The final version of EU GMP Annex 1 is an opportunity for industry to apply solutions that emphasize advanced technologies and allow Pharma companies to speed up their processes, reduce human error to ensure that final products are protected from microbial, particulate and pyrogen contamination and are safe for patients. This webinar will discuss the requirements that may impact your organization.
- Contamination Control Strategy (CCS):
An overall documented plan to keep your aseptic manufacturing environment under control
Understanding the differences between cleanroom classification, qualification, and monitoring
- Implementation of new controls:
We will discuss Pre-use, post-sterilization integrity testing (PUPSIT) of sterile filters and container closure integrity testing of containers
- Advanced Technologies:
We will cover advanced technologies like barrier systems, single-use systems, and closed systems for cell/gene therapy
Who should participate:
Drug manufacturing, pharmaceutical manufacturing, biomanufacturing, biologics organizations; Job function: process design, quality assurance (QA), quality control (QC), operations managers, quality management, pharmaceutical quality directors, MHA, MPH.