Managing the Computerized System Validation Workload

On 10th September 2020 Thursday 11:00 AM EST

Watch Recording

This webinar discusses Managing the Computerised System Validation (CSV) workload

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.

Speaker Introduction

Dr. Siegfried Schmitt

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.

Discussion panel

Timur Kabadayi,

Managing Director, CONVALgroup

Banu Refik,

Senior Consultant Quality, CONVALgroup

Arjun Guha,

Director Operations, CONVALgroup

What will you take away from the session?

  • An insight into CSV - Back to Basics
  • The risk-based approach - How to arrive at an Action Priority Rating
  • Preparing the CSV plan and planning