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Understand FDA 21 CFR 210 and 211 Pharmaceutical CGMP and ISO 13485 definitions, concepts, and guidelines
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Know the requirements of the FDA 21 CFR 210 and 211 Pharmaceutical CGMP regulations and ISO 13485 quality management standard
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Understand the process approach
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Know the records required for internal and external audits
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Understand audit team leader responsibilities and how to communicate effectively during the audit
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Possess the skills to evaluate the competence and skills of auditors and select the audit team members
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Realize the roles and responsibilities of the auditor
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Be capable of conducting all phases of an audit using a risk-based approach and identifying nonconformances
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Understand the requirements for planning the audit and conducting the opening and closing meetings
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Know methods to prepare audit conclusions and the audit report