Our independent Quality and Best Practices Unit is responsible for defining and benchmarking our standards, making sure they align with industry standards and best practices, and ensuring SOLABS’ clients receive the highest levels of recognition for their QA practices.
Founder & CEO
As CEO of SOLABS, and almost 18 years after co-founding the company, Philippe Gaudreau continues to grow an avid interest in quality management and compliance practices in the Life Sciences.
He is passionate about finding best in class solutions, with the goal of helping our Life Sciences clients automate their quality operations without losing the flexibility they have with their manual systems.
He offers his expertise through his devotion to software development, his deep knowledge of business process management and optimization, and his expertise in document life cycle management.
Gretchen Dixson is a Compliance & Quality Systems professional experienced in the administration of electronic documentation and learning management systems in a regulated manufacturing environment.
Gretchen brings over 36 years of experience in the pharmaceutical industry including various management positions in Quality Assurance and Quality Control. She retired from AstraZeneca in October 2016 after 28 years.
Her experience in Documentation Systems includes Master Production Records, SOPs, Specifications, Stability Protocols, Training Materials, Annual Product Reviews and CMC Sections for FDA Submissions. Her experience in Training Systems includes delivery of site-wide training on various GMP topics, system administration of the site Learning Management Systems and project management for system upgrades and migrations.
With over 25 years of experience in Pharmaceuticals and Biotech in North America, Nathalie Bourgouin is a leader in Compliance, Quality and Project Management with a solid background in risk-based clinical/quality assurance processes, training and auditing. She has planned and audited numerous sites and vendors as part of several global studies.
At Skillpad, Nathalie leads the Compliance Consulting group with a focus on Clinical Trials and Research compliance. She is the content expert of the new Premium Suite of Clinical Inspection Readiness e-Lessons supporting sponsors. She has supported clients on a variety of projects: preparation of training material, development of critical SOPs for clinical trials, preparation and performance of clinical audits, inspection readiness coaching, quality and regulatory interim services, and project management.
Aug. 2, 2017: Who Says Automating Quality Operations Isn’t Sexy? by Philippe Gaudreau
Jun. 16, 2017: Top 10 Quality & Best Practices Blogs of the Last Year by SOLABS
May 31, 2017: Lean Manufacturing and Quality by John Carkner
Apr. 26, 2017: Issue Escalation: 5 Tips for Communicating with Senior Management by John Carkner
Mar. 22, 2017: Quality and Safety Have A Lot in Common by John Carkner
Feb. 1, 2017: FDA Contract Manufacturing Guidance and EQMS by John Carkner
Jan. 4, 2017: Product Documentation: Essential to an Effective Quality Program by John Carkner
Nov. 9, 2016: Creating & Sustaining a Quality Culture: Part 3 – Internal & External Messaging by John Carkner
Oct. 26, 2016: Creating & Sustaining a Quality Culture: Part 2 – Making an Impact by John Carkner
Oct. 5, 2016: Creating & Sustaining a Quality Culture: Part 1 – Living the Values by John Carkner
This group works very closely with our R&D and Professional Services groups. It is responsible for defining standards in best practices, and for allowing clients to implement off-the-shelf quality process APPS in order to reduce implementation time and validation efforts.See our SOLABS QM APPS
The best practices unit is also responsible for content generation and circulation on such diverse topics as the transition from paper-based QMS to EQMS, Deviations Management, and for hosting presentations and webinars on industry-centric topics such as Non-Conformance Management.Presentation on Non-Conformance Management
First and Foremost: Quality Assurance
Primarily, our QA Group is dedicated to ensuring that our internal and external practices are in line with those of our clients. We also implement compliance through SOLABS QM, and with stringent rules and guidelines in mind, as issued by regulatory and standardizing bodies across the world: FDA, Health Canada, EMA, PMAD, PIC/S, etc.
Challenge design and functional specifications through continuous feedback and test loops.
Provide documentation to support the continuous validated state of SOLABS QM, its applications and interfaces for each of our clients.
Maintain and define our internal quality system based on ISO requirements.