Risk Based Approach to Auditing Quality Suppliers and Vendors


Friday, March 15, 2019   |   10:00 AM PDT | 01:00 PM EDT   |   Duration: 90 Minutes          

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Duration: 90 Minutes  

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Price: US$390.00

This webinar 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.

Joy McElroy   Product Id : 502413
  Instructor : Joy McElroy

  More Trainings by this Expert


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 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. The following personnel will benefit from the course.

Areas Covered in the Session:

  • Regulatory Compliance Auditing
  • Types of Regulatory Compliance Audits
  • Proper Auditor Conduct
  • Performing the Audit
  • Observation Classification
  • Writing an Audit Report
  • Conducting a Follow-up Audit
  • Lead Auditor Certification Programs
  • Learn proper questioning techniques
  • Learn to write an audit report
  • Understand proper Auditor conduct
  • Understand what a regulatory compliance audit is
  • Skills for Conducting Regulatory Compliance Audits
  • Learn the necessary skills for conducting audits
  • Preparing and Planning for a Regulatory Compliance Audit
  • Understand the background and basics of regulatory compliance auditing
  • Understand how to prepare and plan for a regulatory compliance audit
  • Understand and know how to properly perform an audit

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


Speaker Profile
Joy McElroy Upon earning a degree in Zoology at North Carolina State University, She 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 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.

Upon earning a degree in Zoology at North Carolina State University, She 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 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.




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