Event
Course Description:
This on-site training will focus on oral solid dosage products and drug substances and cover topics from an overview of PCM, a discussion of pertinent inspection concerns, regulatory compliance consideration, according to ICHQ13 and technical aspects including process development, process analytical technology (PAT), and statistical approaches.
Day 1 – PCM Overview
- Overview of CM landscape
- Quality & Regulatory Compliance AspectsControl Strategy
- Equipment & Automation
- Data management & Data integrity
Days 2-3 – Scientific Training
- Process Development
- Process Analytical Technology (PAT)
- Real-Time-Release (RTR)
Day 4 – Expert Training in Specific Fields
- Inspection Considerations
- Cleaning and Containment
- Quality Aspects
A final detailed curriculum will be tailored to the customer’s needs and material provided in electronic form (pdf).Please contact rsteiner@pai-qbd.com for further information or to book this course.
.Objectives:
- Understand the current global landscape of CM and lead users.
- Identify use cases of CM for OSD as well as Drug Substance applications.
- Understand and review drug filings for CM applications.
- Perform site inspections related to CM line installations.
Who should participate:
- Regulatory reviewers, auditors, and agency staff who guide internal and external stakeholders on filing requirements and site audits.