Organisation profile
For over 30 years, SQT Training Ltd has been providing a unique combination of high quality, accredited, practical training, delivered by leading industry experts and supported by the most up to date learning technology and tools. Our hands-on, engaging, real world approach to learning is fully supported and can be delivered as virtual, classroom based or blended training.
We provide both Public & tailored In-Company training 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 virtual training course
Assessment & certification
SQT Certificate of Attendance
Who should attend
Personnel in the Medical Device,
Pharmaceutical and API sectors who are engaged in validation activities. QA
& regulatory staff involved in auditing validation protocols and reports.
Senior Management who need to allocate validation resources & review &
approve validation programmes.
Website
https://www.sqt-training.com/programme/process-validation-equipment-validation/