Course description
Introduction to Validation
Pharmaceutical validation has been a regulatory requirement for nearly 40 years and continues to attract significant regulatory attention. As well as the obvious benefits of compliance, validation also offers significant business advantages because well understood, capable and controlled processes form the basis of day-to-day manufacturing and testing operations.
This series of four bite-size courses (approximately two hours each) provides anyone new to the topic of validation with an overview of four core areas: cleaning, analytical, process and equipment, and facilities, utilities and qualification.
Suitability - Who should attend?
This training is an ideal introduction to validation for people who are new to the subject and are directly involved in or responsible for validation in the pharmaceutical industry.
Training Course Content
By the end of the courses you will understand:
- The current regulatory expectations relating to:
- Analytical validation
- Equipment, facilities and utilities qualification
- Process validation
- Cleaning validation
- Validation documentation requirements
- How each of the validation disciplines should be executed at your workplace
- Validation maintenance requirements
Course Content
Each two-hour virtual course provides an overview of the relevant guidance for each validation area and takes you through an interactive session where you will learn:
- Cleaning: How to design your cleaning process, analytical methods and specifications to be used during cleaning validation as well as how to maintain the validated state
- Analytical: Method verification, method validation, system suitability and method transfer
- Process: The principle of validation, the validation lifecycle, quality by design, execution of process validation and continuous process verification
- Equipment, facilities and utilities: The different stages of qualification from the URS to the performance qualification and how they should be executed
Course delivery details
Each of the four mini courses in the series uses scenarios and interactivity to support and strengthen the learnings.
Why choose NSF International, Health Sciences
Trained over 1,300 delegates on our CQI and IRCA certified GMP PQS lead auditor training course
Provided expert health sciences training for over 30 years
More people have become ‘Qualified Persons’ in Europe through our training programme than any other training provider
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Expenses
Discounts offered to NHS staff, regulators and charities.
Book all four bite-size validation courses together to receive an £85 discount and free access to our Computerised Systems Validation eLearning course.