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

COURSE AGENDA

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

Contractor and supplier audits

  • When to audit – initial evaluation versus re-certification
  • 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

Audit System

  • Define responsibilities
  • Ensure auditor qualifications and training (Section 820)
  • Developing an audit schedule – Risk Based
  • Preparation for the audit (developing audit conduct tools):
    • Audit Plans
    • Audit Checklists
    • Review of past history and additional background data
  • Auditor Best Practices:
    • 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

Audit Follow-Up and Closure

  • Follow-up and final documentation
  • Audit Closure
  • Audit Reports
  • Relation to CAPA

Second Day

Conducting Audits

  • Review key areas for each type of audit focus.  Will include what to look for and questions to ask when conducting the following types of audits
  • Good Clinical Practice Audits
    • Planning
    • Scheduling
    • Audit Conduct – key areas of focus
    • Reporting of audit results
  • Good Laboratory Practice Audits
    • Planning
    • Scheduling
    • Audit Conduct – key areas of focus
    • Reporting of audit results
  • Good Manufacturing Practices/Quality System Audits
    • Planning
    • Scheduling
    • Audit Conduct – key areas of focus
    • Reporting of audit results

 

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