Providing an overview of the quality and regulatory issues surrounding the development and production of biopharmaceuticals for global use, this one day workshop is suitable for
QA professionals and newly-appointed managers who are moving into biopharmaceuticals, and regulatory professionals who need to understand the quality issues associated with
their manufacture. It covers the regulatory approaches used in Europe and the US, differences between small molecule drugs and biopharmaceuticals from a quality point of view, the different types of biopharmaceutical and associated quality issues, the importance of the manufacturing process – production systems, issues associated with scaling up, the
importance of facilities design, the role of the genetic construct in reproducible manufacturing and the use of Master Cell Banks and Master Working Banks.
QA professionals and newly-appointed managers who are moving into biopharmaceuticals, and regulatory professionals who need to understand the quality issues associated with
their manufacture. It covers the regulatory approaches used in Europe and the US, differences between small molecule drugs and biopharmaceuticals from a quality point of view, the different types of biopharmaceutical and associated quality issues, the importance of the manufacturing process – production systems, issues associated with scaling up, the
importance of facilities design, the role of the genetic construct in reproducible manufacturing and the use of Master Cell Banks and Master Working Banks.
