is being presented by Dan O'Leary, President, of Ombu Enterprises and airs on Tuesday, October 5th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Process validation is an important element in medical device manufacturing, and this audio conference looks at the underlying statistical concepts to perform an effective process validation, examining elements of the FDA regulations for process validation (21 CFR §820.75) as well as the corresponding requirements in ISO 13485.
When you cannot (or do not) fully verify process results by subsequent inspection and test this leads to sampling plans, and in this presentation our speaker discusses the use of attribute sampling plans in this context. When you validate the process with a high degree of assurance, this means your process achieves a certain process capability. The presentation looks at the concepts of process capability, especially the use of common processes capability indices, Cp and Cpk.
Process validation often employs three phases, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). One role of OQ explores the parameter space that defines the process and selects challenge points as part of the qualification protocol. This naturally leads to Designed Experiments as the exploratory tool. Designed experiments determine the limits of the parameter space for the process. The same techniques, especially full and fractional factorial experiments, can establish “worst case” conditions that become challenge points for the OQ phase of process validation.
Lastly, Risk Management (ISO 14971) includes production information. This leads directly to validated processes since these are often the production processes that carry the greatest risk.
