DUBLIN–(BUSINESS WIRE)–The “FDA and EU Process Validation and Equipment Qualification Training Course” training has been added to ResearchAndMarkets.com’s offering.
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.
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 assess which is best for your situation
- Ability to develop successful implementation plans
- Ability to perform risk assessments effectively
Key Topics Covered:
DAY 1
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
General Aspects of Qualification
Qualification phases, DQ, IQ, OQ, PQ
- Design Qualification
- Installation Qualification
- Operational Qualification
- Process Qualification
- Performance Qualification
Questions / Comments / Discussion
DAY 2
Operational Qualification of existing systems and equipment
- Requalification/validation
Performance Qualification and Process Validation
Writing SOPs
- Writing a qualification protocol, content
Executing a qualification
Tests and data
Documents and writing a qualification report
Final Questions / Comments / Discussion
For more information about this training visit https://www.researchandmarkets.com/r/w97y5h.
Contacts
ResearchAndMarkets.com
Laura Wood, Senior Press Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
