Learning Objectives:Sign up your entire team and get a clear understanding of the requirements and methods for process validation, including:Understanding what “a high degree of assurance” means in statistical terms.The three step approach employing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).Developing protocols and reports for IQ, OQ, and PQ.What information to include in the protocols and reports.How to use the link the IQ Protocol to OSHA requirements to enhance your total regulatory compliance.The basics of Statistical Process Control (SPC) to help monitor the validated process.The role of Design of Experiments (DOE) to help define acceptable process parameters and develop challenge points.Using attribute sampling plans in process verification.The FDA Guidance document on process validation and the current status from the CDRH view.The Global Harmonization Task Force (GHTF) document on process validation.