How to Comply with the New Revision of USP 1058 under a Lockdown, Upcoming Webinar Hosted by Xtalks

Share Article

In this free webinar, the featured speakers will discuss the changes made to USP 1058 in 2017 and its impact on the analytical instrument qualification lifecycle. Attendees will learn about viable solutions for instrument maintenance/qualification during a lockdown.

Xtalks Life Science Webinars

Changes in the 2017 revision of <1058> require descriptive risk assessment, documented user requirements, and strong performance qualification (PQ) plans.

Analytical laboratories required to demonstrate the suitability of their equipment will generally follow USP Chapter 1058 on analytical instrument qualifications (AIQ). This chapter was first introduced in 2008 and remained unchanged for nine years, but it was updated on two separate occasions in 2017. Although the 2008 and 2017 versions of USP 1058 appear similar on first read, deeper analysis reveals the significance of the regulatory changes and their impact on laboratory compliance requirements. Changes in the 2017 revision of 1058 require descriptive risk assessment, documented user requirements, and strong performance qualification (PQ) plans.

Many laboratories are unsure how to be compliant with the 2017 changes to USP 1058. Those that have not addressed these changes will find it increasingly difficult to respond to the present lockdown environment. These rapidly changing work conditions make traditional laboratory services more difficult to provide in light of restrictive government and corporate policies. Services such as repairs, maintenance, calibrations, and qualifications may be delayed, prompting laboratories to use alternative and/or expired equipment. Although these alternatives are not preferred, the principles behind this approach are supported by regulatory statements, provided these alternatives are backed through meaningful risk assessment. As well as explaining the significance of the 2017 1058 changes, this webinar will suggest strategies for remaining compliant under a lockdown.

Join Matt Abrahms, Americas Compliance Application Expert, Agilent and Paul Smith, Global Compliance Specialist, Agilent in a live webinar on Wednesday, July 15, 2020 at 12pm EDT (5pm BST/UK).

For more information or to register for this event, visit How to Comply with the New Revision of USP 1058 under a Lockdown.

ABOUT XTALKS

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit http://xtalks.com
For information about hosting a webinar visit http://xtalks.com/why-host-a-webinar/

Share article on social media or email:

View article via:

Pdf Print

Contact Author

Sydney Perelmutter
Xtalks
+1 (416) 977-6555 x 352
Email >
Visit website