“Combining science with regulatory knowledge for optimized systemic solutions.” ™ 

FDA Regulatory Compliance Advisors, Inc.



The preparation and planning for manufacturing drug and biological products require developing and implementing an adequate  control strategy. Understanding and implementing a process validation lifecycle for the manufacture of pharmaceutical products facilitates, not only the establishment of a robust control strategy, but also a risk management system to ensure the consistent quality of drug products.  

Effective process validation is essential for ensuring pharmaceutical drugs quality as each drug produced should be fit for its intended use. Applying Quality by Design principles (QbD) and understanding and controlling the sources of process and product variation will facilitate maintaining processes in the commercial phase of the Validation Lifecycle in a state of control.  

Participants will understand and apply the acquired knowledge during the collection and evaluation of data, from the process design stage through commercial production, establishing scientific evidence that a manufacturing process is capable of consistently delivering a quality product.

Participants will also understand how the implementation of a quality system that incorporates risk management principles is the foundation for continual process and product improvement that supports business efficiency. 



  • Understanding Process Parameters
  • To what extent can process parameters be changed?
  • Identifying which process parameters are critical
  • How to set clear product specifications
  • How is the sample size determined? 
  • How to document non-conformances ​during validation
  • Common process validation mistakes