FDA Quality System Regulation - Guidelines on Validating Analytical Methods and Processes

On-Demand Schedule Fri, January 22, 2021 - Fri, January 29, 2021
Duration 90 Mins
Level Intermediate
Webinar ID IQW19J1077

  • Requirements and approaches for Analytical Instrument Qualification
  • Going through the qualification phases
  • Testing and deviation handling
  • Retrospective qualification and Requalification
  • Equipment Maintenance and Change control
  • Type and extend of qualification for USP Instrument Categories
  • Requirements and approaches for Laboratory Computer Systems
  • Validation of Laboratory Computer systems
  • Validation and Use of Excel in the QC Laboratory
  • Periodic review and revalidation of chromatographic data system
  • Handling raw data and other laboratory records
  • Ensuring Integrity and Security of Laboratory (Raw) data
  • Auditing Laboratory Computer Systems and records for FDA Compliance

Overview of the webinar

In this webinar you will learn the FDA’s 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. We will examine best practices to provide thoughts and ideas to develop or improve the performance of your current system.This webinar will help attendees understand the instrument qualification and system validation processes and will provide instruction on how to prepare for FDA audits and how to become part 11 compliant.

Who should attend?

  • 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

Why should you attend?

The objective of this course is to help attendees understand  that the cost of non-compliance is more than that of compliance. Are you in compliance with the FDA regulations for analytical equipment qualification and validation in your facility?

Faculty - Ms.Joy L. McElroy

Upon earning a degree in Zoology at North Carolina State University, Joy began working in the pharmaceutical and biotech industries in 1992 at Pharmacia & UpJohn performing Environmental Monitoring and Sterility Testing.  Her work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw the 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 19 years of experience as a consultant, and over 25 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Technical Writing, Process and Cleaning Validation, and Equipment Qualification and Computer System Validation and Part 11 Compliance. She has written and executed Equipment Qualifications and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Biotest, Novartis, Imprimis, Cody Laboratories, and Xceilence.

Her knowledge, experience, have made her a highly sought-after engineer, technical writer, and trainer in both the pharmaceutical and biotech industries.  Joy specializes in Equipment Qualification, Cleaning Validation, and GMP Compliance Auditing, and technical writing, and GMP, Audit Preparation, and SOP writing training, Computer System Validation and Part Compliance.

In 2019 she opened her own company, McElroy Training and Consultancy, LLC which provides consultants for various projects as well as on and off - site training to pharmaceutical and biotech companies throughout the United States.

 

Joy also spends her time mentoring and speaking as an Empowerment Speaker. Her goal is to empower people all over the world to live their dreams though implementing 5 simple techniques she has learned and applied through the years.

 

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