THOUGHT LEADERSHIP — SPEAKING
Bringing regulatory science expertise to the stages and screens where it matters most.
Sandi Schaible is an established speaker on chemical characterization, biocompatibility, extractables & leachables, and regulatory strategy — delivering practical, standards-grounded insight to conference audiences, association events, and corporate teams.
Sandi Schaible
Founder, Bonded in Science
35+
Years regulatory
science experience
ISO
TC194 committee
expert & contributor
GLOBAL
Available US and International
Industry conferences
Keynote, panel, workshop
Association
events
SOT, MD&M
Webinars & virtual events
Live or pre-recorded
Corporate education
Team training sessions
Speaking Engagements
From intimate webinars to global conferences, here’s where I’ll be sharing insights and strategies in the coming months.
Where you can hear me speak
From intimate webinars to Global Conferences here is where I'll be sharing insights and strategies in the coming months.
Webinar
Event Name: BioPharma Webinars
Date & Time: 📅 Sept 22, 2026 | ⏰ 9:30 EDT/6:30AM PDT/2:30PM BST/3:30PM CEST
Location: Online (Free)
Description: Future Path for E&L per ISO 10993-18: A Look at Emerging Technical Specifications
Register Now: biopharmawebinars.com/webinars/future-path-for-el-per-iso-10993-18-a-look-at-emerging-technical-specifications/
Conference
Event Name: Biocompatibility Insights
Date & Time: 📅Oct 13-14
Location: Copenhagen, Denmark
Description: Fit for Purpose Chemical Characterization Studies for Medical Devices: A Practical Approach
Register Now: Event Biocompatibility Insights 2026 | Veranex
Trade Show
Event Name: MD&M Midwest
Date & Time: 📅 Oct 28-29, 2026
Location: Minneapolis, MN
Description: When Chemistry Fails: A Case Study on How Cross Functional Misalignment Triggers Compliance Risk
Register Now: MD&M Midwest 2026– The Midwest’s Largest Design & Manufacturing Event
About Sandi as a speaker
Sandi Schaible brings a perspective to the stage that very few speakers in regulatory science can match — the combination of 35 years of hands-on technical experience, executive leadership, and active involvement in the international standards that govern the field.
As an active member of the ISO TC194 committee, Sandi doesn't just interpret the standards she speaks about — she contributes to writing them. That insider perspective translates into talks that are technically rigorous, practically grounded, and genuinely useful to audiences at every level.
Her style is direct and candid. She speaks plainly about where the industry gets things wrong, what regulators actually look for, and what good science looks like in practice — not in theory.
"The best regulatory science talks don't just explain what the standards say — they explain why the standards say it, and what the consequences are when organizations miss that distinction."
— Sandi Schaible
SPEAKING TOPICS
Five areas of deep expertise — one consistent thread
Every talk Sandi delivers is grounded in 35 years of hands-on regulatory science experience and active ISO TC194 committee work. These aren't overviews — they're the perspectives of someone who has been inside the standards, the lab, and the regulatory process.
Topic 01
Biocompatibility & ISO 10993
Navigating the evolving standard — what's changing in the ISO 10993 series, how to build defensible biological evaluation programs, and where most organizations are still getting it wrong. Delivered from the perspective of an active TC194 committee member.
Topic 03
Chemical characterization
The full picture of chemical characterization — from paper-based assessments and prior knowledge reviews through instrumental techniques (E&L, FTIR, SEM, DSC, particle counting) and extraction chemistry. How to select the right approach for the right material and the right risk level.
Topic 02
Extractables & Leachables
What good E&L science actually looks like — study design, analytical methodology, risk assessment, and how to build programs that hold up under regulatory scrutiny. Written for both labs conducting the work and companies commissioning it
Topic 04
Regulatory strategy & FDA submissions
Translating complex chemical and toxicological data into clear, defensible regulatory narratives. Submission planning, deficiency response, and how to build a regulatory story that moves through review — not around it.
Topic 05
Leadership & building regulatory science teams
What it takes to build high-performing regulatory science functions from the ground up. A strategic perspective for life science executives and organizational leaders navigating growth.
PAST ENGAGEMENTS
On the conference circuit — past and upcoming
Sandi speaks at leading industry conferences, association events, and professional webinars on chemical characterization, extractables & leachables, biocompatibility, and regulatory strategy. A selection of recent and upcoming engagements is listed below.
PharmaEd East E&L Conference
April 2026 In-person Session speaker
Emerging Specifications in ISO 10993-18
A deep dive into the evolving requirements of ISO 10993-18 and what the emerging specifications mean for extractables and leachables programs in practice — covering what's changing, why it matters, and how organizations should be adapting their approaches now.
Biocompatibility Insights
October 2026 In-person Session speaker
Fit-for-Purpose E&L Testing
A practical Approach
A look at how chemical characterization is typically approached today and 3 suggestions for improving the process and science.
BioPharma Webinars
September 2026 Live webinar Keynote speaker
Emerging Specifications in ISO 10993-18
Keynote presentation examining the latest developments in ISO 10993-18 and their practical implications for pharmaceutical and device organizations managing chemical characterization programs. A forward-looking perspective from an active ISO TC194 committee member.
MD&M Midwest
October 2026 In-person Session speaker
When Chemistry Fails: A Case Study on How Cross‑Functional Misalignment Triggers Compliance Risk
A fictionalized case study to show how small chemistry signals, missed supplier changes, and unclear cross‑functional communication can escalate into major compliance challenges.
Interested in having Sandi speak at your event? Inquire using the link above — atleast 3 months lead time preferred for all engagements. Limited dates available per quarter.