FDA Regulations for Analytical Instrument Qualification and Validation Processes

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

"Ms. Joy L. McElroy 12 years of experience as a consultant, and over 20 years total experience in the pharmaceutical and biotech industries""

Global agencies expectations of analytical equipment qualification along with the development

Description

In this webinar you will learn the different global agencies expectations of analytical equipment qualification along with the development of a sound process validation program in order to develop and implement bulletproof solutions that are accepted, effective, and efficient. Through case study analysis we will examine best practices to provide thoughts and ideas to develop or improve the performance of your current system.

Additionally, case studies will explore how your management practices of your analytical equipment qualification/ validation and process validation programs can help or hurt your legal liability and the legal issues that arise from nonconformance with regulators and Auditors.

Objectives

 

  • Learn about the regulatory background and requirements for laboratory instrument qualification and system validation
  • Understand the logic and principles of instrument qualification and system validation from validation planning reporting
  • Understand and be able to explain your company's qualification and validation strategies
  • Be able to independently prepare execute test protocols, this includes setting specifications and acceptance criteria
  • Understand how to review and approve qualification and validation protocols
  • Be able to develop inspection ready qualification and validation deliverables
  • Learn how to avoid and/or respond to FDA inspectional observations and warning letters

Why Should you Attend

The cost of non-compliance is therefore more than that of compliance. Are you in compliance with the FDA regulations for analytical equipment qualification and validation in your facility? This 90 minute webinar will provide attendees the regulatory background and guidance through the complete process from planning and writing requirement specifications to vendor assessment, installation and operational qualification and ongoing testing during routine use. This webinar will help attendees understand the instrument qualification and system validation processes.

Areas Covered

  • Requirements and approaches for Analytical Instrument Qualification
  • Risk based validation approach
  • Going through the qualification phases
  • User requirements, writing the specifications
  • Testing and deviation handling
  • Proper documentation
  • Type and extend of qualification for USP Instrument Categories
  • Periodic review and revalidation analytical instruments and equipment
  • Wrap up - Final questions and answers

Who will Benefit

  • Laboratory managers, supervisors and analysts
  • IT managers and staff
  • Consultants
  • Laboratory suppliers of material, equipment and services
  • 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

Industries who can attend

This 90-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel


Speaker Profile

Joy McElroy

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 Ma

Back to Top