FDA Validation Requirements - Webinar By ComplianceOnline (FDA Validation Train)
Venue: Online Event
|Event Date/Time: Sep 16, 2011||End Date/Time: Sep 16, 2011|
Validation is the cornerstone of control over the manufacture and processing of many FDA-regulated products and is a CGMP requirement for drugs, biologics, and medical devices.
This course is intended to introduce the participants to validation terminology, structure of a validation program, and the basic contents of design qualification, installation qualification, operation qualification, performance qualification, process validation, analytical methods validation, equipment cleaning validation, and the validation of automated systems.
Understanding of validation terminology.
Understanding of structure for a validation program and validation master plan.
Understanding of elements of DQ, IQ, OQ, PQ, PV, and the validation of analytical methods, equipment cleaning methods, and automated systems.
Understanding of CGMP requirements.
Areas Covered in the Seminar:
Validation master planning.