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.
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 and biologics
- How to implement effective and smart IPC concepts
- Implementation of analytical methods for solids
Key Topics
- Regulatory framework
- Quality & GMP requirements
- Manufacturing challenges
- Process validation
- Pharma 4.0 and smart quality
- Analytical methods
- IPC requirements
Who should attend?
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
- Revisit recorded sessions for 30 days
- Training in digital format
- Digital and LinkedIn certificates
Trainers
Dr. Felix Tobias Kern is the Associate Director - Head of Compliance Launch and Technology Center at the Merck KGaA in Darmstadt (Germany). He studied pharmacy in Mainz (Germany) and graduated at the Ludwig-Maximilians-University in Munich (Germany). He is an expert pharmacist for pharmaceutical analytics and pharmaceutical technology.
Quality Requirements for Solids
Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.
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