Owner/CEO, GMPACT LLC

— 25+ years experience in FDA and Industry
— Former FDA Office of Criminal Investigations Technical Liaison, working on criminal investigations with FDA and FBI agents
— Provided testimony in cases from FDA’s Office of General Council, Department of Justice, US Attorney’s Office and CDER
— Former Senior Forensic Scientist, Georgia Bureau of Investigation

Quality Assurance Auditor, Elanco

— 26+ years industry experience, spanning laboratory operations, manufacturingsciences and technical services, microbiology, and quality assurance
— Responsible for auditing internal manufacturing sites, affiliates, contract manufacturers, suppliers and GMP service providers
— Conduct Due Diligence audits for business acquisitions and partnerships

Lead Quality Advisor, Elanco

— 39 years experience in FDA and indsutry
— Served as an FDA investigator and compliance officer during the Generic Drug Scandal
— Former Janssen Manager of Regulatory Affairs in Belgium, and Associate Director of Worldwide Compliance for Pfizer
— Joined Eli Lilly in 2002 in Quality Assurance, which then split off Elanco in 2015. Served in External Intelligence and was a Lead Quality Advisor

Principal, Greenleaf Health

— 23+ year veteran of FDA
— Retired Captain, U.S. Publich Health Service
— Former FDA Director, Office of Regional Operations. Responsible for National Expert Investigators, Team Biologics Investigators, and dedicated foreign inspection cadres
— Former Director, Office of Enforcement
— Former Director, Office of Compliance

Associate Director of Deviation Management, Merck

— Experienced industry veteran from Merck and GSK
— A Quality Management System Executive at GSK, Verification Manager and Quality Team Leader
— Involved in industry forums related to deviations and human performance - always striving to “Make it easier to do the right thing, harder to do the wrong thing”

Senior Quality Technical Consultant, Baxter Healthcare

— 15+ years experience in industry and FDA
— Coporate Internal and 3rd Party Audits for Baxter
— Former FDA Investigator - Pharmaceutical Focus
— Former Member of the FDA Foreign Inspection Cadre
— Former Chemistry Instructor, Sinclair Community College

Senior Quality & Regulatory Compliance Advisor, FDA & Life Sciences Practice. King & Spalding

— 28+ years experience in industry
— Deep experience in Software Design Controls, Software as a Medical Device and Software in a Medical Device
— Design Controls leadership at Hologic, Boston Scientific, GE Healthcare, Medtronic and Philips
— Graduate lecturer at Temple University and frequent global conference expert presenter

Regional Lead - Americas, CSL Behring

— Responsible for Quality Management System shared services, Quality Systems and Compliance at CSL Behring
— Deep background in adult learning excellence and communication, with great passion for employee success
— Conference presenter on training effectiveness and the human element

Quality Director - Data Integrity Officer

— 25+ years of industry experience
— Leads global data integrity work across policies, procedures, escalation, deviations and training
— Expert in analytical development, methods and systems
— Became a Manager of Quality Assurance for Thermo Fisher (now owner of Patheon), and led auditing, batch release, quality control data review and training
— Began as a research chemist at Cardinal Health

Lead Quality Systems and Compliance Consultant, King & Spalding

— 34+ year veteran of FDA, and 47+ years experience overall
— Former FDA Deputy Associate Commissioner for Regulatory Affairs, with responsibilty for all investigators in the country
— Expert investigator, with special focus in medical devices
— Extensive external engagement as a conference committee member, conference speaker and forum member with many FDA/industry forums.

Senior Manager - Global Quality Audit Team, Baxter Healthcare

— 27+ year industry professional
— Based in Colombia, and experienced in global audits and inspections
— Part of the Baxter Global Quality Audit Team
— Chemical Engineer

CEO and President, Pathway for Patient Health

— 28+ years of industry experience
— Former Merck, Head of Quality for North Carolina Facility
— 14.5 years of experience in leading initiatives with global regulators and industry experts across pharma, device, combination products and artificial intelligence
— Deep understanding of what drives human behavior and how to affect exceptional outcomes

Associate Director - Corporate Audits, Baxter Healthcare

— 20+ year industry professional
— Former Hospira Investigations/CAPA Manager - Plant Quality Operations
— Former Abbott QUality Engineer, Investigations Supervisor, Lead Investigator and Lead Microbiologist