Analytical Instrument Qualification & Validation – Use of Excel and FDA Audit Preparation

• 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

This seminar will be beneficial personnel in pharmaceutical development and quality control laboratories and contract testing laboratories as well as Individuals that have Quality Management Systems responsibilities for making general improvements in their organization’s performance specifically related to equipment and processes. Following personnel will benefit from the course:

• 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

DAY 1 (10 AM to 3 PM)

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

DAY 2 (10 AM to 3 PM)

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

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.