Auditing Quality Suppliers and Vendors
Duration : 90 Minutes
Joy L. McElroy,
Joy McElroy entered the pharmaceutical industry in 1992 shortly after earning a Bachelor of Science degree at North Carolina State University. She began at Pharmacia & UpJohn performing environmental monitoring and sterility testing. From there she moved into a supervisory role at Abbott Labor Read more
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.
Course Objective:
• Understand what a regulatory compliance audit is.
• Understand the background and basics of regulatory compliance auditing.
• Understand proper Auditor conduct.
o Communication
o Dress
o Punctuality
o 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.
o Opening meeting
o Touring the facility
o Questions
o Observations
o 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
o ASQ Certification
o ISO Certification
Course Outline:
• 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
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
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. The following personnel will benefit from the course:
• 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
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
