This course is specifically designed to meet the analytical needs of those individuals working within FDA regulated industries. A key component of pharmaceutical, medical device and biotechnology product development is to perform process validation and qualification studies. The basic concepts, requirements and statistical methods for process validation are presented.
This course is required for all employees who actively work on process sciences, process development and process validation.
ESDA and DOE are recommended prior to this course.
Process Validation and Drug Quality
General Approach to Process Validation
Statutory and Regulatory Requirements for Process Validation
Process Validation Recommendations
Building and Capturing Process Knowledge and Understanding
Establishing a Strategy for Process Control
Design of a Facility and Qualification of Utilities and Equipment
Process Performance Qualification
PAT during Qualification
PPQ Protocol Execution and Report
Establishing a Monitoring Program
Data Analysis Trending and ongoing Capability Monitoring
Deviations/Investigations and CAPA
CPV Data Review and Reporting
DOE design space
DOE, CPP and PAR analysis
POV and Sample Size during PV
Process Capability and Design Margin
Control Charts during Validation
ANOVA and ANOM