Auditing and Qualifying Suppliers and Vendors - An Effective Risk Based Approach

Schedule Tuesday, June 25, 2019 || 10:00 AM PDT | 01:00 PM EDT
Duration 90 Mins
Level Basic & Intermediate & Advanced
Webinar ID IQW19F0621

Upon completing this course participants will understand:

  • What a supplier and vendor audit is
  • Background and basics of supplier and vendor auditing
  • Proper Auditor conduct:

    1. Communication     
    2. Dress
    3. Punctuality
    4. Difficult situations
  • Necessary skills for conducting audits
  • How to prepare and plan for a supplier and vendor audit
  • Know how to properly perform an audit:

        1. Opening meeting
        2. Touring the facility
        3. Questions
        4. Observations
        5. Close out meeting

  • Proper questioning techniques
  • Proper audit observation classification
  • Write an audit report
  • Conducting a follow up audit
  • How to become Lead Auditor certified:

        1. ASQ Certification
        2. ISO Certification

Overview of the webinar

The various regulatory agencies have expectations that suppliers and vendors 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.

Who should attend?

This 90 minute overview is designed for people tasked with performing 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

Why should you attend?

Attend this webinar to learn in depth about:

  • Supplier and Vendor Auditing
  • Types of Supplier and Vendor Audits
  • Proper Auditor Conduct
  • Skills for Conducting Regulatory Compliance Audits
  • Preparing and Planning for a Supplier and Vendor Audit
  • Performing the Audit
  • Observation Classification
  • Writing an Audit Report
  • Conducting a Follow-up Audit
  • Lead Auditor Certification Programs
  • Questions

Faculty - Ms. Joy L. McElroy

Upon earning a degree in Zoology at North Carolina State University, I began working in the pharmaceutical industry in 1992 at Pharmacia & Upjohn performing Environmental Monitoring and Sterility Testing.  My work allowed me to move into a supervisory role at Abbott Laboratories where I oversaw the Quality Control Lab. In 1998 I moved to Wyeth Lederle and worked in Quality Assurance, performing GMP Compliance audits, batch record reviews, holding annual GMP training for new employees, and writing audit report, and SOPs. After working in Quality Assurance for a few years, I moved into Equipment Qualification and Cleaning Validation at Mallinckrodt.

With 12 years of experience as a consultant, and over 20 years total experience in the pharmaceutical and biotech industries, I have gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification, and Technical writing. I have written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Phillips Medisize. I also develop and deliver webinars, on-site training, and seminars for training in areas such as Technical Writing, Equipment Qualification, Cleaning Validations, FDA Audit Preparation and more.

In 2013 I started my own company, Maynard Consulting Company, which provides top engineers, auditors, and validation specialist to pharmaceutical, biotech and medical device clients across the United States, Canada, and the world. 

 

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