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


Joy L. McElroy is Keynote speaker at ComplianceKey. Upon earning a degree in Zoology at North Carolina State University, Joy made her debut in the pharmaceutical industry in 1992 at Pharmacia & UpJohn performing Environmental Monitoring and Sterility Testing. She then moved into a supervisory role at Abbott Laboratories where she oversaw their Quality Control Lab. From there she moved into auditing clinical and GMP laboratories, and manufacturing facilities, then into validation engineering. Now with 14 years experience as a consultant, and over 20 years total experience in the pharmaceutical ........

Overview

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.

Why should you attend this webinar?

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.

Areas Covered in the Session:

Learning Objectives:
  • Understand what a regulatory compliance audit is.
  • Understand the background and basics of regulatory compliance auditing.
  • Understand proper Auditor conduct.
  • 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.
  • 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

Who can Benefit:



Webinar Id: LSHCJM0019

Training Options:

Duration: 90 mins

 02/06/2019

 10:00 AM PT | 01:00 PM ET

 Single Attendee: [Only for one participant]

$179 (Live)                    $319 (Live + Recorded)

 Multiple Attendee: [For a group of 2-5 participants]

$368 (Live)                    $495 (Live + Recorded)

 Corporate Attendee: [For a group of 6-10 Participants]

$741 (Live)                    $1157 (Live + Recorded)

 Recorded: [Six month unlimited access]

$167 (Single Attendee) $599 (Unlimited Attendee)

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