COURSE OUTLINE
Due to the complexity of today’s medical products, routine end-product testing alone is often not sufficient to assure product quality for several reasons. Some end-product tests have limited sensitivity. In some cases, destructive testing is required to show that the manufacturing process is adequate. In certain situations end-product testing does not reveal variations that may occur in the product which may impact safety and effectiveness. The FDA believes through careful design and validation of both the process and process controls, a manufacturer can establish a high degree of confidence that all manufactured units from successive lots will be acceptable. Successfully validating a process may reduce the dependence upon intensive in-process and finished product testing.
This 2 day special training program is intended as an introductory course to provide participants to have a basic understanding of process validation and its benefits, process validation from a regulatory perspective, phases of process validation, elements of process validation and their execution, to develop skills for preparation of protocol and report.
Who Should Attend
Managers, Executives, Supervisors of various departments: Quality Assurance, Production, Laboratory, Purchasing, Management Representatives, Inspectors, and Internal Auditors should attend this seminar.
Seminar Materials
Seminar manual with workshop and guide for conducting of process validation.
Seminar Goals
• Understanding process validation, its benefits, and phases of validation.
• Applying process validation in the applicable processes and process validation decision.
• Conducting process validation, preparation of validation protocol and validation report.
• Understanding revalidation, its relation to change control