Request this Course
Submit this form to request this course to be scheduled.
Validation of Automated Equipment & Process Control Systems
Scheduled
View available dates and register at the host college.
Starts: November 4, 2019
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.
Level: Advanced
Lecture HoursLab HoursTotal
Instructor Pool
Tim Tice
Related Information
Video
Capstone Center in Raleigh is BioNetwork's premiere worker training facility. At Capstone,... more
Capstone Center in Raleigh is BioNetwork's premiere worker training facility. At Capstone,... more
Video
This video surveys examples of life science-related training provided by NC Community Colleges for... more
This video surveys examples of life science-related training provided by NC Community Colleges for... more
eLearning
This eLearning module will give you an understanding of the process used to develop drugs and why... more
This eLearning module will give you an understanding of the process used to develop drugs and why... more
eLearning
In this eLearning module you will learn about the federal and international regulations that... more
In this eLearning module you will learn about the federal and international regulations that... more
- 1 of 5
- >