Updated October 29, 2022
The "Auditing" course is no longer available.
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Purpose:
This class teaches students how to:
- apply an auditing model that applies to a wide-variety of situations
- qualify suppliers, to assure that they meet your specifications and appropriate GMPs
Upon class completion, students will be able to:
- State the regulatory requirements for audits.
- Identify common reactions to the audit process.
- Manage adverse reactions to audits.
- Plan an efficient and thorough audit.
- Apply the Quality System inspection approach for audit planning.
- Review relevant regulations applicable to the audit area.
- Gather evidence of compliance/noncompliance.
- Report results to affect change and build relationships.
- Manage the corrective action and preventive action process
Topics covered in class include:
- Managing audits
- Pre-audit questionnaire
- Audit focus
- Gathering evidence
- Ratings
- Auditing report
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