Welcome to Aura!
Aura is a company specialized in making the perfect connection between people and projects.
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About
ABOUT
Aura is a company specialized in making the perfect connection between people and projects.
Our team is specialized in quality and regulatory compliance consulting in food, pharmaceutical and cosmetic industries.
Our consultants are always up-to-date with professional knowledge, expertise, legislation, best practices, GMP, GxP, and other regulations.
These specifications ensure that projects by Aura will be handled accurately and successfully.
Team
OUR TEAM
Leonie Vangansbeke
Leonie is a Regulatory Compliance/ Quality Assurance consultant with strong technical skills, fast learning capabilities and a problem-solving mindset. Possesses strong analytical capabilities and excellent communication skills. She has the ability to work quickly and accurately, take initiative, when required.
Is an ideal team-member due to her working spirit, sense for initiative and friendliness. Is always up-to-date with professional knowledge, expertise, legislation, best practices, excellent knowledge in GxP requirements and other regulations.
Has a proven ability to engage constructively with colleagues at all levels across different departments to deliver objectives.
These specifications ensure that projects by Aurélia will be handled accurately and successfully.
Expertise
- Medical devices
- Combination products
- In-vitro diagnostics
- Pharma
- Food
- Cosmetics
- Quality Risk Management
- Regulatory Compliance
- Training
- Validation and Qualification
- Project Management
Certificates
- Prince 2 Foundation
- Internal auditor ISO 9001 : 2015
- Internal auditor ISO 13485 : 2016
- Supplier auditor
Helene Symens
Hélène is our senior Quality Assurance consultant who is specialized in revamping Quality Management Systems. She is an ideal team member, has a good working spirit, and will handle projects in a correct and pragmatic manner.
Expertise
- Medical devices
- ISO 13485
- 21 CFR 820, 803, 806
- Training
- CE marking
- CAPA processes
- Complaint processes
- ESH Management
- Validation
- Quality Assurance
Certificates
- CESS and qualification certificate
- ISO 9001 and 13485
Blog
Case Study: Mobile Medical Apps or mHealth Apps, do they have to follow medical device regulations (FDA/EU) or not?
Mobile Medical Applications There has been a rapid development of mobile health apps or mHealth apps in the last few years. The rapid increase has caught the eye of regulatory institutes worldwide. Valid resources of information regarding related legislative issues are available, despite it is not easy for application developers to interpret the specific laws, directives, …
Failure Mode and Effect Analysis – FMEA
DISCLAIMER: This blog post solely represents my own opinion based on experience and/or interpretations. As a former Subject Matter Expert Quality Risk Management and trainer in one of the pharmaceutical big 5 companies I have extensive experience in performing and guiding failure mode and effect analyses. EPISODE – 1 In this series I will give …
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