Prescription and Over-the-Counter GMPs: Avoiding FDA Form 483 and Making the Best Decisions

  • 06 Aug 2019
  • Webinar

Description

Topics
  • Over-the-Counter (OTC) Monographs vs. NDA/ANDA cGMPs
  • Manufacturing, Packaging and Labeling procedures
  • Production and process controls
  • Quality Systems
  • Cleaning procedures
  • Personnel qualifications and responsibilities
  • Packaging and labeling procedures
  • Building and facility maintenance
  • Holding and distribution
  • Equipment validation
  • Recordkeeping
  • Laboratory operations
  • Identity testing
  • Product traceability
Who should Attend
  • Quality Assurance
  • Regulatory Affairs
  • Compliance
  • Quality Control
  • Scientists
  • Manufacturing
  • Engineers
  • R&D
  • Risk Management
  • Product Development

Past Events

Important

Please, check "Prescription and Over-the-Counter GMPs: Avoiding FDA Form 483 and Making the Best Decisions" official website for possible changes, before making any traveling arrangements

Event Categories

Business: Human Resources (HR), Innovations, Internal Audit & Compliance, Quality assurance
Health & Medicine: Healthcare
Industry: Food & Beverages
Science: Engineering
Technology: Information Technology (IT)

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