Expert Profile
Betty Lane
Founder and President, Be Quality Associates LLC
Betty Lane has over 30 years’ experience in Medical Device quality assurance and regulatory affairs. She is the founder and President of Be Quality Associates, LLC, a consulting company helping small and medium sized medical device and diagnostic companies implement and improve their quality systems for both FDA and ISO 13485 compliance band business when they became FDA and industry requirements. Her are areas of expertise include training, auditing, supplier management, design controls, software validation and general safety.
Betty’s training experience includes over 25 years of training on all areas ISO 13485 and FDA cGMP, in companies where she worked as manager or director, and for AAMI, ASQ biomedical division, and ASQ sections. She has taught courses in medical quality and regulatory affairs as an Adjunct at Northeastern University, Boston, MA. Betty is active in her local section of the American Society for Quality and is also a member of the RAPS, Association for the Advancement of Medical Instrumentation (AAMI), The Society of Women Engineers and the IEEE. Betty has degrees in engineering from Rensselaer Polytechnic Institute, and an MBA from Northeastern University.
Trainings by Expert
Supplier Evaluation and Internal Auditing for FDA and ISO 13485 Compliance: Pack of Three Courses
Category:
Medical Devices
Creating a Risk-based Supplier Management program
Category:
Medical Devices
,
Audits & Inspections
,
Crisis Management
,
QMS, ISO 13485, CAPA
,
Supply Chain and Manufacturing
,
Supply chain & Procurement
,
Life Sciences
,
Regulatory Affairs
Supplier Quality Agreements - Essential for Suppliers of Many Outsourced Processes
Category:
Medical Devices
,
QMS, ISO 13485, CAPA
,
Supply Chain and Manufacturing
,
Documentation and Policy Management
,
Lifescience process & Procedures
,
Life sciences QA/QC
,
Life Sciences
,
Documentation and Data Management
,
QA/QC
Compliant Supply Chain & Manufacturing for Medical Devices - Comprehensive Training Package (8 Courses)
Category:
Medical Devices
Implementing Robust Supply Chains
Category:
Trade and Logistics Compliance
ISO 14971:2019 - Does your Risk Analysis meet this new revision of the Standard?
Category:
Medical Devices
,
Marketing and Promotion
,
Audits & Inspections
,
QMS, ISO 13485, CAPA
,
Supply Chain and Manufacturing
,
Audit & Inspection-Role
,
Medical Device Inspection
,
Documentation and Policy Management
,
Lifescience process & Procedures
,
Life sciences QA/QC
,
Regulations & Guidances
,
Life Sciences
,
Regulatory Affairs
,
Documentation and Data Management
,
QA/QC
Root Cause Analysis - The Heart of Corrective Action
Category:
Drugs and Chemicals (Pharma)
,
Medical Devices
,
Clinical Research
,
Biotechnology
,
Laboratory Compliance
,
All FDA Regulated Industry
,
GXP Pharmaceutical
,
GXP Medical Devices
,
Quality and Safety
,
QMS, ISO 13485, CAPA
,
Laboratory
,
Quality & Safety
,
Drugs Regulations
,
Clinical Trial Regulations
,
Biotech Regulations
,
Documentation and Policy Management
,
Lifescience process & Procedures
,
Life sciences QA/QC
,
Regulations & Guidances
,
Life Sciences
,
Regulatory Affairs
,
Common FDA Regulations
,
QA/QC
Streamlining your QMS and Audit System for Remote Audits
Category:
Medical Devices
,
Banking and Financial Services
,
Risk Management
,
Corporate Governance
,
Banks and Credit Unions
,
Accounting and Taxation
,
Internal Audit & Control
,
Audit & Inspection-Role
,
Finance, Sox & Internal control
,
Financial Services and Trading
,
Accounting Audits
Medical Device Employee Training - Requirements and Implementation Tips
Category:
Medical Devices
,
HR Compliance
,
QMS, ISO 13485, CAPA
,
Supply Chain and Manufacturing
,
Life sciences QA/QC
,
Life Sciences
,
QA/QC
,
Training
QA Agreements for ISO 13485:2019 and other Regulatory Compliance
Category:
Medical Devices
,
Audits & Inspections
,
QMS, ISO 13485, CAPA
,
Supply Chain and Manufacturing
,
Audit & Inspection-Role
,
Documentation and Policy Management
,
Lifescience process & Procedures
,
Life sciences QA/QC
,
Regulations & Guidances
,
Life Sciences
,
Regulatory Affairs
,
Documentation and Data Management
,
QA/QC
