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 Biotech
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 Biotech
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
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Biotech | Pall Corporation webinar series
From October 20th to November 19th
There is no single vaccine manufacturing approach. There are, however, flexible technologies that can meet each of the challenges during process development and at GMP scale.
Accelerating vaccine development and manufacturing by coupling research advances in vaccine technology with systems that support agility through a Quality by Design approach is critical to deliver life-saving immunizations to those in need globally.
Diversity in the type of vaccine antigen, along with the inherent variation in the targets, have created challenges for vaccine manufacturers when compared to a relatively small number of platform processes that exist.
There are flexible technologies that can meet each of the challenges during PD and at GMP scale.
Join this webinar series and learn more about securing process quality with flexible manufacturing solutions.
Webinars available
- Vaccines development, regulations and manufacturing Parts 1 & 2
- Developing scalable upstream workflows for recombinant and viral vaccine processes
- Downstream process development for vaccine manufacturing
- Implementing single-use technologies in formulation and filling of vaccines