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Validity : 20th Apr'24 to 30th Apr'24
Analytical Instrument and Equipment Qualification
- 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
Overview of the webinar
Analytical instruments should be qualified and systems should be validated to demonstrate suitability for the intended use. 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.
Who should attend?
- Laboratory managers, supervisors and analysts
- QA managers and personnel
- Quality control unit directors and staff
- IT managers and staff
- Consultants
- Laboratory suppliers of material, equipment and services
Why should you attend?
- 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
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.