Training
learning program
Life long learning
Understand the drug product industry. From drug discovery to manufacturing to supply: how to guarantee drug quality.
Project engineers in new pharma Operators & Technicians Technical experts Advanced Pharma experts
Compliance Awareness
GMP & legal aspects
GMP & Data integrity
QMS (Deviation handling, Human error)
Basics in GMP
Quality in the Life cycle of a drug product
Contamination Awareness
Microbiology & contamination control
Document awareness & skills
Good documentation the basics
Technical writing for SOP’s & Work Instructions
Technical writing advanced & GDP advanced
Basics in Validation & Change Management
Good Process Design
Aseptic Manufacturing
Manufacturing of Biologicals
Applying in-process controls – PAT
Container Integrity / Particle inspection
Good Validation Practices
Process Validation/QBD
Statistics: DOE, Statistical Process Control & acceptance sampling
Good Engineering Practices
Basics in cleanroom design
Facilities – HVAC Water systems
Filtration & filter Integrity
Overview of Equipment Aseptic Manufacturing
Overview of Equipment Biologicals
System validation/verification/ASTM
Computer system validation
Cleanroom Control
Environmental standards & cleanrooms
Sterilization Technology & Media Fill
Cleaning applications
Sterilization validation
Cleaning validation
Good Laboratory Practices
Analytical Instruments
Analytical methods
Out of Specification Results
Technology transfer
Analytical Instrum. (C&Q & Calibration)
Analytical method validation
CSV Lab systems & Data Integrity
Statistics
Quality Risk Management
QRM the basics
QRM facilitators
Operational Excellence
Yellow Belt
Orange Belt
Streamline documentation
Successful transfers
Quality Management
Human error reduction – Awareness for managers
Human error reduction – In practice
Audit behaviour
Q10 – QMS training
Human Excellence
Working in cross functional teams
Conflict handling through human typology (Enneagram)
Stress & burn-out awareness
Clear objective setting