HYBRID EVENT: You can participate in person at Rome, Italy or Virtually from your home or work.

4th Edition of International Conference on Tissue Engineering and Regenerative Medicine

September 19-21 | Rome, Italy

September 19 -21, 2024 | Rome, Italy
TERMC 2021

Patrycja Sitek

Patrycja Sitek, Speaker at Tissue Engineering Conferences
Wroclaw Medical University, Poland
Title : Adapting to new COVID-19 reality in polish biobanking network BBMRI.pl - QMS system implementation, audits and trainings

Abstract:

1. COVID-19 pandemic has a strong impact for functioning of biobanks across the world. Severe restrictions implemented by national and international administrative organs and changes in policies of human biological material in biobanking entities, influenced the way of auditing, training and implementing the Quality Management Systems (QMS) in Polish Biobanking Network.

2. The BBMRI.pl QMS team has made a risk analysis and suggested actions to stay active in the pandemic. In the field of auditing, the BBMRI.pl QMS experts team have developed and implemented a set of procedures for effective remote audits conducting. Technological solutions such as software-based platforms and personal cloud storage enable exchanging  documents or data and offer communication in real time. It results to perform audits completely or partially remotely. The exchange of information took place objectively and was correctly received.

3. The new COVID-19 reality also influenced the implementation of QMS in biobanks as well as training and improvement. BBMRI.pl QMS experts managed with the situation by developing a proprietary training system in the form of online webinars and offering to the members and observers of the Polish Biobanking Network, the possibility of continuous consulting as a part of the creation and implementation of  QMS SOPs. Each biobank has also received a dedicated QMS consultant responsible for Biobank improvement.

4. All of the actions and tools, used during pandemic, allowed for the continuation of the development process of the Polish Biobanking Network, including audits for compliance with Quality Standards for Polish Biobanks as well as training and consultations. Thanks to this, the continuation of biobank`s improvement , as well as BBMRI.pl project, is possible. Also the expectations both side were fulfilled.

Biography:

Patrycja Sitek QMS Coordinator and Lead ISO 9001:2015 auditor in BBMRI.pl project, MSC in biotechnology and chemistry, ongoing PhD in Chemistry, 3 years’ experience in bio banking, 12 years’ experience in pharmacy and medical devices, CRK owner, TUV Nord trainer

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