!New dates! BioM GLP Course (with Training Certificates)
New course dates are published now!
Compact intensive modules with practical examples for biotechs/ medtechs with little to no GLP experience.
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
Qualified Chemical 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.
TOPICS:
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:
Background on 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.
GLP Training – Module 2: GLP-Compliant Laboratory Practice and SOPs
Date: Monday, 6 July 2026 from 1 p.m. to 5 p.m.
Objective:
To convey the practical requirements for laboratory practice, including organization, personnel, equipment, reagents, and SOPs, for biotechs/medtechs to ensure GLP compliance.
Duration: 4 hours
Learning Objectives:
Understanding of GLP requirements for laboratory practice.
Ability to use SOPs and correctly document equipment/reagents.
Topics:
- Organization and personnel (e.g., roles of study director, researcher).
- Standard Operating Procedures (SOPs): Development and use of SOPs for consistent data.
- Equipment and reagents.
- Labeling and documentation of reagents, e.g., in ELNs for ALCOA++ compliance.
GLP Training – Module 3: Test Systems, Study Conduct, and Reporting
Date: Friday, 10 July 2026 from 9 a.m. to 1 p.m.
Objective:
To convey the GLP requirements for test systems, study conduct, and reporting of study results for biotechs/medtechs.
Duration: 4 hours
Learning Objectives:
Understanding of the requirements for test systems and study conduct. Initial ability to create GLP-compliant study plans and reports.
Topics:
- Test systems:
Requirements for biological/physical test systems, documentation of test systems in ELNs.
Study conduct: - Introduction to creating and implementing a GLP-compliant study plan, documentation of study progress in ELNs (e.g., collaboration with the laboratory in using ILAD for automated data capture).
Reporting of study results: - Requirements for final reports (completeness, accuracy); structure of a GLP report (data, methods, results, QA statement); documentation in paperless systems (ELNs).
GLP Training – Module 4: Archiving of Records and Materials, and Electronic Data Processing Systems
Date: Monday, 13 July 2026 from 1 p.m. to 5 p.m.
Objective:
To convey the GLP requirements for archiving records and materials as well as the use and validation of electronic data processing systems to ensure data integrity.
Duration: 4 hours
Learning Objectives:
Understanding of archiving requirements for electronic and paper-based systems. Ability to ensure data integrity in ELNs/ILAD.
Topics:
- Archiving of records and materials: Requirements for long-term storage; archiving in paperless environments (ELN data, metadata, audit trails); archiving of materials (test/reference items, samples); collaboration with the laboratory regarding archiving responsibilities.
- Electronic data processing systems: Validation of ELNs/ILAD (data security, audit trails); role of the researcher in using validated systems.
Registration
Registration is required. Please register here for the entire GLP course (all four modules) by selecting the ticket below.
To book individual modules, click on the respective module link below to register for it separately:
Module 1 - 22 June 2026: www.bio-m.org/biom-glp-training-module-1
Module 2 - 06 July 2026: www.bio-m.org/biom-glp-training-module-2
Module 3 - 10 July 2026: www.bio-m.org/biom-glp-training-module-3
Module 4 - 13 July 2026: www.bio-m.org/biom-glp-training-module-4
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