Renata E. Skros CGI

Renata has been working in the Pharmaceutical Industry since 2000, with experience ranging in Quality Control Microbiology, Quality Systems, and Regulatory Affairs. I have extensive knowledge of both Commercial (sterile and non-sterile) and Research & Development. She specializes in Good Laboratory Practices, Good Manufacturing Practices, Supply Chain Management, Deviation writing, review and processing, CAPA and Effectiveness Check Management, Complaints, Annual Product Review, SOP Document Management, Change Controls & Planned Deviations, Performing Gap Analysis on Quality Control and Quality Systems procedures. Renata has overseen a number of continuous improvements projects such as; Assisting in the Development of Archival procedures for Logbooks, Introduction of Forms into the Document Management System, and Improving the quality of writing deviations. She greatly enjoys investigating Major and Critical Events, and seeing that the associated corrective and preventive actions were effective. I have assisted in the development of a RCA & CAPA/EC Planning methodology to deploy best practices into an organization and support their learning in this area using proactive risk management skills; while performing robust investigations and proper root cause analysis techniques. Additionally, I have authored two (2) white papers and have a podcast coming out on best practices and proactive CAPA management skills.