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Biopharmaceutical manufacturing processes must be characterised, qualified and validated to ensure product safety. EMA and FDA regulators want to see evidence of an adequate control strategy for both upstream and downstream processes. Regulators also want to see that you have appropriate steps for continuous verification and validation post approval.
This bioprocess training course examines the ICH, EMA and FDA guidances you must follow to ensure your product is safe and compliant. You will examine the three stages of process validation, so you know what is required and how to implement it. You will have the confidence to implement a control strategy and conduct a process performance qualification. The course will also provide you with knowledge in Quality by Design (QbD), conducting risk assessments and continuous verification.
With the Educo Post Learning Implementation Plan (PLIP) you will have the framework to apply and implement the knowledge acquired in the training, supporting you in your development. Learn more about how we deliver live online training.
What is included in a live online course?
- Direct access to an expert trainer
- Interactive and engaging sessions with exercises and discussions
- Bitesize learning
- Access to the Educo Life Sciences Training Portal
- Unlimited access to the recordings for 4 weeks after the last session
- Full access to the Educo Post Learning Implementation Plan (PLIP)
- A validated certificate of attendance available for you to download and file