Process Validation & Equipment Validation

Organisation profile

SQT are a specialist provider of bespoke training programmes. For over 25 years, we’ve brought the latest thinking, the leading techniques & the most experienced industry experts into ambitious organisations, large & small, throughout Ireland & beyond.

In-House & Public courses in the areas of Continual Process Improvement, Environment & Energy Management, Food Safety, Health & Safety, Hospitals / Medical, Laboratory,Leadership, Lean Six Sigma, Life Sciences, Project Management & Quality  

Training aim

•             Recognise the regulatory requirements for process validation

•             Appreciate the benefits of conducting validation studies

•             Demonstrate an understanding of the key elements of process validation

Learning objectives

•             Appreciate European & FDA Guidance publications on process validation

•             Determine where to use process capability and other statistical methods during validation studies

•             Demonstrate an understanding of the approach adopted by the Global Harmonisation Task Force regarding verification and validation

•             Design a validation master plan, validation protocols & reports

•             Describe the main requirements for maintaining a state of validation    

Course outline

Process Validation is required in the Pharmaceutical, API and Medical Device Healthcare Sectors. A comprehensive, well thought-out approach to validation is a key element in assisting any company meet European & US FDA regulatory inspection requirements. This course looks at regulatory guidances & recent trends in validation.

Trainer's profile

Our expert Life Science tutor team comprises of:

John Lafferty

Gerry Burke and

Kevina O'Donoghue

All are highly qualified and have many years' experience within the Life Science sector

Course duration

 2 day training course

Assessment & certification

SQT Certificate of Attendance

Who should attend

•             Personnel in the Pharmaceutical, API & Medical Device business sectors who are engaged in validation activities

•             QA & regulatory staff involved in auditing validation protocols and reports

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