Summit Chairs

Kalah Auchincloss
Kalah Auchincloss
Executive VP and Deputy General Counsel
Greenleaf Health
David Chesney
David Chesney
Principal and General Manager
DL Chesney Consulting LLC
Eric Henry
Eric Henry
Sr. Quality Systems & Compliance Advisor
FDA & Life Sciences Practice, King & Spalding
Michelle Webb
Michelle Webb
Vice President, Avoca Quality Consortium
WCG Avoca

FDA Speakers

Elizabeth Miller
Elizabeth Miller
Asst Commissioner Medicals Products & Tobacco Ops
US FDA
Simone Pitts
Simone Pitts
FDA National Expert, Pharmaceutical
US FDA
Francisco Vicenty
Francisco Vicenty
Program Manager, Case for Quality
CDRH, FDA
Daniel Walter
Daniel Walter
Policy Analyst
US FDA

Speakers

Jeff Ballyns
Jeff Ballyns
Associate Director, Regulatory Policy, Public Affairs
Becton Dickenson
Thomas Berry
Thomas Berry
Senior Vice President, Regulatory Compliance
Greenleaf Health, Inc
Ron Branning
Ron Branning
CEO
GXPQS LLC
Cathy Burgess
Cathy Burgess
Partner
Alston & Bird
Trevor Cole
Trevor Cole
Associate Director
WCG
Bob Darius
Bob Darius
Head of Compliance Specialty Care
Sanofi
Patrick Day
Patrick Day
Principal Consultant
Lachman Consultants
Ted Finlan
Ted Finlan
Senior Vice President for Project Planning and Administration
Worldwide Clinical Trials
Christopher Gates
Christopher Gates
Director of Product Security
Velentium
Karen Harvey
Karen Harvey
Senior Director
WCG Avoca
Neala Lane
Neala Lane
Associate Director, Quality Improvement Office
Indiana University
Julie Larsen
Julie Larsen
Principal & COO
BioTeknica, Inc.
Grace McNally
Grace McNally
Senior Vice President
Greenleaf Health, Inc.
William Mestrandrea
William Mestrandrea
Senior Director, Global GMP/GDP Audit
Bristol Myers Squibb
Téa Romero
Téa Romero
Client Success Manager
Clario
Mark Schwartz
Mark Schwartz
Director
Hyman Phelps
Gary Shorter
Gary Shorter
Senior Director of Emerging Technology and AI
IQVIA Tech
Kamal Sigel
Kamal Sigel
Vice President, Quality
CymaBay Therapeutics. Inc
Kara Stockett Quinn
Kara Stockett Quinn
Senior Consultant
ValSource Consulting
Linda Sullivan
Linda Sullivan
Senior Advisor, Metrics & Performance Management
WCG
Sarah Tanksley
Sarah Tanksley
President and CEO
Tanksley Consulting
John Taylor
John Taylor
President; Principal of Regulatory Compliance
Greenleaf Health, Inc.
Scott Thiel
Scott Thiel
Global Head of Regulatory Policy and Intelligence
Hologic
Kim Trautman
Kim Trautman
Managing Director and Vice President
MEDIcept, Inc.
Jeff Yuen
Jeff Yuen
Founder, President and CEO
Jeff Yuen & Associates, Inc.