GxP commonly refers to the standard quality management systems in pharmaceutical, chemical, biotechnology, food, and medical device industries. This three-day training offers a comprehensive overview of internationally required quality assurance systems in regulated research and development (R&D) focusing on Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP). Participants will learn about study processes, data management, regulatory requirements, documentation and data integrity practices, as well as audits and inspections. Practical examples provide valuable insights into research, development and production.

The course is particularly suitable for graduates, doctoral students and postdocs from the fields of medicine, biology, chemistry and life sciences, as well as for anyone seeking insight into quality assurance in pharmaceutical and biotech companies.

Duration: 3 days
Planned dates: May 7th – May 9th, 2025
Fee : 990,- EUR
Fee Graduates _{(Graduates, Doctoral Students and Postdocs)}*: 690,- EUR

Registration
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By attending this seminar, you will receive proof of a GxP-compliant training.
The following topics will be covered:

• Quality Management in Regulated Research, Development and Production
• Regulatory Basics of GLP: Scope, Objectives, and Principles
• Structure and Organizational setup of GLP Test Facilities
• GLP Study Process, Study Plans, Documentation and Data Management, Archiving, Audits and Regulatory
• Inspections
• Fundamentals of GCP, Regulatory an Ethical Basics, Objectives and Responsibilities
• Phases of GCP Clinical Trials, Study Design and selected Study Types.
• Special Topic: Medical Devices and Combination Products
• Introduction to GMP: Drug Approval and Regulatory Basics
• Roles in a GMP Environment; Quality Management and Documentation
• General Requirements, Requirements in R&D, in Quality Control and in Production
• GMP Audits and Inspections
• Good Distributional Practice (GDP): Introduction and Practical Examples
• Requirements for Data Integrity and Validation of Computerized Systems under GxP