Length: 2 Days
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Fundamentals of FDA Inspection Readiness Training by Tonex

FDA Cybersecurity Premarket Workshop

This course equips participants with the knowledge and skills necessary to prepare for and manage FDA inspections. It covers regulatory requirements, best practices, and strategies to ensure compliance and readiness for inspections in the pharmaceutical, biotechnology, and medical device industries.

Learning Objectives:

  • Understand FDA inspection processes and requirements.
  • Prepare documentation and facilities for inspection.
  • Develop effective communication strategies for interacting with FDA inspectors.
  • Identify and address potential compliance issues.
  • Implement corrective and preventive actions.
  • Maintain a state of continuous inspection readiness.

Audience:

  • Quality assurance professionals
  • Regulatory affairs specialists
  • Compliance officers
  • Pharmaceutical and biotech professionals
  • Medical device industry staff

Program Modules:

Module 1: Introduction to FDA Inspections

  • Overview of FDA and its role
  • Types of FDA inspections
  • Inspection process and timelines
  • Common triggers for FDA inspections
  • Rights and responsibilities during an inspection
  • Case studies of FDA inspections

Module 2: Preparing for an FDA Inspection

  • Pre-inspection preparation checklist
  • Reviewing and updating documentation
  • Facility and equipment readiness
  • Staff training and awareness
  • Mock inspections and audits
  • Developing an inspection readiness plan

Module 3: Conducting the Inspection

  • Roles and responsibilities during an inspection
  • Interacting with FDA inspectors
  • Managing inspection logistics
  • Handling requests for documents and information
  • Managing interviews and facility tours
  • Maintaining inspection records

Module 4: Responding to Inspection Findings

  • Understanding inspection outcomes
  • Types of inspectional observations (Form 483, Warning Letters)
  • Developing a response strategy
  • Root cause analysis of findings
  • Implementing corrective and preventive actions (CAPA)
  • Communicating with the FDA post-inspection

Module 5: Post-Inspection Activities

  • Reviewing and assessing inspection findings
  • Updating policies and procedures
  • Continuous improvement and training
  • Maintaining documentation and records
  • Preparing for follow-up inspections
  • Case studies of post-inspection responses

Module 6: Regulatory Trends and Best Practices

  • Emerging trends in FDA inspections
  • Best practices for maintaining compliance
  • Leveraging technology for inspection readiness
  • Industry benchmarks and standards
  • Learning from regulatory enforcement actions
  • Future outlook for FDA inspections

 

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