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Shelley Abrams
Shelley Abrams

Shelley Abrams

QA Advisor

Eli Lilly and Company

→ LinkedIn

Laura Adams

Laura Adams

MS&T Lead Engineer
Spark Therapeutics
—> LinkedIn

Jennifer Ahearn

Jennifer Ahearn

Owner/CEO
GMPACT
→ LinkedIn

Mohammed Ali Ait Kassou

Mohammed Ali Ait Kassou

Senior Manager, Business Operations
Pfizer
—> LinkedIn

Amrita Aiden

Amrita Aiden

Director, Global Quality and Compliance, Merck Digital QMS | Innovation | Transformation| Strategy | DEI
Merck
—> LinkedIn

Mohamed Anas Ahmad

Mohamed Anas Ahmad

CSL Behring

Manager, Quality Engineering Process Life Cycle

→ LinkedIn

Elizabeth Bavis

Elizabeth Bavis

Business Change Manager
AstraZeneca
→ LinkedIn

Kim Beaulieu

Kim Beaulieu

Senior Global Regulatory Compliance Auditor
Boston Scientific
—> LinkedIn

Stacey-Ann Bennett

Stacey-Ann Bennett

Project Manager, QMS Compliance and Integration
Baxter
→ LinkedIn

Edwin Bills

Edwin Bills

Principal Consultant
Edwin Bills Consultant
—> LinkedIn

Robin Blankenbaker

Robin Blankenbaker

Digital Thread | Quality System modernization | Product Informatics
Siemens Digital Industries Software
→ LinkedIn

Scott Blood

Scott Blood

Vice President, Quality Assurance & Regulatory Affairs
T2 Biosystems, Inc.
→ LinkedIn

Tarrah Bushee

Tarrah Bushee

Quality Director

Agilent

→ LinkedIn

Wei Cao

Wei Cao

Lead Scientist, Analytical and Quality Control
Spark Therapeutics
→
LinkedIn

Adam Caruso

Adam Caruso

Associate Director, Global Quality Compliance
Merck
—> LinkedIn

Franklin Castro

Franklin Castro

Associate Director, BPD, Process Engineering and Packaging
AstraZeneca
—>LinkedIn

Chris Chaney

Chris Chaney

Quality Assurance Auditor
Elanco
→ LinkedIn

Jerry Chapman

Jerry Chapman

Senior GMP Quality Expert
Redica Systems
—>LinkedIn

Sprinkle Christian

Sprinkle Christian

Design Quality Engineer
Thermo Fisher Scientific
—> LinkedIn

Brent Conatser

Brent Conatser

Principal (Former Elanco, Former FDA)
Qualitas Pharma Consulting, LLC
→ LinkedIn

James Costa, MBA

James Costa, MBA

GMP Materials Management Lead
Spark Therapeutics
—> LinkedIn

Scott Docherty

Scott Docherty

Director - Corporate Quality Assurance / Creativity Trainer
Procter & Gamble
—>LinkedIn

April Doll

April Doll

Global Quality Systems Fellow
Boston Scientific
—> LinkedIn

Aaron Dunbar

Aaron Dunbar

Vice President Quality Systems and Post-Market
Boston Scientific
—> LinkedIn

Shane Dupont

Shane Dupont

Principle Auditor
Boston Scientific
—> LinkedIn

David Elder

David Elder

Principal (Former FDA)
Greenleaf Health, Eliquent Life Sciences
—> LinkedIn

Julie Farley

Julie Farley

Vice President - Global Supplier Quality, India R&D Quality & Business Transformation Quality
Boston Scientific
—> LinkedIn

Bill Farmer

Bill Farmer

Associate Director of Deviation Management
Merck
→ LinkedIn

Constance Y. Fears

Constance Y. Fears

CEO and Principal Consultant
Polymath Regulatory Consultants LLC

—> Linkedin

Rebecca Fechter

Rebecca Fechter

Senior Quality Assurance Specialist
AstraZeneca
→ LinkedIn

Nancy Fulginiti

Nancy Fulginiti

Vice President, Quality
Amring Pharmaceuticals
—> LinkedIn

Mohan Ganapathy

Mohan Ganapathy

Executive Director
Merck
—>LinkedIn

Michael Gosha

Michael Gosha

Sr. Regulatory Affairs Specialist
DePuy Synthes
→ LinkedIn

Karla Longo Gouveia

Karla Longo Gouveia

Associate Director | Quality Assurance | Global Supplier Quality Management
Merck
—>LinkedIn

Ghada Haddad

Ghada Haddad

Executive Director, Global cGMP Compliance and Auditing Organization
Merck
—>LinkedIn

Doug Hamann

Doug Hamann

Principal Device Quality Engineer
AstraZeneca
—>LinkedIn

Asif Hameed

Asif Hameed

Manager, Risk Management
ThermoFisher Scientific
—> LinkedIn

Shylla Haskins

Shylla Haskins

Global Head and Executive Director Global Supplier Quality Management , Global Quality Systems and Compliance
Merck
—>LinkedIn

Eric Hacherl

Eric Hacherl

Owner and Principal Advisor
SMART Bio Works
—> LinkedIn

Tracey Harris

Tracey Harris

Senior Quality Technical Consultant
Baxter Healthcare
→ LinkedIn

Eric Henry

Eric Henry

Senior Quality & Regulatory Compliance Advisor
King & Spalding
—> LinkedIn

Eva Henry

Eva Henry

Global Quality Management Systems
Merck
—> LinkedIn

Ann Hinkle

Ann Hinkle

Director of University Relations and Enrollment
Pathway for Patient Health
—>LinkedIn

Emily Ho

Emily Ho

Combination Product Development and Quality Assurance

Merck

—>LinkedIn

Dru Homer

Dru Homer

Vice President of Quality

MacroGenics, Inc

-->LinkedIn

Shannon Hoste

Shannon Hoste

Chief Scientific Officer (Former FDA)
Pathway for Patient Health
—>LinkedIn

Sunita Virmani Iyer

Sunita Virmani Iyer

Director, Clinical Supply Quality Assurance
AbbVie
—>LinkedIn

Sarah Jennings

Sarah Jennings

Director of Quality, Biologicals and Chemicals Division
ThermoFisher Scientific
—> LinkedIn

Judiann Joyce

Judiann Joyce

Chief Technology Officer
Pathway for Patient Health
—>LinkedIn

Michelle Jump

Michelle Jump

CEO
MedSec
→ LinkedIn

Kathy Kemme

Kathy Kemme

Director, CMC Project Management
PTC Therapeutics
—> LinkedIn

Yoon Kim

Yoon Kim

Senior Director of Design Quality Assurance
ThermoFisher Scientific
—> LinkedIn

Missy Kline

Missy Kline

Senior Manager, Quality Assurance
Forge Biologics
→ LinkedIn

Jennifer Krichten

Jennifer Krichten

Associate Director
Merck
—>LinkedIn

Kyle Kissick

Kyle Kissick

Director, MS&T
Resilience
—>LinkedIn

Christopher Koehler

Christopher Koehler

Quality Manager, Accreditation & Regulatory Compliance
EVERSANA

—> LinkedIn

Michael Koucky

Michael Koucky

Senior Device Engineer
AstraZeneca
—> LinkedIn

John Lepore

John Lepore

Owner
JVL Pharma Consulting LLC

—> LinkedIn

Neil Lewis

Neil Lewis

Retired Technical Senior Director Corporate Quality Assurance
Procter & Gamble
—>LinkedIn

Mao-Shih Liang, Ph.D.

Mao-Shih Liang, Ph.D.

Process Sciences Leader MST
Spark Therapeutics
—> LinkedIn

Betsy Macht

Betsy Macht

Doctoral Mentor, College of Management & Human Potential
Walden University
→ LinkedIn

Michael McCoy

Michael McCoy

Director Of Quality
Abbvie
—> LinkedIn

Mac McKeen

Mac McKeen

RAC, FRAPS, Fellow, Regulatory Science
Boston Scientific Corporation
→ LinkedIn

Pat McNally

Pat McNally

Senior Director, Quality, Drug Product Division
Thermo Fisher Scientific
→ LinkedIn

Marsha Mergy

Marsha Mergy

Director, Device Quality
Eli Lilly
—>LinkedIn

Salima Mody

Salima Mody

Director, Global Quality
Merck
—>LinkedIn

Dale Moore

Dale Moore

Senior Director, Site Quality Lead
Resilience
—>LinkedIn

April Muir

April Muir

Director, Data Integrity (PSG Global Quality Assurance)
Thermo Fisher Scientific
→ LinkedIn

Ann Moody

Ann Moody

Regional Lead - Americas, QMS Shared Services, Quality Systems and Compliance
CSL
→ LinkedIn

Dave Murray

Dave Murray

Sr. Director, Quality

Illumina Inc

→ LinkedIn

Andrea Myers

Andrea Myers

Associate Director, GxP External Engagement-Global Quality GPS
Bristol Myers Squibb
—> LinkedIn

Saddam Nawaz

Saddam Nawaz

Head, Quality Assurance

ACI HealthCare Limited

→ LinkedIn

Steven Niedelman

Steven Niedelman

Lead Quality Systems and Compliance Consultant (Former FDA)
King and Spalding
→ LinkedIn

Randall Obando

Randall Obando

Vice President, Quality Assurance and Regulatory Affairs
Thermo Fisher Scientific
—> LinkedIn

Yenny Ocampo

Yenny Ocampo

Senior Manager - Global Quality Audit Team
Baxter Healthcare
→ LinkedIn

Cathleen Owen

Cathleen Owen

Director, Pharmaceutical & Personal Care Services | cGMP Executive with Quality and Regulatory Expertise
Q Labs
—>LinkedIn

Kristen Parr

Kristen Parr

Senior Consultant
INTERPRO Performance Solutions
→ LinkedIn

Cesar Perez

Cesar Perez

Director, Division of Establishment Support, Office of Regulatory Programs, Center for Device and Radiological Health
FDA
—> LinkedIn

Michael Phelan

Michael Phelan

Quality Assurance Manager
Integral Molecular
—> LinkedIn

Marla Phillips, Ph.D.

Marla Phillips, Ph.D.

CEO and President
Pathway for Patient Health
—>LinkedIn

Deepika Raina

Deepika Raina

Director, Industrial Quality-Manufacturing Hygiene
L’Oréal
→ LinkedIn

Dan Roberts

Dan Roberts

Associate Director, Design Controls Global Process Owner
BD
→ LinkedIn

Neal Schmidt

Neal Schmidt

Senior Manager of Validation
National Resilience, Inc.
—>LinkedIn

Matt Schmucki

Matt Schmucki

Associate Director of Automation Engineering
Vertex Pharmaceuticals

—>LinkedIn

Ketan Shah

Ketan Shah

Executive Director
Merck
—>LinkedIn

Rusty Shreve

Rusty Shreve

Manufacturing Operations Leader
Spark Therapeutics
—> LinkedIn

Blaine Spangler

Blaine Spangler

Associate Director, Quality
Baxter Healthcare
—> LinkedIn

Brooke Stambersky-Wakefield

Brooke Stambersky-Wakefield

Manager, Project Management- Corporate Quality & Regulatory
ThermoFisher Scientific
—> LinkedIn

Jonathan Trethowan

Jonathan Trethowan

European Operations Director
International Pharmaceutical Quality
—>LinkedIn

Kemberly Ullah

Kemberly Ullah

Site Quality Head
ThermoFisher Scientific
—> LinkedIn

Tyler Vandivort

Tyler Vandivort

Director, Regulatory Affairs and Operations
Amplicore Inc.
→ LinkedIn

Abbvie Team Member

Abbvie Team Member

TBA
Abbvie

Alberto Viciedo

Alberto Viciedo

Director, Global Auditing
Merck
→ LinkedIn

Cherri Vorhees

Cherri Vorhees

Senior Global Trainer

Johnson & Johnson Vision

→ LinkedIn

Jamie Wilson

Jamie Wilson

Executive Director Quality, Head of Research Quality
Sage Therapeutics
—> LinkedIn

Geoff Waby

Geoff Waby

Owner
Authentic Quality
→ LinkedIn

Rita Lin

Rita Lin

Director, Human Factors Engineering
Kymanox
→ LinkedIn

David McAnany

David McAnany

V.P. R&D and Regulatory Affairs
QSI Associates
→ LinkedIn

Doug Hamann

Doug Hamann

Sr. Manager QA - Combination Products
Civica Rx
→ LinkedIn

Arijit Roy

Arijit Roy

Principal Regulatory Affairs Specialist
Boston Scientific Corporation
→ LinkedIn

Navia Rodriguez

Navia Rodriguez

Director of Quality Systems and Compliance
Resilience US
→ LinkedIn

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Shelley Abrams
Laura Adams
Jennifer Ahearn
Mohammed Ali Ait Kassou
Amrita Aiden
Mohamed Anas Ahmad
Elizabeth Bavis
Kim Beaulieu
Stacey-Ann Bennett
Edwin Bills
Robin Blankenbaker
Scott Blood
Tarrah Bushee
Wei Cao
Adam Caruso
Franklin Castro
Chris Chaney
Jerry Chapman
Sprinkle Christian
Brent Conatser
James Costa, MBA
Scott Docherty
April Doll
Aaron Dunbar
Shane Dupont
David Elder
Julie Farley
Bill Farmer
Constance Y. Fears
Rebecca Fechter
Nancy Fulginiti
Mohan Ganapathy
Michael Gosha
Karla Longo Gouveia
Ghada Haddad
Doug Hamann
Asif Hameed
Shylla Haskins
Eric Hacherl
Tracey Harris
Eric Henry
Eva Henry
Ann Hinkle
Emily Ho
Dru Homer
Shannon Hoste
Sunita Virmani Iyer
Sarah Jennings
Judiann Joyce
Michelle Jump
Kathy Kemme
Yoon Kim
Missy Kline
Jennifer Krichten
Kyle Kissick
Christopher Koehler
Michael Koucky
John Lepore
Neil Lewis
Mao-Shih Liang, Ph.D.
Betsy Macht
Michael McCoy
Mac McKeen
Pat McNally
Marsha Mergy
Salima Mody
Dale Moore
April Muir
Ann Moody
Dave Murray
Andrea Myers
Saddam Nawaz
Steven Niedelman
Randall Obando
Yenny Ocampo
Cathleen Owen
Kristen Parr
Cesar Perez
Michael Phelan
Marla Phillips, Ph.D.
Deepika Raina
Dan Roberts
Neal Schmidt
Matt Schmucki
Ketan Shah
Rusty Shreve
Blaine Spangler
Brooke Stambersky-Wakefield
Jonathan Trethowan
Kemberly Ullah
Tyler Vandivort
Abbvie Team Member
Alberto Viciedo
Cherri Vorhees
Jamie Wilson
Geoff Waby
Rita Lin
David McAnany
Doug Hamann
Arijit Roy
Navia Rodriguez
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