Ensuring system quality to deliver easier audits

Quality is imperative throughout the entire development, validation, and final release testing of any therapeutic product. Often involving many complex and multifaceted challenges, vendors have a responsibility to ensure that their products meet defined criteria to deliver reliability and peace of mind to the end user.

In this online seminar series, software specialists will discuss how a modern chromatography data system (CDS) can provide a secure software platform from its early design, offering all the tools you need to maintain the integrity of your data, while alleviating concerns associated with regulatory audits.

If you would like to attend a webinar but are unable to join live, please do still register as all registrants will receive an on-demand link which you can use to watch the webinar after the live date.

Webinar 3. Ensuring system quality to deliver easier audits

• Find out how you can prepare for an inevitable audit
• Learn about current regulatory requirements and what this means for your lab
• Discover expert hints and tips for an effective system review

Presenter: Patrick Kenny (Software Compliance Product Manager, Thermo Fisher Scientific)

Patrick Kenny holds BS and MS degrees in chemistry from the University of Massachusetts Dartmouth and University of Massachusetts Amherst. Kenny spent 13 years in management and director roles in pharmaceutical laboratories. In these roles, he represented the chemistry lab in FDA, EMA, ISO, QP and customer audits. Kenny’s extensive regulated-lab management experience gives him a unique insight into the challenges lab managers face on a daily basis. He uses this knowledge to help customers best utilize their software to achieve regulatory compliance while realizing high productivity.