Published Articles


Change Control: The Most Boring Topic That Can Make Or Break Your Life Science Company

https://www.linkedin.com/pulse/change-control-most-boring-topic-can-make-break-your-life-starkey-auwfc

Quality vs. Operations: The Most Expensive Rivalry in Life Sciences

https://www.linkedin.com/pulse/quality-vs-operations-most-expensive-rivalry-life-sciences-starkey-kdvkc

D’OH! So you’ve got a 483. What’s next?

https://www.linkedin.com/pulse/doh-so-youve-got-483-whats-next-joanne-starkey-xopnc

PFAS in Cosmetics: The FDA Speaks

https://www.linkedin.com/pulse/pfas-cosmetics-fda-speaks-joanne-starkey-cwcpc

Compliance Goals for 2026: The Year We Get Ahead

https://www.linkedin.com/pulse/compliance-goals-2026-year-we-get-ahead-joanne-starkey-zg8gc

AI in eQMS: Bridging the Gap Between Capability and Compliance

https://www.linkedin.com/pulse/ai-eqms-bridging-gap-between-capability-compliance-joanne-starkey-zieic

FDA Warning Letters: What They Mean, How to Respond, and How to Avoid Them In the First Place

https://www.linkedin.com/pulse/fda-warning-letters-what-mean-how-respond-avoid-them-first-starkey-imxtc

FDA’s Shift from QSR to QMSR: What It Means and How to Prepare

https://www.linkedin.com/pulse/fdas-shift-from-qsr-qmsr-what-means-how-prepare-joanne-starkey-o6ybc

Big Talent Need, Small Talent Budget: The Power of Fractional Leadership in Life Sciences

https://www.linkedin.com/pulse/big-talent-need-small-budget-power-fractional-life-sciences-starkey-lpgrc

“May You Live in Interesting Times”: The Curse of Uncertainty for GxP Regulated Industries

https://www.linkedin.com/pulse/may-you-live-interesting-times-curse-uncertainty-gxp-joanne-starkey-khjqc

FDA Releases 2025 Investigations Operations Manual: What It Means for Your Next Inspection

https://www.linkedin.com/pulse/fda-releases-2025-investigations-operations-manual-what-starkey-eei3c

The Emerging Role of AI in Electronic Quality Management Systems for FDA and ISO-Compliant Companies

https://www.linkedin.com/pulse/emerging-role-ai-electronic-quality-management-systems-joanne-starkey-8o3ac

Does Your Current Org Chart Have Quality Issues?

https://www.linkedin.com/pulse/does-your-current-org-chart-have-quality-issues-joanne-starkey-elopc

The Case for a Fractional Chief Quality Officer (CQO)

https://www.linkedin.com/pulse/case-fractional-chief-quality-officer-cqo-joanne-starkey-mqytc

(21) Wrapping your arms around Quality Debt: How understanding this simple concept can make or break your compliant company. | LinkedIn