2020 - Global Regulations for Equipment Qualification and Validation of Processes in the Pharma Manufacturing

Understand what the global expectations are for equipment qualification and validation.
Understand the documents required for equipment qualification and process validation and how to manage documents appropriately.
Understand and know how to write and maintain a Validation Master Plan.
Write and execute sound protocols for equipment qualification (IQ, OQ, PQ) and process validation.
Qualify already existing systems and requalification
Be able to collect data, conduct tests, and obtain all necessary documents.
Understand the different types of validation.
Understand Performance Validation.
Know the guidelines on validating analytical methods and processes.
Support equipment qualification and validation through the quality management system, risk analysis, calibration and maintenance, and change control.
Understand and know the principles of auditing the equipment qualification and validation.
Understand external qualification and validation from a contract manufacturer, and qualification and validation by a supplier.
To investigate true root causes of problems and to evaluate and prioritize solutions
Problem solving methods to help you asses which is best for your situation
Develop successful implementation plans
Perform risk assessments effectively