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 within 24 hours prior to the webinar.
  • Presentation handouts in pdf format will be emailed to along with the login instructions or few hours before the meeting starts.
  • Login to the session by clicking on “Join the Meeting” in the login instructions and then dial the number to connect to the meeting audio or use your Computer to connect to audio. Please use the name and the email address you used at the time of registration to join the meeting.
  • Get answer to your queries through interactive Q&A sessions. The Q and A sessions are at the end of the meeting. The expert will complete his/ her presentation and then the phone lines will be open for the audience to discuss your questions.
  • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve our Training programs.
  • Certificate of attendance is emailed to you within 6 working days from the date the webinar was completed. If you don’t receive an email within 6 days. Please email our support@grcts.com

Recorded Session - How it works

  • Login Information with Password to view the webinar will be emailed to you within 48 hours from the date the Live webinar was completed. The link to the recording is for a single person use only and it is valid for 6 months or the actual duration the recording was purchased.
  • Please click on the link to access the Recording and type in the password provided in the email.
  • Presentation and other handouts will be emailed to you in a pdf format.

Training CD - How it works

  • Free shipment within 2 working days, from the date the webinar was completed. The presentation and other handouts will be emailed to you in a pdf format if we are unable to attach them in the CD or USB.

(For more information 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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