webinar

Data integrity and digital workflow guidance in a contemporary pharma lab

Supported by:

13 April 2021

3:00pm

Supported by:

13 April 2021

3:00pm

ABOUT THIS WEBINAR

Correct data is fundamental in a GxP quality system. In this webinar we will discuss what needs to be put in place to ensure data integrity and minimise the risk for your organisation. We will discuss how to achieve data integrity and give real examples from the US Food and Drug Administration (FDA) warning letters about the most frequent and typical violations. To prevent violations, processes and systems should be designed to follow the ALCOA principles, which will be explained in detail.

We will also review how a modern lab instrument can provide all the technical features that are needed to automate processes and which ensure that data integrity compliance issues are not created. As an example, we will guide you through the functionalities of Cubis II, the second generation premium laboratory balance portfolio from Sartorius. In addition, we will discuss software applications (QApps) for QC- or production-relevant applications like tablet and vial checker (uniformity of dosage, USP chapter <905>), loss on drying (USP chapter <731>), standard preparation (USP chapter <129>), pharma filling (transfer of liquid products) or MYCAP CCX (transfer of media and inoculum). The software applications safely guide operators through the workflow, automatically calculate the results and have conformity checks included.

Cubis II is the only laboratory scale available on the market that offers full pharma compliance and state of the art digital workflow support without a need for any additional software.

Key learning outcomes:

  • The importance of data integrity
  • How to ensure data integrity and minimise the risk for your organisation
  • How a laboratory balance can support full pharma compliance without a need for additional software
  • How software applications with guided workflows help to achieve trustable and compliant results.

Register

Register to watch this live webinar
















    Unless making a secure payment with your credit or debit card via a third-party payment processor, this form is not designed to collect confidential or sensitive personal information (e.g., financial information, social security numbers).

    *Required field

    Your details


    *


    *

    *

    *


    *

    Other information

    Email preferences

    If you’re not already opted-in to receive our emails, please select which types of communication you would like to receive:


    Confirm that you're human

    By clicking register, you consent to European Pharmaceutical Review contacting you about this and future webinars, and that you agree to our terms and conditions and privacy policy. Your information will be processed in accordance with GDPR and you can unsubscribe at any time.

    Speakers

    Dr Eszter PaldyDr Eszter Paldy, Product Manager Premium Weighing Solutions, Sartorius

    Eszter studied biology at the University of Szeged in Hungary and earned her PhD in Pharmacology. Following her PhD, she was awarded with the Humboldt Fellowship for postdoctoral researchers and worked at the Pharmacology Institute of the Medical University in Heidelberg in Germany. During this time, she has further educated herself in business, project and product management. She joined Sartorius in 2017 where she works as a product manager for premium weighing solutions and is actively involved in new projects for product development.

    Dr Holger DensowDr Holger Densow, Product Manager Premium Software Applications, Sartorius

    Holger studied biology at the University of Bielefeld in Germany and finished his Doctorate in 2005. He then worked as a sales representative for two and a half years for a German biotech company. In 2008 he joined another company to manage lab instruments as a product manager. Since 2016 he has worked as a product manager at Sartorius and is taking care of software solutions for lab balances.

    Send this to a friend