Sr. Consultant, Quality & Best Practices Unit
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.
Head of the Quality & Best Practices Unit
Brian Graeff is currently the President of Brian Graeff LLC, an independent consulting company providing Quality Systems and GMP consulting services to the pharmaceutical industry. Brian retired from Sunovion Pharmaceuticals Inc. in December 2010, after serving as the VP of Quality Operations for 5 years.
Brian’s career in the pharmaceutical industry spans over 39 years. He held various management positions in Quality Assurance, Quality Control and Production with Sterling Drug – Winthrop Laboratories, AstraZeneca and Sunovion. During those years, Brian helped manage many different drug products and API with the majority of his experience being with parenteral, respiratory and tablet dosage forms.
Brian brings a wealth of experience in pharmaceutical manufacturing, quality management, United States Food & Drug Administration (FDA) interactions and CGMP interpretation and implementation to SOLABS. He believes that “Focusing on the Fundamentals” is the key to product quality, compliance and maintaining a company’s license to operate.
Sr. Consultant, Quality & Best Practices Unit
John Carkner has had a career spanning more than 35 years in the pharmaceutical industry. A microbiologist by training, he began his career in Quality Control with Pfizer Canada. John gradually took on more responsibility, including overall Quality for Pfizer’s Canadian manufacturing operations, eventually became Site Leader of their Arnprior, Ontario manufacturing site.
When Pfizer divested the Arnprior site in 2009, John began a new phase of his career leading a contract manufacturing organization. He concluded his career as President and CEO of Pillar5 Pharma Inc., and after five years in contract manufacturing, moved to a less structured role as a consultant to the industry.
John serves as Chairman of the Board of M. Sullivan & Sons Ltd., a privately owned construction firm in Eastern Ontario. He has also held many volunteer roles, and presently serves as a Director of Community Living Renfrew County South, an organization that works to improve the quality of life for people with developmental disabilities.
John has recently joined the Quality Best Practices Unit of SOLABS as a Senior Consultant. His main area of interest with SOLABS is the strategic use of information technology to optimize operational efficiency and create value in quality practices.
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.
October 26, 2016: Creating & Sustaining a Quality Culture: Part 2 – Making an Impact by John Carkner
October 5, 2016: Creating & Sustaining a Quality Culture: Part 1 – Living the Values by John Carkner
September 21, 2016: Creating & Sustaining a Quality Culture: Introduction by John Carkner
September 9, 2016: 5 Tips for Communicating with FDA Auditors by John Carkner
August 24, 2016: Preparing for an Audit by John Carkner
July 13, 2016: Handling Customer Product Complaints by Brian Graeff
Apr. 27, 2016: Does Your CAPA Process Need a CAPA? by Brian Graeff
Feb. 10, 2016: The Right EQMS: The Best Investment You’ll Make This Year by John Carkner
Feb. 3, 2016: EQMS Software Evaluation & Selection Guide for the Life Sciences by Brian Graeff
Dec. 16, 2015: EQMS Implementation & Use in the Clinical Trials Industry: Part 6 – Wrap-up by Nathalie Bourgouin
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.