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

Description

Prescription and Over-the-Counter GMPs: Avoiding FDA Form 483 and Making the Best Decisions is a webinar that covers topics such as:

  • 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

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

  • Quality Assurance
  • Regulatory Affairs
  • Compliance
  • Quality Control
  • Scientists
  • Manufacturing
  • Engineers
  • R&D
  • Risk Management
  • Product Development

Future Events

Prescription and Over-the-Counter GMPs: Avoiding FDA Form 483 and Making the Best Decisions 2020

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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