Why Should You Attend: 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.
Learning Objectives: - 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 terminology.
- Validation master planning.
- Design qualification.
- Installation qualification.
- Operation qualification.
- Performance qualification.
- Process validation.
- Equipment cleaning validation.
- Analytical methods validation.
