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Career Catalyst | Retiring the V-Model: Smarter, Faster, Risk-Based C&Q for Modern Pharma
If your C&Q approach still looks like a classic 90s V-Model —stacked IQ/OQ binders, duplicated testing, and “qualification for comfort” — this session is your permission slip to retire it. We’re talking about how pharma manufacturing teams can shift to a modern, regulator-aligned, risk-based commissioning and qualification approach that’s faster, leaner, and more defensible — because it ties verification directly to what actually matters: patient safety, product quality, and data integrity. You’ll hear how Quality Risk Management (QRM) changes the game through System Risk Assessments, clearer criticality, and smarter use of engineering evidence — so you can cut the noise, keep compliance strong, and get facilities started up and inspection-ready without the drag.
Key Takeaways:
How to move beyond "testing twice" to "testing once" based on establishing a risk-based strategy per ISPE Commissioning and Qualification Baseline Guide 5 Vol 2.
How to use commissioning/GEP deliverables as real evidence for qualification testing based on the risk-based testing strategy.
A practical implementation path: rethink system boundaries/classification, develop system risk assessments early, define CQAs/CPPs early and critical design elements to mitigate risks to CPPs/CQAs, and review a case study of the risk-based approach on an actual project.
Who Should Attend
CQV Engineers & Specialists
Validation Engineers (CSV/Process/Equipment)
Anyone actively executing or managing IQ/OQ/PQ
Anyone interested in learning more about CQV
About the Host
Kayla Britt, M.S.
Published scientist and former cell-therapy validation engineer (Kite/Gilead) turned AI validation specialist. I translate context-of-use into acceptance criteria, URS/VP, executed evidence packs, and change-controlled releases—so R&D assistants and GxP-adjacent workflows are not just accurate, but audit-defensible.
About the Speaker
Stephanie White
Stephanie is a pharmaceutical and biotech manufacturing leader with 23+ years of experience delivering CQV and operational readiness for sterile manufacturing and capital programs. As CQV and Operational Readiness Lead at A-Bio, she builds practical, risk-based strategies that connect commissioning and qualification to how teams actually start up, run, and stay inspection-ready. Her background spans engineering and validation leadership across CRB, Pfizer, Baxter/Baxalta/Shire, Takeda, and Amgen, and most recently Global Validation Director at Emergent BioSolutions, where she led global governance and supported digital modernization to improve speed and consistency. She’s recognized for scaling programs that stick—standardizing global CQV by implementing QRM based on ICH Q9 and ISPE C&Q Baseline Guide 5. Stephanie is an active ISPE contributor to Good Engineering Practices and Digital Validation guidance and serves in 2026 as Chair of the ISPE C&Q Steering Committee Community of Practice. She holds master’s degrees in engineering management and biomedical quality systems and bachelor’s degrees in electrical engineering and education.
About the Program
Career Catalyst
Career Catalyst is BioBuzz’s flagship weekly virtual series connecting life sciences professionals with experts and actionable insights. The program runs every Tuesday @ 12 PM EST for approximately 45 minutes:
20-minute expert presentation
25-minute live, open Q&A
Sessions rotate through four thematic tracks with new experts each week, ensuring content stays relevant for life sciences professionals at every career stage. Each track is community-led and hosted by our Career Community Ambassadors.
Tracks include:
➡️ Career Navigation — Networking, skill-building, and strategies to advance your career across all life sciences disciplines. Hosted by Crystal Richards, Principal & Owner, MindsparQ.
➡️ Research — Deep dives on research and opportunities shaping the life sciences ecosystem and their relevance to your professional growth. Hosted by Gautam Kumar, Postdoctoral Candidate, NIH, NIDA
➡️ Biomanufacturing — Insights into the backbone of biotech success, shaping the industry and your career. Hosted by Paris McKenzie, Manufacturing Technician, Longeviti Neuro Solutions.
➡️ CQV & Validation — Insights into compliance, quality systems, and operational standards that underpin high-performing life sciences organizations and support your professional growth. Hosted by Kayla Britt, Founder & Principal Consultant, Britt Biocomputing.
Sponsors
Bio-Trac
With over 40 years of expertise, Bio-Trac® workshops have trained more than 19,500 scientists and engaged 300 scientist instructors. Designed by active researchers and open to the scientific community, these workshops equip bench and research scientists with the latest lab techniques and provide training on cutting-edge biotechnology advancements to a global audience across all biotech sectors.
Workforce Genetics
Workforce Genetics (WGx) is a premier recruiting firm serving the life sciences, MedTech, and healthcare sectors, supporting companies from startup to commercial. The firm delivers transformative talent strategies through retained and executive search, contingent search, and outsourced talent acquisition.
Important Information
BioBuzz's Career Catalyst sessions are intended to provide insights, guidance, and support for professionals navigating their careers. These sessions are not a platform for selling services, recruitment pitches, or business solicitations. They are designed for job seekers and those looking to make connections and build community.
Please be respectful of fellow participants and help ensure this remains a valuable, trusted resource for all.
Participants who engage in solicitation, promotional activity, or behavior that disrupts the intent of the session will be asked to leave.
Repeated or serious violations may result in removal from the session and exclusion from future Career Catalyst events.
Want to be an expert guest?
If you’re interested in sharing your knowledge with the BioBuzz community, get in touch via hello [@] biobuzz.io.