This webinar will guide you through the expctations of regulators when filling a Pharmaceurtical Continuous Manufacturing (PCM) process for an Oral Solid Dose (OSD) drug produt. Starting from the difference bereen a batch and a continuous process we cover the impact of evidence that needs to be generated so that the quality of the released product is assured, and how the will evolve throughout the drug product lifecycle. FDA, EMA, ICH [Q13].

Subject area:
cGMP

Objectives (If applicable):
N/A

Target Audience (If applicable):
Drug manufacturing, pharmaceutical manufacturing, biologics organizations; Job function: quality assurance (QA), quality control (QC), regulatory, operations managers, quality management, pharmaceutical quality directors, MHA, MPH. managers, scientists, OSD, direct product, quality