Pittcon 2010

Siri H. Segalstad will teach four classes at Pittcon 2010, which will take place in Orlando, Florida in late February and early March:

ISO 17025

Date: February 28, 2010

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.

Practical Validation of IT Systems in the Regulated industries

Date: March 2, 2010

Abstract:
Regulated industries like healthcare, pharmaceutical, food, environmental, as well as quality-certified / accredited industries all have requirements for process control. IT systems make up integral parts of the processes, and will thus need to be validated and under control throughout their life cycle. This class provides a thorough and practical class on how to work in order to create and maintain a validated 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?

Laboratory Information Management Systems (LIMS)

Date: March 3, 2010

Abstract:
LIMS systems are used extensively in laboratories everywhere. The systems are now mature and well-functioning and there are many suppliers on the market. How do you select and implement a new LIMS?
• What to include in the User Requirements Specification.
• How do you select your supplier?
• There are many ways to implement LIMS. How do you implement a LIMS to make it work for your lab?

Audits of IT Suppliers

Date: March 5, 2010

Abstract:
As IT systems used in the regulated industries generally have been programmed by a supplier long before the system is acquired, it is crucial to check the built-in quality of the system. This is done in a supplier audit, but how is that done? The class will cover practical aspects of the audit and includes many examples from real audits:
• Which suppliers do we audit?
• Who shall do the audit?
• Which tools exist when our usual regulations do not cover any details?
• How do we prepare for the audit?
• How is the audit done?
• Audit report.
• Follow-up after the audit.
• Consequences of the audit result.

For more information about Pittcon’s short courses, visit the official short course page.

Pittcon 2010 LIMS