Analytical Instrument Qualification & Validation – Use of Excel and FDA Audit Preparation
Time (Eastern Time US): 10 AM to 3 PM
Time (Central Europe): 4 PM to 9 PM
Duration: 2 DAYS
Course Director: JOY MCELROY
As Various parts of the world are still battling the Coronavirus (COVID-19), we are conducting the class 100% online.
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COURSE DIRECTOR
Joy McElroy
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 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.
Seminar Description
ABOUT THE COURSE
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. 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 seminar 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.
SEMINAR 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 and execute test protocols, this includes setting specifications and acceptance criteria
- Understand how to review and approve qualification and validation protocols
- Understand Validation and Use of Excel in the QC Laboratory
- Learn about Handling raw data and other laboratory records
- Be able to develop inspection ready qualification and validation deliverables
- Learn how to avoid and/or respond to FDA inspectional observations and warning letters
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
Agenda
Lecture 1 :
- Requirements and approaches for Analytical Instrument Qualification
- Going through the qualification phases
Lecture 2 :
- Testing and deviation handling
- Retrospective qualification and Requalification
Lecture 3 :
- Equipment Maintenance and Change control
- Type and extend of qualification for USP Instrument Categories
Lecture 4 :
- Requirements and approaches for Laboratory Computer Systems
- Examples for risk assessment of computer systems
Lecture 5 :
- Validation of Laboratory Computer systems
- Preparing inspection ready validation documentation
Lecture 6 :
- Validation and Use of Excel in the QC Laboratory
- How to ensure spreadsheet and data integrity
Lecture 7 :
- Periodic review and revalidation of chromatographic data system
- Handling raw data and other laboratory records
- Ensuring Integrity and Security of Laboratory (Raw) data
Lecture 8 :
- Auditing Laboratory Computer Systems and records for FDA Compliance
- Learn how to avoid or respond to FDA 483s and warning letters
Registration Options
2-Day Seminar on Analytical Instrument Qualification and Validation – Understanding Use of Excel and FDA Audit Preparation
- Date: 7/7/2022 10:00 AM
- Location Online Event
