Classes

Are you looking for a specialized course?

Your company may have specific requirements, your own project or your own internal procedures which need to be included in the class to make it more useful for you. Segalstad Consulting can tailor a class to your needs and incorporate your requirements. We can plan the class together, and make it just the way you need it. Below are some examples of classes that have been given, but any class can be discussed. We have contacts that may add their specialties if we do not have the knowledge ourselves.
The classes are of course tailored to the target audience. They may be given as presentations or as workshops.

Examples of classes I’ve either taught for companies or offered as open classes at various conferences:

• Validation of computer systems in general. Including requirements for the external standards that the company uses (GMP / GLP / GCP / 21 CFR 11 / GAMP / ISO 17025, etc.). Including requirements from their internal standards (policies / quality manual / SOPs, etc.)
• Validation of the company’s chosen system, for example LIMS. Including requirements for the external standards that the company uses (GMP / GLP / GCP / 21 CFR 11 / GAMP / ISO 17025, etc.). Including requirements from their internal standards (policies / quality manual / SOPs, etc.). Including their implementation / validation plan etc.
• 21 CFR Part 11. Understanding 21 CFR Part 11 requirements: Technical requirements, Validation requirements, Procedural requirements, Practical implementation.
• 21 CFR 11 Project: Creating checklists for compliance, Assessing systems for compliance.
• LIMS: Understanding LIMS, LIMS Project and system validation.
• Classes for suppliers and other programmers.
• Build in quality according to 21 CFR Part 11 and ISO 90003.
• Supplier audits: Requirements in ISO 90003 / GAMP, Planning and performing the audit, Receiving the audit.
• How to create a Quality Management System: Including IT systems in the Quality Management System (QMS).