Training

Considering training?

GRA provides training to the biotech sector for all levels of experience and knowledge delivering on-site training on all areas of CMC including technical and regulatory.  Below you find a list covering a variety of areas in which we are able to provide training.

• Assay Validation, learn what is required to qualify and validate assays.  Understand how to build economic and effective experiments that assess ICH characteristics in one experiment.
• Biopharmaceutical process development, understand the importance of building logical & efficient processes, from cell banks, to upstream, through downstream into formulation.
• Bioassay development and optimisation, build an understanding of the particular issues surrounding bioassay development understanding noise within the assays and how to manage it.
• Process and assay validation, training in what is required to validate your process.
• Designing and analysing stability studies, see the important of designing efficient stability studies and building shelf life models.
• Use of Quality by Design & DoE, learn what QbD is all about and how essential it is to build your processes and assays in line with it.
• Design of Experiments (DoE), build on QbD  knowledge learning how to build efficient screening designs and build design and control space to ensure your process and assays are optimal and robust.
• Essentials for biotech startups, learn the basics of biotech companies, whether thinking of starting or investing in one.
• Build an appropriate CMC package, regulatory training of all elements that must be considered to build a comprehensive CMC package.

GRA can help you understand beyond the fundamentals into advanced understanding of the challenges that biopharmaceutical development presents.