This FDA Inspection training will examines the audit process and how to manage Process Deviation Investigations.
Inadequate failure investigations continue to be a major GMP deficiency cited during routine and for-cause U.S. Food and Drug Administration (FDA) inspections.
Inadequate failure investigations continue to be a major GMP deficiency cited during routine and for-cause U.S. Food and Drug Administration (FDA) inspections.
Areas Covered in the seminar:
- Key elements of the audit process.
- How to correct audit observations for incomplete reports.
- Examine the steps necessary to ensure completion of various types of investigations.
- Various tracking systems to ensure proper follow-up.
- Ensure that SOPs and work instructions are updated to reflect any changes.
- Obtain timely approval of the investigation report.
- Anticipating and avoiding common barriers and obstacles.
Who Will Benefit:
This webinar will provide direction to perform audits of the Process Deviation and/or Failure Investigation System.- Managers
- Supervisors
- Associates
- Quality Assurance
- Quality Control
- Compliance and Manufacturing
Course Provider
Michelle Sceppa,
