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
¡Todo sobre los ensayos de validaciones para cumplir con los máximos estándares regulatorios!
Hablaremos sobre puntos cruciales de los servicios de validación, incluyendo:
1. Necesidad de validación
2. Cómo se realizan los ensayos de validación
3. Análisis de riesgo: re uso de filtros y toma de decisión en ensayos a realizar
4. Servicio de Validación Pall: documentación requerida para iniciar una cotización
¡No pierdas esta segunda oportunidad!