Analytical instruments should be qualified and systems should be validated to demonstrate suitability for the intended use. This two day in-person seminar 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 interactive workshop will help attendees understand the instrument qualification and system validation processes and will provide templates and examples to develop inspection ready documentation.
Practical examples and interactive exercises will be dispersed into and between the presentations while 50% of the total time will be dedicated to practical sessions. During the seminar, attendees will work in small groups on case studies and prepare the answers using prepared fill-in templates. After the course a large variety of tools such as SOPs, validation examples and checklists will be readily available on a dedicated website that can be used to easily implement what they have learned from the course.
- 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 to 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
- Learn how to avoid and/or respond to FDA inspectional observations and warning letters
1. 70-page primer – Analytical Instrument Qualification and System Validation (authored by Dr. Ludwig Huber)
3. Full Set of Qualification examples for an HPLC system
4. Full set of Validation examples of a chromatographic Data System
5. Qualification conditions, frequency of requalification and acceptance limits for 20 laboratory instruments
Who Should Attend
This seminar will be beneficial for the following personnel in pharmaceutical development and quality control laboratories and contract testing laboratories.
- Laboratory managers, supervisors and analysts
- QA managers and personnel
- Quality control unit directors and staff
- IT managers and staff
- Laboratory suppliers of material, equipment and services