FDA Quality System Inspection Technique (QSIT) Audits – Good Preparation Practices

FDA Quality System Inspection Technique (QSIT) Audits – Good Preparation Practices is a webinar that covers topics such as:

  • Major considerations in the regulatory requirements for:
  • Unique QSIT Subsystems and assessment process
  • Latest GMP regulations for medical devices
  • How to lay a strong foundation for fulfilling FDA’s QSR
  • Preparing and Executing Audit Proof Quality System
  • Recent findings by FDA 483s and more serious warning letters
  • Unannounced FDA audit Readiness
  • Challenges in maintaining the promises made in your response letter to FDA
  • Essential components of a well-documented quality system
  • How to perform a risk-based mock QSIT assessment

FDA Quality System Inspection Technique (QSIT) Audits – Good Preparation Practices is intended for:

  • Manufacturing Departments
  • A must attend webinar for teams in:
  • Research and Development Departments
  • Process Engineering
  • Quality Assurance Departments
  • Design Assurance Departments
  • Quality Engineers
  • Quality Control Departments
  • Sterilization and Production Cleanroom maintenance Teams
  • CAPA Coordinators
  • Regulatory Departments
  • Document Control Departments

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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