!New dates! BioM GLP Training – Module 1: Introduction to ALCOA++ and Data Integrity in GLP
New course dates are published now!
This GLP training module is part of the BioM GLP Course, which consists of compact intensive modules with practical examples for biotechs/ medtechs with little to no GLP experience.
The course can be booked entirely or by selected modules. For booking the entire course please go back.
Introduction:
From academic research or the pre-seed phase to the regulatory domain – this transition poses a significant challenge for many scientists and young biotechs.
Even in the early exploratory and pre-seed phase, high data quality is not optional – it is strategic: it not only increases the intrinsic value of the company itself but also enhances the value of the research and lays the foundation for results to be later adopted in a GLP-compliant manner and accepted by regulatory authorities.
While creativity and flexibility dominate in basic research, the GLP-regulated area (Good Laboratory Practice) demands the highest standards of planning, comprehensive documentation, traceability, and data integrity.
Our four training modules provide practical, hands-on guidance on this journey: from establishing solid data quality even before GLP, through concrete implementation, to common pitfalls and regulatory expectations – so your data withstands due diligence, supports regulatory submissions, and accelerates translation into the clinic.
Trainer:
Michaela Rittberger
QualifiedChemical Engineer, specialised in pharmacy. Senior Consultant and Senior Auditor in GLP, GCP, PhV, DM, IT systems and GCLP.
Founder and owner of Averen Pharmaceutical Consulting, Munich, Germany.
Brings extensive experience in national and international regulatory requirements for Good Laboratory Practice.
TOPIC:
GLP Training – Module 1: Introduction to ALCOA++ and Data Integrity in GLP
Date: Monday, 22 June 2026 from 1 p.m to 5 p.m.
Objective:
To convey the fundamentals of ALCOA++ and GLP in order to understand and implement data integrity.
Duration: 4 hours
Learning Objectives:
Backgroundon GLP, understanding of the ALCOA++ principles and their significance for GLP. Raising awareness of the importance of data and document quality.
Topics:
- Introduction to GLP: Regulatory framework, GLP guidelines.
- GLP and its relevance to data and document integrity, e.g., for preclinical studies.
- ALCOA++ principles.
- Requirements for laboratory notebooks (paper and electronic).
Typical documentation errors and their impact on inspections.
Registration
Registration is required. Please register by selecting the ticket below.
The course fees are as follows:
Ticket Options | Single Modules | Total Course (all 4 modules) |
Academy | 190 € | 600 € |
Start-ups, Early Bird Price | 290 € | 900 € |
Start-ups, Normal Price | 340 € | 1.050 € |
All prices are excl. VAT. |
For any questions, please contact us: events@bio-m.org