Pittcon 2015

Siri H. Segalstad has submitted four classes for Pittcon 2015, which will take place in New Orleans, mid March 2015:

ISO 17025 – 2-day class

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

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. One part of validation is the supplier audit. This should preferably be done before the system is bought, but in practice it is often not done until the system is in place, unfortunately. 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?

IT Supplier audits -1 day class

The IT supplier needs to be audited when you work in the regulated industries (pharma, environmental, health, accredited lab, etc.). This class will teach how to plan and carry out an audit, and how to write the audit report. The teacher has passed her TickIT auditor’s exam for ISO 90003.

LIMS – Laboratory Information Management Systems -1 day class

LIMS is the heart of the laboratory. Here is where all the information is stored. The class will teach you how to write the User Requirements Specification and  how to implement the chosen LIMS in a good way.