Summary
This 3-day online training is a deep dive into the world of solids. You will obtain detailed information about the manufacturing and quality characteristics and intensify your know-how about the complex regulatory landscape. This course will cover the area of API manufacturing, as well as of finished product manufacturing with many examples (e.g. capsules, tablets, suppositories). In break-out sessions and in many case studies we will discuss different GMP challenges together and we will focus on recent findings by the authorities. Another topic will be the switch to Continuous Manufacturing – what are the requirements and how can CM be realized?
Learning Objectives
- Understand the regulatory landscape
- Overview over GMP and quality requirements for the manufacture
- Pharma 4.0 for solid manufacturing
- Challenges for the manufacturing of different solid medicinal products
- Modern process validation concepts
- How to implement effective and smart IPC concepts
- Implementation of analytical methods for solids
Key Topics
- Regulatory framework (EU-GMP Guideline, CFR, ICH guidelines e.g. Q9 and Q13, PIC/S, ISPE)
- Quality & GMP requirements
- Manufacturing challenges
- Process validation
- Pharma 4.0 and smart quality
- Analytical methods
- IPC requirements
- Case studies for significant changes and follow-ups:
- How to implement Continuous Manufacturing?
- PAT for solid manufacturing areas
- New breakout sessions during the course: You ask – the group discusses. Selected questions during the course will be discussed in the middle and at the end of each day to have an interactive course and to hear different opinions to a specific challenge
Who should attend?
Specialist from API and Solid Finished Product Manufacturing, Auditors for Solid Manufacturing Areas, Quality Assurance and Quality Control Manager, Pharmacovigilance, Regulatory Affairs Manager, Process Validation Specialist, Manufacturing Management, Process Development, Research and Development, Certified Management Consultant
Our online training experience includes
- Our client zone – a single source for all training materials as well as pre and post-training communication
- Live interactive format via the Zoom platform
- Direct interaction with the trainer
- Q&As, case studies, polls
- Training in digital format
- Digital and LinkedIn certificates
Trainers
