Analytical Instrument Qualification and Excel Validation - Preparing for FDA Audits
Description:
This comprehensive two-day workshop will help you master the expectations of global regulatory agencies regarding analytical equipment qualification and the development of robust process validation programs. This seminar will equip you with the knowledge to create and implement foolproof solutions that are efficient, effective, and meet regulatory standards. Through detailed case study analysis, we will explore best practices and provide insights to enhance or refine your current systems.
Learn how your management practices for analytical equipment qualification, validation, and process validation programs can significantly impact your legal liability and compliance status. We will address the legal ramifications of nonconformance with regulatory requirements and the potential costs associated with non-compliance, which often exceed those of compliance. Ensure your facility meets FDA regulations for analytical equipment qualification and validation.
This seminar is designed to help attendees grasp the complexities of instrument qualification and system validation processes. It will offer practical guidance on preparing for FDA audits and achieving Part 11 compliance.
SEMINAR AGENDA:
| DAY 1 (9 AM to 2 PM) | DAY 2 (9 AM to 2 PM) | |
Lecture 1:
| Lecture 5:
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Seminar Objectives:
- 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.
Who Should Attend:
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
