Are You Ready For An FDA Manufacturing Site Inspection?

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Successfully managing an FDA inspection begins with the development of a clear company policy. It requires frequent employee training so they are in a position to maintain best practices regarding day-to-day procedures. Companies also need to make sure they define the roles and responsibilities of all company employees during an inspection.

If conducted properly, a quality audit can detect program defects and, through isolation of unsatisfactory trends and correction of factors that cause defective products, prevent the production of unsafe or nonconforming devices. Without an effective quality audit function, the quality system is incomplete and there is no assurance the manufacturer is consistently in a state-of-control.

Inefficient manual audit procedures negatively impact operational effectiveness and can increase the risk of low product quality as a result of:

  • Poor communication and scheduling
  • Inconsistent audit output
  • Lack of visibility and insight into issue trending
  • Difficulty in ensuring resolution of corrective and preventive actions (CAPA)

During this webinar, you will learn practical techniques for improving audit preparation, execution and post audit activities for both internal and supplier audits.  You will also gain insights on how leading companies are leveraging technology to enable end-to-end audit process automation to improve compliance, and as a result are reducing audit costs, increasing productivity, reducing operational risks and ultimately improving product quality.


Who Should Attend

Individuals involved in:

  • Executive Management
  • Quality, Compliance, and IT Managers
  • Manufacturing Directors and Supervisors
  • Pharmaceutical and cGMP Auditors
  • QA/QC personnel
  • R&D Staff
  • Regulatory Affairs Professionals
  • Risk Management Specialists
  • Training Personnel
  • Validation Specialists, Scientists, Engineers