Expert Profile
Lena Cordie Bancroft
President, 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 and 11 years as director of operations at Key Surgical, a medical device company focused on sterile processing, personal protection, and OR products. In this position she was responsible for overseeing all quality and regulatory functions, production, product procurement, and order fulfillment.
As a consultant at Qualitas Professional Services, LLC, Ms. Cordie now focuses on helping companies implement quality management systems, UDI solutions for labelling and FDA GUDID submissions, and providing validation, documentation and project management resources to global medical device companies.
She 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 terminology committee; ISO (International Organization for Standardization) – serves as a US representative and participates in ISO/TC 198 (ISO 17664 & ISO 11139) and ISO/TC 210 (ISO 13485 & ISO 15223) working groups; and RAPS (Regulatory Affairs Professionals Society) – serving as chairperson of the RAPS Twin Cities Chapter.
Trainings by Expert
Preparing for a UDI Implementation
Category:
Medical Devices
,
Packaging and Labeling
,
All FDA Regulated Industry
,
GXP Medical Devices
,
Marketing and Promotion
,
Quality and Safety
,
Supply Chain and Manufacturing
,
Life sciences QA/QC
,
Regulations & Guidances
,
Life Sciences
,
Regulatory Affairs
,
Common FDA Regulations
,
QA/QC
Standards and Their Role in Medical Device and Patient Safety
Category:
Medical Devices
,
All FDA Regulated Industry
,
GXP Medical Devices
,
Marketing and Promotion
,
Quality and Safety
,
QMS, ISO 13485, CAPA
,
Supply Chain and Manufacturing
,
Regulations & Guidances
,
Life Sciences
,
Regulatory Affairs
Overview of Changes in ISO 13485: 2016
Category:
Medical Devices
,
All FDA Regulated Industry
,
GXP Medical Devices
,
Quality and Safety
,
QMS, ISO 13485, CAPA
,
Supply Chain and Manufacturing
,
Life sciences QA/QC
,
Supply chain & Procurement
,
Regulations & Guidances
,
Life Sciences
,
Regulatory Affairs
,
Common FDA Regulations
,
QA/QC
