This package features 29 procedures and templates which provide a foundation for implementing a comprehensive Computer System Validation program within an organization.

This training package features an Adobe Flash training presentation with audio, which provides a strong tool for training a workforce in the fundamentals of current Good Documentation Practices.

This SOP package features a procedure that provides comprehensive instructions on creating Detailed Process Descriptions, which provide the most up-to-date information on equipment, materials, methods, process steps, and unit operations, as well as specifications for raw materials and components, intermediates, bulk drug substances, and drug product.

This Standard Operating Procedure (SOP) package features a 19 page document which outlines guidelines for transferrring technology for the development or manufacturing of biopharmaceuticals, vaccines, or combination devices.