Cleaning Validation

Dates: To be verified

Duration: 2 Days

Location: 7 Centre Court, Blyry Business and Commercial Park, Athlone.

Accreditation: Certificate of Attendance

Full Fee: €795 including course manual, lunch and refreshments.

Programme overview

This course is designed to provide detailed understanding of cleaning validation for regulated industries, with particular focus on medical device and pharmaceutical cleaning activities.

We can deliver a shorter tailored programme at our centre in Athlone for you/ or on-site if you have injection moulding capability there.

Learning outcomes

  • Understand regulatory requirements
  • Understand key elements that should be in cleaning procedure
  • Understand various cleaning methods
  • Layout of cleaning protocol

Who is the course for

  • Validation Engineers
  • Quality Engineers
  • Personnel designing cleaning methods

Content

Module 1: Validation Introduction
Module 2: Regulatory Background – FDA,HPRA approach
Module 3: Designing a cleaning Procedure
Module 4: Basic Chemistry of Cleaning
Module 5: Best Industry Approach to Cleaning Studies
Module 6: Cleaning Methods
Module 7: Calculation of carry over limits
Module 8: Development of Bracketing procedures
Module 9: Hold Times (DEHT),(CEHT)
Module 10: Identification of Hard to Clean Places
Module 11: Documentation
Module 12: Cleaning of Dedicated equipment

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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