
  • Recent FDA Warning Letters
  • Top 10 most common cited FDA Inspectional Observations (cGMP deficiencies)
  • Indian Pharma and Challenges Ahead
Who should Attend

Attendees involved or interested in:

  • Quality Control & Quality Assurance
  • A must attend seminar for professionals in Pharmaceutical development and quality control companies, Manufacturers of drug substances (APIs), Finished Products, Contract laboratories and Clinical Research Organizations
  • Regulatory Compliance
  • Research and Development Engineering
  • Validation Production
  • Manufacturing and Facilities
  • Documentation Supply Chain and Logistics

Past Events

Important

Please, check "Pharmaceutical cGMP, Data Integrity and FDA Inspections – Current Challenges and Preparations" official website for possible changes, before making any traveling arrangements

Event Categories

Government & Global Issues: Law & Regulations
Health & Medicine: Pharma
Science: Life Sciences & Biology

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