Regulatory agencies expect pharmaceutical companies to have procedures in place to ensure suitable levels of reliability, accuracy and precision of analytical test methods. The management of analytical methods should cover lifecycle phases including design, development, validation and routine use.
Recently, managing analytical methods and procedures according to the lifecycle approach has been recommended in FDA and USP documents. The FDA guidance “Analytical Procedures and Methods Validation for Drugs and Biologics” contains a section on lifecycle management of analytical procedures. This training course will examine the new analytical procedure lifecycle guidelines. After completion you will have the knowledge and practical skills to implement recommended approaches.
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.