Auditing Quality Suppliers and Vendors

  • Speaker:Joy McElroy
  • Duration:90Min
  • Product Code:GRC-90298

$269

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Live Session - How it works

  • Username and Password will be sent to you 24 hours prior to the webinar.
  • Presentation handouts in pdf format will be mailed to you.
  • Login to the session using the username and password provided to you.
  • Get answer to your queries through interactive Q&A sessions via chat.
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  • Get certification of attendance.

Recorded Session - How it works

  • Login Information with Password to view the webinar, 24 hours after the Live webinar (link valid for 6 months).
  • A link will be provided to you upon purchase of the recorded session.
  • Please click on the link to access the session.
  • Presentation handouts in pdf format will be mailed to you.
  • Get certification of attendance.

Training CD - How it works

  • Free shipment within 72 Hours, from the date of webinar completion.

(More about our products contact +1- 248-233-2049)

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com. 

Description:

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.

Why you must attend:
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:
  • 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 
Learning objectives:
  • Understand what a regulatory compliance audit is.
  • Understand the background and basics of regulatory compliance 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 regulatory compliance audit.
  • Understand and know how to properly perform an audit.
  • Opening meeting
  • Touring the facility
  • Questions
  • Observations
  • 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
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 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 Joy 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, Joy moved into Equipment Qualification and Cleaning Validation at Mallinckrodt. With 10 years of experience as a consultant, and over 20 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification.

She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Phillips Medisize. Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries.  Joy specializes in Equipment Qualification, Sterilization, Cleaning Validation, and GMP Compliance Auditing. 

In 2013 Joy 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.

Available Options

Recording: Access the training Recording for 6 months from any location

$269

CD: Shipped within 2 working days

$389

USB - Shipped within 2 working days

$409

5 Member Group: 5 can Attend Live Meeting Online from any location globally

$2,249

10 Member group: 10 can Attend Live Meeting Online from any location globally

$3,569

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