The FDA’s Quality System Regulation (QSR) is clear on the importance of equipment controls – you must have and follow procedures for installing, operating and maintaining all equipment used in your manufacturing processes. And that includes any ancillary equipment that affects production, such as environmental systems and contamination controls.
This training program will list the documents required for equipment qualification and process validation and discuss how to manage documents appropriately. Attendees will gain insight into best practices for writing and maintaining a Validation Master Plan (VMP). The course will also discuss best practices for writing and executing sound protocols for equipment qualification (IQ, OQ, PQ) and process validation.
Who Should Attend:
Important: Please plan to bring a multidisciplinary group from your Company to gain the most from this very important seminar.
Quality Departments
Regulatory Affairs Departments
Compliance Departments
Engineering Departments
Manufacturing Departments
Production Departments
Operations Departments
Validation Teams
Design Engineers
Process Owners
Internal Auditors
Why Should you Attend:
Participants will gain:
An understanding of what the global expectations are for equipment qualification and validation
An understanding of 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
Better writing and execution skills for sound protocols for equipment qualification (IQ, OQ, PQ) and process validation
Ability to qualify already existing systems more effectively and efficiently and to execute requalification’s more effectively
Ability to collect data, conduct tests, and obtain all necessary documents
An understanding of the different types of validation
An understanding of performance validation
Knowledge of the guidelines on validating analytical methods and processes
Ability to support equipment qualification and validation through the quality management system, risk analysis, calibration and maintenance, and change control
An understanding and knowledge of the principles of auditing the equipment qualification and validation
An understanding of external qualifications and validations from a contract manufacturer, and qualifications and validations by a supplier
Ability to investigate true root causes of problems and to evaluate and prioritize solutions
Ability to develop effective problem solving methods to help you asses which is best for your situation
Ability to develop successful implementation plans
Ability to perform risk assessments effectively
Areas Covered:
Regulatory Requirements and Expectations for Equipment Qualification
Europe
FDA
Global harmonization and expectations
Management of Documents, Documents Required
Validation policy
Validation Master Plan (VMP)
Documents equipment qualification
SOPs
Responsibilities
Validation team
Presumption for qualification/validation
General Aspects of Qualification
Qualification phases, DQ, IQ, OQ, PQ
Qualification of existing systems and equipment
Requalification/validation
Performance Qualification and Process Validation
SOPs
Writing a qualification protocol, content
Executing a qualification
Tests and data
Documents
Writing a qualification final report