Introduction Validation Basics
Why this topic?
How do your processes, applications and equipment work? Are you in full control? Will everything work the same after the recovery of a breakdown? In other words, are you able to guarantee that your processes, applications, equipment and products meet the applicable quality requirements and comply with all regulations?
Validation is a way to prove that a system or process works correctly, and complies with fixed acceptance criteria. Each pharmaceutical or cosmetic product needs a quality control process to guarantee that the products meet quality requirements and comply with regulations. A validation process results in a file with certifications that prove to auditors that, by means of various tests, you comply with the required criteria.
What can you expect during the training?
- Learn the basic principles of and discuss the possibilities for your validation process.
- Gain insight into the best start for your validation process and required information and equipment.
- Learn the definition of validation related terms, like URS certification, impact assessment or risk analysis.
- Discover how to design a validation test.
What is the result in your daily work?
A thorough basis for the start or expansion of validation processes and knowledge of the most important aspects of validation is important to deliver high-quality products within the pharmaceutical or cosmetics industry that meet quality requirements.
- Participants gain insight into the amount of effort and time validation takes.
- Participants learn what validation is and understand the importance of accurate validation processes for their organisation.
- Participants are introduced to a risk-based approach and ASTM E2500.
In addition to this training, we offer a Pharmaceutical Engineer training to extend your knowledge to the technical aspects. We also explore the subject and the issues we are facing in the field in greater detail. This may lead to internal or external assignments.
This training is intended for people in the life sciences (especially pharmaceuticals) or cosmetics sector with little or no experience in validation and are planning to get busy with validation.