The increased deployment of automated systems in the pharmaceutical industry means the Computerised Systems Validation (CSV) effort is also increasing. As resources are always limited, it is important to manage them efficiently and effectively.
It is easy to get lost in the data, the information, the risk assessments. Therefore, a proven, sensible, and logical approach that also satisfies the regulators is required.
Dr. Schmitt will primarily focus upon the same during the webinar and provide guidance for managing CSV in more comfortable manner without any confusion and ambiguity.
Siegfried provides consulting services to the regulated healthcare industry on all aspects of regulatory compliance, particularly the design and implementation of Quality Management Systems and Competitive Compliance.
Siegfried holds the position of Vice President Technical at PAREXEL Consulting. His areas of expertise include all aspects of quality and compliance for systems, processes, facilities, and operations for drug substances and drug products, for all types of formulations.
Siegfried is a seasoned and experienced auditor, providing support to clients pre and post inspections or audits. Siegfried has previously held positions in industry as Senior Production Chemist with Roche and global Quality Director with GE Healthcare and as Validation Manager with Raytheon and Senior Lead Consultant with ABB.As an active member of various industry associations, Siegfried is a frequent presenter and committee member of international events. He is also an accomplished author and editor as well as member or chairman of several editorial boards. Siegfried is a Chemist by background and holds Chartered Chemist and Chartered Scientist status.
Managing Director, CONVALgroup
Senior Consultant Quality, CONVALgroup
Director Operations, CONVALgroup