Auditing Quality Suppliers and Vendors
The various regulatory agencies have expectations that pharmaceutical manufacturers will demonstrate control over their manufacturing processes, validations, and documentation. Quality auditing is the process of checking whether these organizations have implemented what they have stated in written procedures and whether their people are doing what the organizations procedures state they will do.Learning ObjectivesUnderstand what a regulatory compliance audit isUnderstand the background and basics of regulatory compliance auditingUnderstand proper Auditor conductCommunicationDressPunctualityDifficult SituationsLearn the necessary skills for conducting auditsUnderstand how to prepare and plan for a regulatory compliance auditUnderstand and know how to properly perform an auditOpening meetingTouring the facilityQuestionsObservationsCloseout meetingUnderstand the types of regulatory compliance auditsLearn proper questioning techniquesUnderstand proper audit observation classificationLearn to write an audit reportUnderstand conducting a follow-up auditLearn how to become Lead Auditor certifiedASQ CertificationISO CertificationCourse Level - Basic/FundamentalAreas CoveredRegulatory Compliance AuditingTypes of Regulatory Compliance AuditsProper Auditor ConductSkills for Conducting Regulatory Compliance AuditsPreparing and Planning for a Regulatory Compliance AuditPerforming the AuditObservation ClassificationWriting an Audit ReportConducting a Follow-up AuditLead Auditor Certification ProgramsQuestionsWho Should AttendSenior quality managersQuality professionalsRegulatory professionalsCompliance professionalsProduction supervisorsValidation engineersManufacturing engineersProduction engineersDesign engineersProcess ownersQuality engineersQuality auditorsDocument control specialistsWhy Should You AttendThis 90-minute overview is designed for people tasked with performing internal and external audits for their organizations. It is also for those tasked with developing, maintaining and/or improving programs for manufacturing facilities. This includes individuals that have Quality Management Systems responsibilities for making general improvements in their organization’s performance specifically related to equipment, processes, and documentation.
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The various regulatory agencies have expectations that pharmaceutical manufacturers will demonstrate control over their manufacturing processes, validations, and documentation. Quality auditing is the process of checking whether these organizations have implemented what they have stated in written procedures and whether their people are doing what the organizations procedures state they will do.
Learning Objectives
- Understand what a regulatory compliance audit is
- Understand the background and basics of regulatory compliance auditing
- Understand proper Auditor conduct
- Communication
- Dress
- Punctuality
- Difficult Situations
- Learn the necessary skills for conducting audits
- Understand how to prepare and plan for a regulatory compliance audit
- Understand and know how to properly perform an audit
- Opening meeting
- Touring the facility
- Questions
- Observations
- Closeout meeting
- Understand the types of regulatory compliance audits
- Learn proper questioning techniques
- Understand proper audit observation classification
- Learn to write an audit report
- Understand conducting a follow-up audit
- Learn how to become Lead Auditor certified
- ASQ Certification
- ISO Certification
Course Level - Basic/Fundamental
Areas Covered
- Regulatory Compliance Auditing
- Types of Regulatory Compliance Audits
- Proper Auditor Conduct
- Skills for Conducting Regulatory Compliance Audits
- Preparing and Planning for a Regulatory Compliance Audit
- Performing the Audit
- Observation Classification
- Writing an Audit Report
- Conducting a Follow-up Audit
- Lead Auditor Certification Programs
- Questions
Who Should Attend
- Senior quality managers
- Quality professionals
- Regulatory professionals
- Compliance professionals
- Production supervisors
- Validation engineers
- Manufacturing engineers
- Production engineers
- Design engineers
- Process owners
- Quality engineers
- Quality auditors
- Document control specialists
Why Should You Attend
This 90-minute overview is designed for people tasked with performing internal and external audits for their organizations. It is also for those tasked with developing, maintaining and/or improving programs for manufacturing facilities. This includes individuals that have Quality Management Systems responsibilities for making general improvements in their organization’s performance specifically related to equipment, processes, and documentation.
