Vice President of Global Quality & Regulatory Affairs
Winston R. Brown works for Phillips – Medisize Corporation, as their Vice President of Global Quality & Regulatory Affairs. Winston has worked in the pharmaceutical, medical device and bio therapeutics industries for 20+ years. Subsequent to serving in the United States Army, he has held positions of increasing responsibility in quality, regulatory, and operations at Johnson & Johnson Consumer Pharmaceuticals, Holopack, USA, Bausch & Lomb, Baxter Healthcare and Alcon, a division of Novartis. Winston earned undergraduate degrees in Microbiology, Operations Management, and Medical Technology. His graduate degrees include an MBA and MS Degree in Pharmaceutical Engineering, and has completed post graduate work at the University of Southern California.
Winston will be one of the distinguished speakers at the 4th Semi-Annual Medical Device Supplier Quality: Efficiency and Collaboration Conference.
Why is the 4th Semi-Annual Medical Device Supplier Quality Conference important for quality executives?
To stay abreast of current industry trends, learn best practices, provide some benchmarking, and to understand how you can potentially get involved in real time industry issues to affect change.
What initiatives are on the horizon for your team in 2016-2017?
The top initiative for Phillips-Medisize Corporation, and others within our industry are: meeting the requirements for the FDA’s Unique Device Identifier (UDI) initiative (including global expectations from regulatory bodies outside of the FDA).
In what ways have you made collaboration with suppliers a reality?
Through virtual sourcing, cost-savings sharing, and other incentivized programs.
What internal departments do you feel are important to be included for holistic/cross-functional supplier quality?
I feel that supplier quality should be an integrated initiative as far upstream in the development process as possible. Key functions that should be part of the supplier decision process (governance) should be: Quality, Operations, Engineering, R&D, Finance, Supply Chain, Legal, and EH&S. Essentially, a governance process that is setup through commodity teams for fast response and triage, but maintained by an overall governing process and committee that is comprised of the functions listed above.
What are some of the benefits you’ve experienced with involving suppliers in early product development stages?
Clear alignment of roles/responsibilities, valuable input into materials science and bio-compatibility with early stage development concepts and prototypes, key input into the design of product stability programs, key input into the overall product dFMEA, pFMEAs and process / product optimization studies, key input into design and tech transfer, and key input into design post-launch loopback into the revisit of the product design.
Does your organization have a PPAP in place? If so, what are some of the challenges and opportunities with a PPAP? At Phillips-Medisize Corporation, some of our facilities are required to establish and sustain PPAP Programs. Some of the challenges include: dealing with differing customer expectations vs. PPAP, re-visiting the Advanced Quality Planning Process, and maintaining sufficient document controls. Key opportunities include: deploying an integrated Quality Management System (QMS) that meets the standard, yet can be harmonized among some of the differing customer expectations.
What is one thing you hope to learn or discuss with your peers at the Supplier Quality Conference?
I hope to interface with others in the industry to keep abreast of current issues, while understanding how the industry views and approaches some of the key challenges we are facing in today’s global marketplace from a supplier quality standpoint. What I hope to provide are my own experiences both from a CMO and Customer perspective, for some of the same issues listed above.