Our Quality Associates have worked with organizations to author and revise SOPs and training modules to meet regulatory standards, and in response to regulatory findings. We have implemented quality improvements across multiple departments all to improve on meeting disposition timelines. Provided trainings across multiple sites for various clients. Our experts have also have experience working with outside vendors to support product disposition.
We also have assisted in the oversight of FMS (Flexible Manufacturing Systems) of biologic and anti-sense oligonucleotides. A flexible system with capability to rapidly manufacture products. Our associates have been instrumental in the process/ tech transfer of the introduction of new products into manufacturing facilities.
Here at WCJ Quality Consulting LLC, we also assist clients with data analytics. This is beneficial across multiple industries. We mainly assisted clients in the sports sector.