Overview:
Are you trying to interpret and understand more precisely what validation means? If you read regulatory requirements regarding European, American or other countries, does it still leave you puzzled?
It could be that you’re new to the company or role. You could work for a supplier and want to learn and appreciate what validation means for you and your customers.
The Understanding Validation (1 Day) Training is a foundation-based course which will help increase your understanding of what validation means to the healthcare manufacturing industry.
When you have completed the course, you will have an appreciation of the different terms and application of validation for pharmaceutical and medical device manufacturers. You’ll also understand how regulatory requirements affect companies, and be able to identify validation activities where mistakes, and their subsequent consequences, can occur.
Content:
Investigate the history and requirements for validation
Understand the terms and the application of validation
Discuss the terms used
Evaluate the key stages of validation
Use the basic 'V' model for a simple approach
View a CD video and answer questions
How far does Good Engineering Practice go towards meeting compliance?
Use case studies to explore the causes and implications of non compliant validation