Auditing Quality Suppliers and Vendors
- Speaker:Joy McElroy
- Product Code:GRC-90298
Live Session - How it works
- Username and Password will be sent to you within 24 hours prior to the webinar.
- Presentation handouts in pdf format will be emailed to along with the login instructions or few hours before the meeting starts.
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Recorded Session - How it works
- Login Information with Password to view the webinar will be emailed to you within 48 hours from the date the Live webinar was completed. The link to the recording is for a single person use only and it is valid for 6 months or the actual duration the recording was purchased.
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Training CD - How it works
- Free shipment within 2 working days, from the date the webinar was completed. The presentation and other handouts will be emailed to you in a pdf format if we are unable to attach them in the CD or USB.
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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 organization's procedures state they will do.
- 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
- Interact with the instructor - Q and A
- Understand what a regulatory compliance audit is.
- Understand the background and basics of regulatory compliance auditing.
- Understand proper Auditor conduct.
- 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
- Close out 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
- 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