Effective Internal and External Quality Assurance Auditing for FDA Regulated Industries™


First Day

Overview and general considerations:

  • Scope and purpose of the internal and external Quality Audit System
  • Regulatory background – requirements for each type of operation
  • Understanding the politics of auditing
  • Auditing / Regulatory Inspections –  the tie-in

Audit System

  • Define responsibilities
  • Ensure auditor qualifications and training
  • Schedule – Risk Based
  • Preparation for the audit
    • Plan
    • Checklist
    • Review past history and additional background data
  • Performance:
    • Key questions
    • Techniques
    • The importance of documentation
    • Listening & observation skills
    • What to do and what not to do
  • Conclusion-Audit reports
    • Categories of observations
  • Effecting change
  • Strategies and techniques to maximize audit effectiveness

Audit Follow-Up and Closure

  • Strategies and formats
  • How to evaluate proposed action plan by area being audited
  • Follow-Up and final documentation (Audit Closure)
  • Relation to CAPA

Second Day

Specific key areas of focus during audits

  • Good Manufacturing Practices/Quality System audits
  • Good Laboratory Practice audits
  • Clinical Study audits
  • Due diligence audits

Contractor and supplier audits

  • When to audit – initial evaluation versus on-going controls
  • Steps for conducting supplier audits
  • Problem resolution audits

What makes a good audit?

  • Audit objectivity
  • Auditing standards
  • Creating a win-win audit-turning the audit into a positive coaching experience for yourself, your company, and those you are auditing

Selling quality assurance audits to management

  • Learn why top management should care about audit findings
  • Discover how to get management to listen, buy-in, and take action on your audit findings


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