SOURCE: Xtalks

Xtalks Webinars

May 05, 2016 07:00 ET

Mitigate the Risk of Receiving FDA 483 Observations -- Your Guide to a Preventative Approach, New Webinar Hosted by Xtalks

TORONTO, ON--(Marketwired - May 05, 2016) - On Tuesday, May 24, 2016, a panel of FDA and manufacturing execution system (MES) experts including speakers from LZ Lifescience and Robert Lewis, FDA consultant, IHL Consulting Group will give a live presentation aiming to help life science companies reduce the risk of getting FDA 483 in 2016 and beyond.

Key Takeaway Points

  • Hear common inspection observations from the FDA and key reasons for form 483 and warning letters
  • Learn how to best handle FDA warnings with the appropriate corrective response
  • Understand MES technology and how it can work as a preventative approach
  • Gain tips and techniques to improve manufacturing performance by over 25%

Life science companies can reduce the stress of compliance audits and minimize the risk of receiving FDA 483s through utilizing a more informed and preventative approach to operations management.

FDA Update 2016 / 2017

The FDA is responsible for issuing 483 observations to life science companies if during audits they find any violations, production or quality issues that raise concern to the health or safety of the general public. More and more life science companies are being issued with FDA 483s, sometimes with catastrophic outcomes. When it comes to avoiding these letters, an understanding of industry requirements, using appropriate tools and preparing for audits is key.

In this webinar the panelists ask the FDA:

  • What is an FDA 483 observation and warning letter?
  • What is the FDA typically looking for during an audit?
  • How likely is your company to receive an FDA 483 and what are the most common reasons for letters being issued?
  • What should companies do if they receive an FDA 483?
  • What are the top tips for responding to warning letters -- with guidance on what to do and what not to do.
  • What can companies do to prevent receiving an FDA form 483 or warning letter?

Corrective and Preventative Action

Archaic systems can be a leading cause of contamination and data integrity issues, and so, now more than ever, organizations need to embrace technology as a preventative approach to these issues.

The webinar will also cover how life science companies can proactively use the latest technology advancement for corrective and preventative actions (CAPA) to help overcome challenges such as data integrity issues, human error and workflow issues.

Introducing electronic batch records / device history records

Find out how batch records can prevent incomplete data and contamination issues and discover how Shopfloor-Online™ Lifescience Edition, a robust and reliable MES solution designed for life science companies, can improve manufacturing performance and drive operational excellence.

For more information or to register for this free webinar visit: Mitigate the Risk of Receiving FDA 483 Observations - Your Guide to a Preventative Approach

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech 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/sponsorship.ashx

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