The lifecycle approach to process validation has been an expectation since 2011 but the emergence of new types of bioproducts (including cell and gene therapies), accelerated development and new manufacturing approaches have raised new challenges in meeting process validation expectations. The 2019 ISPE Process Validation Workshop will focus contemporary and novel approaches to meeting or modifying PV expectations and will shape future work to be undertaken by the ISPE Process Validation Team, already authors multiple papers on the practical implementation of the lifecycle approach to process validation. Numerous successful case studies will be included in the presentations. Panel discussion (including regulators), audience polling, and an interactive workshop will facilitate benchmarking and appreciation of the most current issues and potential solutions.
Topics for the 2019 ISPE Process Validation Workshop include:
Professionals at all levels of the industry from young professionals to the most senior executives, Communities of Practice, special interest groups, pharmaceutical industry equipment and services suppliers, and regulatory professionals.
Technical Services and Validation Professionals Process Engineers QA Management and Professionals Statisticians supporting validation Regulatory agency professionals Development scientistsRegulatory Affairs professionals Operations managers, Laboratory Managers