San Francisco, California
London, United Kingdom
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
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
Note: Use coupon code NB5SQH8N and get 10% off on registration.
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When & Where
Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.