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Regulatory authorities are increasingly expecting on-going, competent assessments of internally and externally sourced processes and materials. This course provides foundational information on regulatory requirements and expectations for audits as well as the different types of audits and their purposes. Additional information includes how to plan, conduct, and report audits as well as the investigatory and assessment tools used in audits.
This 1 day 8 hour course covers the following topics:
- Three audit classification: Qualification, Surveillance and Special (For-Cause) Audits
- Regulatory Requirements and Expectations
- Food, Drug and Cosmetics Act
- 21 CFR Regulations
- Auditor Skills and Competencies
- Auditor Code of Conduct
- Audit Process Planning through Finalization
- Auditing Tools and Statistical Aids
- Audit Execution and Elements of Final Report
Upon successful completion participants will be able to:
- Provide an overview of general audit elements and principles
- Understand the basic process for planning, executing and closing an audit
- Define auditor skills and competencies
- Identify regulatory requirements and expectations applicable to audits
Course material is appropriate for personnel new to auditing, experienced auditors that are assuming lead auditor responsibility, and senior management responsible for resourcing audit efforts and assessing the information obtained from those audits.