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

1. Start2Pharma

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

2. Technical Concept Training

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

3. PM & Management Training

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