GMP in Biopharmaceutical Development (1) - From Lab Table to Clinic
This course gives answers to the question of which regulatory aspects are important throughout the product development cycle. What are the GMP requirements at various stages of product development (research, animal studies, clinical phases I, II & III)?
- 1 day
- Course fee
- € 895 (excl. VAT)
This is a modular designed training wherein various GMP issues that are important for the development process of biopharmaceutical products are dealt with.
This training also discusses the different regulatory standards required during the various phases of the process (development, animal research, clinical phases I, II and III).
The training "GMP in Biopharmaceutical Development - From lab table to clinic" is presented in 2 modules that can also be followed seperately:
- Module 1: GMP in Biopharmaceutical Development (1) (1 day).
- Module 2: GMP in Biopharmaceutical Development (2) (2 days). You can read more about the second module of the course here.
Module 1 is an introduction to GMP. GMP is a standard for the production/analysis of medicines including the preparation/analysis of clinical test material (Investigational Medicinal Product - IMP).
It is also important for companies to have knowledge of GMP during their research phase. On the one hand these companies must deliver products that will be produced/tested under the GMP system at a later stage and, on the other hand, GMP is a quality control system and certain features of such a QC system are also applicable within a research environment.
The subjects to be discussed are:
- Introduction to GMP
- Change Control
- Outsourcing work
- Gaining understanding and knowledge of GMP
- Understanding the importance of process flows and structures within the GMP system
- Having practical and simple reference points to enable implementation of these systems within R&D
This training is developed for people who work within an R&D environment (laboratory/ production) who would like to know more about GMP, for example, to be able to adapt and adjust their development processes in accordance with future demands.
It will also be useful for those staff who work in an R&D oriented company that make or play a role in the manufacture and/or analysis of clinical material.
In fact, the training is also most suited to those staff who just want to know more about GMP or work in a pharmaceutical company but have not (yet) worked under GMP conditions.
GMP, deviations / OOS, change control, training, documentation, outsourcing work
Carry out deviation research
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