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Thursday, November 21 • 10:15am - 10:35am
Enabling New Medicines: From Candidate to the Clinic- A Path To Accreditation – Implementing ISO 20387 in a Cornell Biobank

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Biobanks play an integral role in research and precision medicine
by collecting, processing, storing, and distributing high-quality biological material and associated
data. Through the adoption and implementation of standards, biobanks can ensure the integrity,
authenticity, and traceability of their products to enhance reproducibility in research. In
preparation for ISO 20387 (ISO 20387:2018, Biotechnology – Biobanking – General Requirements for
Biobanking) accreditation by the American Association of Laboratory Accreditation (A2LA), the
Cornell Veterinary Biobank (CVB) developed and implemented a quality management system
(QMS) in compliance with this standard, and the information was compiled into a quality
manual. Procedures describing the control of documents and records were implemented first to
provide a foundation on which to build the QMS, followed by procedures for documenting the
identification of risks and opportunities, improvements, and corrective actions following
nonconforming outputs. Internal audit and management review programs, consisting of both
procedures and a schedule, were developed and implemented. Procedures for the governance and
management of the CVB were generated, including: confidentiality and impartiality policies;
facilities and equipment maintenance, calibration and monitoring; staff training and
competency; and evaluation of external providers. All processes on scope were described, along
with the validation and verification of methods to ensure its reproducibility, robustness, and the
fitness-for-purpose of the biological material and data produced. Training sessions were held during implementation to ensure all staff were familiar and would conform to the procedures. In
April of 2019 the CVB was assessed by A2LA for compliance with ISO 20387, and became the
first biobank to receive accreditation to this standard.

avatar for Marta Castelhano

Marta Castelhano

Cornell Biobank Director, Cornell University
Dr Castelhano is the Director of the Cornell Veterinary Biobank (CVB) and has 13 years of experience in biobanking, particularly in the standardized collection, processing, storage, and distribution of high-quality biospecimens and associated data. She has been a member of the Education... Read More →


Rose Gonzales

Director, Pfizer

Thursday November 21, 2019 10:15am - 10:35am EST
Essex South (3rd Floor) - Westin Copley 10 Huntington Avenue, Boston, MA 02116 USA

Attendees (1)