Available Dates
If you would like to attend this course and it is not planned or full, please contact us or call us on 01642 222232 to make other arrangements.
FAQs
What is the primary goal of this validation training course?
This course aims to provide participants with a comprehensive understanding of validation, regulatory requirements, and engineering project deliverables in the context of healthcare and pharmaceutical manufacturing. It helps professionals ensure that equipment and processes meet regulatory standards for quality and compliance.
Who is this course suitable for?
This training is ideal for anyone involved in validation, compliance, quality assurance, or engineering projects in regulated industries. It’s particularly beneficial for those new to validation or needing a structured approach to understand regulatory requirements and risk management.
How does this course address regulatory requirements?
The course provides a detailed overview of European and American regulatory expectations and shows how validation activities must align with these standards to ensure compliance. We’ll explore how requirements shape validation processes in pharmaceutical and medical device sectors.
What is the 'V' model, and why is it used?
The 'V' model is a structured approach to validation that visually represents the stages of validation, from planning to qualification. It simplifies complex processes, ensuring that each stage builds on the previous one to maintain consistency and compliance.
What does Day 2 focus on?
Day 2 expands on engineering project management, including Factory Acceptance Testing (FAT), documentation practices, and change control. It addresses how project activities and deliverables impact the validation lifecycle and product quality.
How will risk management be covered?
The course introduces risk management in the context of validation, focusing on identifying and mitigating risks throughout the equipment/system lifecycle. This helps prevent compliance issues and ensures project integrity.
Why are case studies included in the training?
Case studies allow participants to see real-world examples of non-compliant validation. By analysing these scenarios, you’ll understand common pitfalls and develop skills to create actionable improvements in your organisation.
Will the course cover specific types of validation, such as process and computer system validation?
Yes, we cover key types of validation relevant to pharmaceuticals and medical devices, including process validation, computer system validation, and engineering practices that meet compliance standards.
Are there prerequisites for this course?
No formal prerequisites are required. However, a basic understanding of quality assurance or engineering principles may be beneficial.
Is there an online option available for this course?
Currently, this course is offered as an in-person workshop to facilitate hands-on learning and interaction. However, an online version may be available in the future based on interest.
