New approaches for conquering diseases and improving our overall well being have been driving new technologies at a faster rate in the last 20 years. This in turn have triggered changes in regulatory environments, leading to changes in the guidelines from the main regulatory agencies around the world. The guidelines for process validation have not been an exception, as they have evolved from the original “V-model” to the current and much wider definition of process validation. The different names given by the actual validation practitioners reflect their intended purpose: Validation Lifecycle, Process Validation Lifecycle, CQV Lifecycle. But are these the same? Which areas of the lifecycle have experienced the most changes and which ones have remained within the “traditional” scenarios? And, more importantly, have we reached the desired agility regarding Process Validation (in its wider use of the term) for us to demonstrate that the technologies and practices used to manufacture the newest type of dosage forms are consistently reproducible? This webinar will discuss Validation, Qualification and Process Validation from a wider perspective, showing what elements have remained true to their original purpose from a regulatory standpoint and which have started to evolve to adjust to today’s biopharmaceutical landscape.
Participants will learn about: