Process Validation & Equipment Validation

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Organisation profile

SQT are a specialist provider of bespoke training programmes. For over 30 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