Analytical Instrument Qualification and Excel Validation - Preparing for FDA Audits

• Understand the regulatory background and requirements for laboratory instrument qualification and system validation.
• Learn the logic and principles of instrument qualification and system validation, from validation planning to reporting.
• Be able to explain and implement your company’s qualification and validation strategies effectively.
• Gain the skills to independently prepare and execute test protocols, including setting specifications and acceptance criteria.
• Learn how to review and approve qualification and validation protocols with confidence.
• Master the use of Excel in the QC Laboratory for validation purposes.
• Handle raw data and other laboratory records efficiently and compliantly.
• Develop inspection-ready qualification and validation deliverables.
• Learn strategies to avoid and respond to FDA inspectional observations and warning letters.

By the end of this workshop, you will be equipped with the knowledge and skills to enhance your compliance with FDA regulations, improve your process validation programs, and ensure your analytical instruments are qualified and validated effectively. Join us to stay ahead in the competitive landscape of laboratory compliance and audit preparedness.

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 (9 AM to 2 PM)

Lecture 1:

• Requirements and approaches for Analytical Instrument Qualification
• Going through the qualification phases
• ISO/IEC 17025 (Testing and Calibration Laboratories)

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
• 21 CFR Part 211.67 (Equipment Cleaning and Maintenance), USP <1058> (Analytical Instrument Qualification)

Lecture 4:

• Requirements and approaches for Laboratory Computer Systems
• Examples for risk assessment of computer systems

DAY 2 (9 AM to 2 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

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.