A large variety of laboratory equipment and analytical instruments, ranging from a simple apparatus to complex computerized systems, are used in the pharmaceutical industry to acquire data that will ensure that products meet their specifications. This course will provide an in-depth understanding of how to meet FDA expectations regarding equipment validation and qualification in the analytical laboratory.
This course is designed for those who perform, supervise, manage, audit, or oversee the validation of test methods in labs that support cGMP, GLP, and other manufacturing operations. This includes, but is not limited to, professionals in Analytical Development, Quality Control, Quality Assurance, and Validation groups. The course will also benefit those in other departments who find test method validation among their responsibilities.
Areas Covered in the Session :
- What is the purpose of laboratory equipment qualification or equipment validation?
- Qualification Plan for Equipment and Instruments
- Validation Master Plan/V-Model Approach
- Requirement from several sources (USP, Ph Eur, will be referenced and the similarities and differences will be discussed)
- Applicability, and activities associated with analytical instrument qualification through the whole system lifecycle – from design, installation, operation and performance qualifications to PM and removal from service.
Who Should Attend:
- Quality Assurance Departments
- Quality Control Departments
- Laboratory Professionals
- Research and Development Departments
- Compliance Departments
- Analytical Testing Professionals
- Production Departments
- Contract Laboratories
- Validation Departments