The RAPS UK Local Networking Group (UK LNG) is offering a series of complimentary webinars as part of its 2021 post-COVID Relaunch. You are invited to the last of three virtual events on the "2021 Recap and What to Expect in 2022".
Learning Level
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Who Should Attend?
RAPS UK LNG members and others
Speaker(s)
Lena Cordie-Bancroft, President/Principal Consultant, Qualitas Professional Services, LLC
Lena Cordie has over 20 years of quality and project management experience including:
- 10 years in project management at Target Financial Services
- 11 years as Direct of Operations at Key Surgical
- 4+ years as President, Consultant at Qualitas Professional Services. As a consultant at Qualitas Professional Services, LLC, Ms. Cordie now focuses on training and helping companies implement quality management systems, UDI solutions for labelling and GUDID submissions, and providing internal audit, validation, documentation and project management resources to medical device companies.
Lena is an active member of:
- AAMI (Association for the Advancement of Medical Instrumentation) – serves as a voting member of many sterilization standards committees and co-chairs the AAMI ST/WG 5 - Terminology committee
- ISO (International Organization for Standardization) – serves as a US expert on the following committees: o ISO/TC 198 WG 5 – Terminology o ISO/TC 198 WG 11 - General criteria for sterilization processes and sterilizing equipment o ISO/TC 198 WG 12 – Information for reprocessing of resterilizable devices o ISO/TC 210 WG 1 – Application of quality systems to medical devices o ISO/TC 210 WG 2 – General aspects stemming from the application of quality principles to medical devices o ISO/TC 210 WG 3 – Symbols and nomenclature for medical devices
- RAPS (Regulatory Affairs Professionals Society) – serving as chairperson of the RAPS Twin Cities Chapter and as a member of the RAPS European Council (REC) • Member of ASQ (American Society for Quality).
Rina Nir, CEO, RadBee Ltd
Rina is the CEO of RadBee Ltd, an Atlassian Solution Partner that specialises in helping clients in the life sciences sector with compliance issues related to the implementation of Atlassian tools. She regularly delivers projects within strict validation frameworks, using the Atlassian tools to expedite and optimise the process. Prior to starting RadBee, Rina co-founded a medical devices company and lead its R&D, operations and HR functions. In this role she was involved in the implementation of an ISO 13485 quality system and making submissions to the regulatory authorities in Europe and the United States. This gave her firsthand experience of the challenges of balancing innovation and compliance in life sciences operations and how JIRA can help. She went on to establish RadBee, inspired by her conviction about the key role Atlassian tools can play in modernising R&D and quality processes. Rina regularly writes and presents about issues related to compliance and how JIRA and Confluence can help.
Gert Bos, Executive Director & Partner, Qserve
Gert has 26 years of experience in life sciences (devices and pharma), in university, industry, 4 Notified Bodies, and in strategic regulatory and business consulting.
He is a president-elect and member of the Board of Directors of RAPS, founding member of the Board of Directors of RAPS Europe and a founding board member of the Dutch RAPS Chapter.
Gert provides strategic consulting on complex regulatory matters, on interactions with Notified Bodies and EU pharma agencies, on suspensions and cancellations of certificates, field safety corrective actions and more. He is supporting due diligence processes from RA/QA perspective. And finally, he provides insightful dedicated in-house training on regulatory matters, including EU-MDR and EU-IVDR.
Before joining Qserve, he served 7 years as Head of Regulatory and Clinical Affairs of BSI (NB0086) and Head of Notified Body at BSI-Germany (NB0535), and a similar time as head of the certification team at KEMA (now Dekra, NB0344).
He has served as President of the Notified Body Association TEAM-NB, and as Chair and Vice-Chair of the Medical Notified Body forum NB-Med in Brussels for over a decade. In these roles, he represented Notified Bodies in many EU Commission meetings and workgroups and represented Notified Bodies in the process of drafting and finalizing the EU-MDR.
Susana De Azevedo Waesch, Vice President Quality Management & Regulatory Affairs, Ypsomed AG
TBC, TUV SUD