Data Integrity Requirements For Filter Integrity Test Instruments

 

Data integrity is the extent to which all data are complete, consistent and accurate throughout the data lifecycle. It is fundamental in a pharmaceutical quality system which ensures that medicines are of the required quality.

Data integrity arrangements must ensure that the accuracy, completeness, content and meaning of data is retained throughout the data lifecycle. Data integrity is critical throughout the CGMP data life cycle, including in the creation, modification, processing, maintenance, archival, retrieval, transmission, and data disposal after the record’s retention period ends. System design and controls should enable easy detection of errors, omissions, and unexpected results throughout the data’s life cycle.

In this webinar, data integrity requirements for filter integrity test instruments will be discussed and demonstrated, with specific focus on: static electronic record, electronic audit trail of relevant GMP parameters, access control, data backup and data transfer.

 

Speakers

Dr. Razan Jammal

 

Global Product Manager Instrumentation

Pall

 

Dr. Razan Jammal joined Pall in January 2020 to manage the filter integrity and leak test instruments portfolio. Previously, she worked as EMEA product marketing manager for instrumentation and clinical application technology in the IVD market. Razan has a Masters’ degree in Genetic engineering and holds a PhD degree in Oncology from Hannover Medical School.

Dr. Joerg Schubert

 

Scientific Laboratory Services Director

Pall

 

Dr. Joerg Schubert has more than 24 years of combined experience in technical support, process optimization, filter validation and R&D. He has an extensive experience with DSP applications including direct flow filtration technology (sterile, depth & virus filtration), comprehensive expertise in single-use systems and over 20 years of experience in filter integrity testing in the pharmaceutical and biotech industry. Joerg Schubert has a Masters’ degree in Chemistry, and hold a PhD degree in Technical Chemistry from the Leibniz University Hanover.

Data Integrity Requirements For Filter Integrity Test Instruments

Enhance the data protection of your filter integrity test device

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Getting Ready for SUT X-Ray Irradiation

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Why the introduction of X-ray sterilization technology is a critical change for single-use industry, and how gamma and X-ray irradiation compare

 

The market demand for gamma irradiation, the current primary method for the sterilization in SUT, will soon significantly exceed supply, creating an urgent need for alternatives.

 

Join Christelle Marcoux from GSK Vaccines (BioPhorum workstream member on alternatives to gamma sterilization) and James Hathcock, PhD of Pall Corporation (Bio-Process Systems Alliance X-Ray Committee Co-Chair) as they discuss the introduction of X-ray sterilization technology.

 

You will learn more about:

 

  • Why this is a critical change for industry and the responsibilities of each stakeholder
  • Key questions to address for biomanufacturers
  • How gamma and X-ray irradiation compare
  • What testing has been completed and key milestones for readiness for industry
  • An example of how to qualify a SUS sterilized with X-ray irradiation
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