Validation of Automated Equipment & Process Control Systems

Validation of Automated Equipment & Process Control Systems

Scheduled

View available dates and register at the host college.

Register at Wake Technical Community College (Course #: 215626)
Class will be held at Capstone Center
Schedule
  • Monday, November 4, 2019 - 8:00am to 5:00pm
  • Tuesday, November 5, 2019 - 8:00am to 5:00pm
Instructor: Tim Tice
Tuition: $150.00

Learn the process for validation of automated equipment and process control systems typically found in the biomanufacturing or pharmaceutical facilities using GAMP 5 and other guidelines. Highly interactive activities including discussion of case studies and hands-on development of documentation are provided.

Audience

This course is designed for individuals seeking an understanding of automated equipment and process control system validations. The class is suitable for individuals seeking industry training in developing validation programs and also offers a review of the fundamentals of computer system hardware and software, how to manage electronic data and to be in compliance with GAMP 5 and meet FDA requirements.

Topics Include

  • Types of automated equipment/process control systems
  • CGMPs and regulatory requirements
  • Industry guidance documents/ documentation requirements
  • Part 11- Electronic Records/Signatures
  • GAMP 5 Life Cycle
  • Risk and Impact Assessments
  • Validation test plan and development
  • Creating validation documentation
  • Handling discrepancies/deviations during testing
  • Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)
  • Maintaining the validated state

Learning Objectives

Upon successful completion participants will be able to:

  • Determine risk assessments and test acceptance criteria based on guidance documents, the validation life cycle, requirements and system specification documents.
  • Develop test documentation for automated equipment and process control systems validation.
  • Demonstrate capabilities in testing and accurately reporting discrepancies/deviations and conclusions to meet regulatory audit expectations including traceability of testing performed as needed for audits.

Portability

This course may be taught at any location.

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Validation of Automated Equipment & Process Control Systems

Level: Advanced

Lecture HoursLab HoursTotal

Instructor Pool

Tim Tice
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