Pittcon 2012
Siri H. Segalstad will teach two classes at Pittcon 2012, which will take place in Orlando, Florida mid March 2012:
ISO 17025 – 2-day class
Dates: To be determined
Abstract:
Labs that aim for accreditation through the Lab Accreditation standard ISO 17025 will benefit from this class, as I’ll focus on explaining the standard from A to Z. The result is a practical class with many examples of how to understand and solve the requirements in the standard:
• Requirements in the standard.
• How to create the quality system.
• How to handle traceability and confidentiality.
• What to do with the IT systems?
• How to handle contracts.
• How to cooperate with the customers.
Labs that aim for accreditation through the Lab Accreditation standard ISO 17025 will benefit from this class, as I’ll focus on explaining the standard from A to Z. The result is a practical class with many examples of how to understand and solve the requirements in the standard:
• Requirements in the standard.
• How to create the quality system.
• How to handle traceability and confidentiality.
• What to do with the IT systems?
• How to handle contracts.
• How to cooperate with the customers.
For more information about Pittcon’s short courses, visit the official short course page.
Practical Validation of IT systems in the regulated industries
-1 day
Date: To be determined
Abstract:
Regulated industries like healthcare, pharmaceutical, food, environmental, as well as quality-certified / accredited industries all have requirements for process control. IT systems are integral parts of the processes, and will also need to be validated and under control throughout their whole life. This class will give a thorough and practical class on how to work in order to create a validated status and maintain the status for IT systems. The principle for all types of regulatory IT systems is covered. Practical examples include IT systems for production, laboratories, and patient records, to mention a few. Key words:
- Acquisition period: What do we do before we purchase the system?
- Installation period: How do we ascertain that the system is installed correctly?
- Testing period: How do we verify that the system works as intended?
- Maintenance period: How do we make sure that they system is maintained as validated?
- Acquisition period: What do we do before we purchase the system?
- Installation period: How do we ascertain that the system is installed correctly?
- Testing period: How do we verify that the system works as intended?
- Maintenance period: How do we make sure that they system is maintained as validated?

