Product and Process Validation Online

Dates: 13th September, 2021 - 28th September, 2021 (10 days)

Duration: This course will run over 10 mornings from 09:30 - 1.00pm ( with breaks) over 3 weeks - Live online training.

Location: Online

Accreditation: QQI Product and Process Validation

Full Fee: €995

Course code: VALOL

Programme overview

This course is normally held over 5 day face to face. We are now running this course online over 10 mornings. This course  is designed to provide detailed understanding of the process of validation for regulated industries, with particular focus on validation for the manufacture of medical devices and the requirements of ISO EN 13485 and FDA QSR. The course aims to explore in some depth validation activities, the reasons of these activities and how best to meet these requirements.

All of these topics will be expanded on and Case Studies/Examples will be included in order to best communicate the method for validation.

This programme is a QQI component (minor) award, certified at Level 5 on the national framework of qualifications – see www.nfq.ie  and is an elective component of major awards

 

 

 

 

 

Recommended follow on courses are:

Who is the course for

  • Validation Engineers
  • Quality Engineers
  • Personnel planning validation activities
  • This course is designed for Senior Management, Quality Managers, Quality Engineers, QA and Regulatory personnel working on QMS’s in industry.

Learning outcomes

  • Understand regulatory requirements around Validation
  • Understand in depth process validation activities, including cleaning and software
  • Understand structure of Protocols, Test Reports, Master Validation Plan, User Requirement Spec

Course content

 

Module 1Background and HistoryModule 14Validation of Tooling
Module 2Current Legislative RequirementsModule 15 Process Validation
Module 3Validation ManagementModule 16Exercise
Module 4ExerciseModule 17Change Control
Module 5Validation Description TypeModule 18FMEA
Module 6ExerciseModule 19Exercise
Module 7When to Qualify and ValidateModule 20DOE
Module 8User Requirement SpecModule 21Software Validation
Module 9Test ProtocolModule 22Design Control Validation
Module 10ExerciseModule 23Clinical Validation
Module 11Alignment of Operation, Validation and Calibration parametersModule 24Cleaning Validation
Module 12Validation Test ReportModule 25Validation Certificate
Module 13Operational Qualification

Trainer Profile

TP Lowry has over thirty years in medical device and pharma industries working as Analyst, Engineer, Quality Manager to Operations Director. Consultant for the past sixteen years.

MBA , Doctor of Quality Management

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