Training & Knowledge Transfer
Structured GMP training aligned with regulatory expectations and practical application.
Training & Knowledge Transfer
Training and knowledge transfer services are designed to strengthen understanding of GMP expectations and support personnel in applying these principles in daily practice.
Training is structured, practical, and aligned with applicable regulatory frameworks.
Where appropriate, training sessions may be supported by written summaries or reference documentation.
All training sessions are available in both English and German.
Training Overview
Training offerings cover essential aspects of GMP and related compliance topics, with emphasis on practical understanding, inspection relevance, and real-world applicability.
Each session is tailored to the intended audience, with content focus determined by the organization’s needs.
GMP Fundamentals
An introductory training module focused on the foundational principles of Good Manufacturing Practice.
Scope includes:
GMP purpose and structure
Core regulatory references and expectations
Overview of quality system elements
Roles and responsibilities within a GMP environment
This foundational session provides a solid basis for participants who are new to GMP or require a structured overview.
Advanced GMP Topics
Advanced training modules for personnel with existing GMP knowledge, focusing on deeper insight into complex compliance areas.
Scope includes:
process risk considerations
integration of quality systems
documentation and data integrity practices
understanding audit findings and regulatory expectations
Advanced sessions may be adapted to specific operational contexts.
Inspection Preparation & Audit Behavior
Training designed to support teams in inspection readiness and effective interaction during regulatory audits.
Scope includes:
common inspection focus areas
demonstration of evidence
communication during audits
roles and responsibilities in an inspection
This training emphasises real-world inspection relevance and practical preparation.
Data Integrity & Documentation Practice
Focused training aimed at strengthening understanding of data integrity principles and documentation control.
Scope includes:
ALCOA+ data integrity concepts
documentation lifecycle and control
common risk areas
traceability and audit readiness
Training may be accompanied by written reference material where appropriate.
Custom Training Modules
Customized training programs can be developed to address specific needs within your organization.
Topics may include:
site-specific quality system challenges
GMP for specialized operations (e.g., GDP, GACP)
integration of digital systems within GMP frameworks
Custom modules are defined in consultation with the organization and aligned with applicable regulatory expectations.
Professional Exchange
f you would like to discuss your training needs, potential focus areas, or how training can support your compliance goals, an initial professional exchange is possible.