ComplianceOnline

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

Instructor: Joy McElroy
Product ID: 704306
  • Duration: 90 Min

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$299.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This 90-minute training program 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 system responsibilities for making general improvements in their organization’s performance specifically related to equipment, processes and documentation.

Why Should You Attend:

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.

Upon completing this course participants should:

  • Understand what a supplier and vendor audit is
  • Understand the background and basics of supplier and vendor 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 supplier and vendor audit
  • Understand and know how to properly perform an audit
    • Opening meeting
    • Touring the facility
    • Questions
    • Observations
    • Close out meeting
  • 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

Areas Covered in the Webinar:

  • 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

Who Will Benefit:

  • 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

Instructor Profile:

Upon earning a degree in Zoology at North Carolina State University, Joy McElroy made her debut in the pharmaceutical industry in 1992 at Pharmacia & UpJohn performing environmental monitoring and sterility testing. Her hard work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw their quality control lab. In 1998, Ms. McElroy moved to Wyeth Lederle and worked in quality assurance, performing GMP compliance audits, batch record reviews, and holding annual GMP training for new employees. After working in quality assurance for a few years, she moved into equipment qualification and cleaning validation at Mallinckrodt.

With over 20 years total experience in the pharmaceutical and biotech industries, Ms. McElroy has gained extensive knowledge of quality assurance, process and cleaning validation, equipment qualification, sterilization, and GMP compliance auditing. Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries.

In 2013, Ms. McElroy started her 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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