Validation of Automated Equipment & Process Control Systems

Validation of Automated Equipment & Process Control Systems
850 Oval Drive
Raleigh, NC 27695

Description

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.

Topics Include

This 2 day,16 hour course, covers the following topics:

  • Types of automated equipment/process control systems
  • GMPS 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.

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.

Instructor(s)
Tim Tice
Class Dates
  • September 24, 2018
  • September 25, 2018
Class Days & Times
  • Mon - 8:00 AM to 5:00 PM
  • Tue - 8:00 AM to 5:00 PM
Class Level
Advanced
Lecture Hours
10.00
Lab Hours
6.00
Total Contact Hours
16
Building
BTEC
Room
124
Format
Face-to-Face
Course ID
197992