Cleaning Validation

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1 Day/s

CPD Hours: 7

Online, in-house

This is a practical based course. We explore the issues and pitfalls you may experience when performing Cleaning Validation. Help, guidance and training is given on techniques to overcome the issues in order to achieve a successful outcome.


After an introduction to the overall objectives, the course then covers process design, pitfalls and associated validation issues including sampling and testing. The course is designed so that the most important and fundamental issues associated with cleaning validation or verification are broken down and explained.


This training is designed for those with responsibility for the design, execution, or validation of cleaning processes which may include operations managers and personnel, validation specialists, Quality Assurance and Quality Control managers, production engineers, microbiologists, quality systems auditors and supplier auditors.
This course covers the following topics :


  • Why validate
  • Process design
  • Walking the plant
  • Documentation
  • Qualification strategies
  • Residues and limits (inc. MACO)
  • Sampling and testing
  • Analytical method validation
  • Maintaining validated status
  • Special considerations
  • Good/bad practices

    By the end of the course you will:


    • Appreciate the need to validate or verify your plant cleaning
    • Fully understand the documentation and legal requirements
    • Understand and be able to carry out the important operation of ‘Walking the Plant’
    • Recognise good and bad practices
    • Be able to calculate acceptance criteria
    • Be able to clearly identify what constitutes ‘visually clean’
    • Be aware of the issues surrounding sampling and testing techniques
    • Appreciate the importance of analytical method validation

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Special offer

Helping your training budget go further

We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.

Meet the tutors

John Spenn

John Spenn is an experienced quality professional with over 25 years in the biopharmaceutical / life sciences industry. John has held senior strategic management and leadership roles and has extensive knowledge and experience in quality management and regulatory processes as well as CQV lifecycle for equipment, facilities, utilities, computer systems, sterilisation and cleaning validation. John is currently a director at Dorset Quality Services offering validation and quality consultancy services to the pharmaceutical and life sciences industry. His previous positions include Associate Director and Head of Validation at Lonza Biologics, Cleaning and Process Validation Manager at Porton Biopharma and Validation Manager at Public Health England.

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