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 validation in the context of healthcare and pharmaceutical manufacturing?
Validation is the process of ensuring that systems, processes, and products meet specified requirements and function as intended in real-world applications. This ensures compliance with regulatory standards and helps prevent risks related to product quality and patient safety.
How does this course cover regulatory requirements?
This course provides an overview of global regulatory standards, with a focus on European and American regulations. You'll learn about the expectations these bodies set for validation, including key concepts like training, testing, and validation splits.
Who should attend this training?
This course is designed for anyone involved in validation processes, especially those new to the healthcare or pharmaceutical industries. It’s beneficial for quality assurance professionals, regulatory staff, engineers, and suppliers looking to understand how validation impacts their role and responsibilities.
Will I learn about the different types of validation (e.g., process validation, computer system validation)?
Yes, this course introduces the various types of validation, including process and computer system validation. It also covers how these types are applied in the pharmaceutical and medical device sectors to meet compliance standards.
How does this course approach validation training?
The course uses the 'V' model—a simplified approach that breaks down validation into manageable stages. Through case studies and practical examples, you’ll learn how to apply validation in different scenarios and avoid common errors.
What’s the significance of using case studies in this course?
Case studies offer insights into real-world applications of validation. Analysing actual scenarios allows participants to better understand the implications of non-compliance and develop skills to improve validation practices.
What are the key skills I’ll gain from this training?
Upon completion, you’ll be able to understand core validation terms, identify key validation stages, and apply best practices for compliance. This training will help you recognise potential pitfalls and develop methods for continuous validation improvements.
How does this training fit into larger compliance strategies?
This course emphasises how validation plays a critical role in broader regulatory compliance and risk management strategies. You’ll learn how validation connects with Good Engineering Practice and other quality frameworks to uphold industry standards.
Are there prerequisites for this course?
There are no formal prerequisites. However, familiarity with basic compliance or quality assurance concepts may help you get the most out of the training.
Is this course available online?
Currently, this course is offered in-person for hands-on learning. Future sessions may be available online based on demand.
