Event
Course Description:
Program includes three or more site visits to pharmaceutical manufacturers with active PCM installations in GMP facilities. (Site visits depend on each facility’s production schedule). To maximize learning, we complement GMP visits with tours of leading university or vendor CM test and training centers. These facilities often provide even closer access to technology demonstrations, hands-on experience, and peer exchange opportunities.Program Highlights:
- Guaranteed access to at least one GMP manufacturing site (timing based on facility approval).
- Option to visit non-GMP CM training centers for additional learning and interaction.
- Pre-tour communication and preparation facilitated by our team.
- A dedicated consultant will guide all tours.
- Post-tour remote session, to compare equipment, technology, and approaches across sites.
Please contact rsteiner@pai-qbd.com for further information or to book this course.
.Objectives:
- Understand the application of the processes covered in PCM Training for Regulatory Agencies
Who should participate:
- Regulatory reviewers, auditors, and agency staff who guide internal and external stakeholders on filing requirements and site audits.