Speakers

Below are confirmed speakers for the 43rd International GMP Conference.

Jennifer Ahearn
Director of Regulatory and Compliance - Engineering Systems, Inc.

"Complaint Handling: How Far Should You Go?"

Wed., 3/13 1:15-2:00 p.m.

"Trend Analysis and CAPA Verification"

Thurs., 3/14 1:00-2:30 p.m. (Post-Conference Tutorial)

Vivianne Arencibia
Quality Executive Partners (QxP), Inc.

"Quality Concepts for Personalized Cell and Gene Therapies"

Thurs., 3/14 9:00-9:45 a.m. 

Ileana Barreto-Pettit
Drug National Expert - FDA ORA

"Case Studies from GMP Inspections"

Wed., 3/13 10:30-11:15 a.m.

Michael Bartlett, Ph.D.
Professor - University of Georgia

"Welcome and Orientation"

Tues., 3/12 8:30-8:45 a.m.

Ginette Collazo, Ph.D.
Owner - Human Error Solutions

"Controlling Human Error on the Manufacturing Floor"

Tues., 3/12 4:00-4:45 p.m.

Alonza Cruse
Director, Office of Pharmaceutical Quality Operations - FDA ORA

"Update from the Office of Regulatory Affairs"

Tues., 3/12 8:45-9:30 a.m.

Melissa Figgins
Senior Partner - Quality Executive Partners (QxP), Inc.

"Elemental Impurities"

Thurs., 3/14 10:30-11:15 a.m.

Thomas Friedli, Ph.D.
Professor for Production Management - University of St. Gallen (Switzerland)

"Quality Metrics and Operational Excellence: Bringing together what belongs together — Insights from a Decade of Research"

Tues., 3/12 3:15-4:00 p.m.

Tor Gråberg
Head of Operations, Quality Compliance and External Affairs - AstraZeneca (Sweden)

"What Practical Impact Will Brexit Have? A View from Pharma Companies"

Wed., 3/13 3:30-4:15 p.m.

Steve Greer
Leadership Coach and Quality Leader - Procter & Gamble

"Leading Change to Improve Human Performance"

Tues., 3/12 1:00-1:45 p.m.

Anthony Lostracco
Acting Supervisor of Drug GMP Inspection Unit - Health Canada

"Health Canada Inspection Trends and Case Studies"

Wed., 3/13 4:15-5:00 p.m.

Marie Mathews
Compliance Officer - FDA CDER

“From API Supplier Qualification to Warning Letter: Case Studies”

Thurs., 3/14 11:15 a.m. - 12:00 p.m.

Alan Minsk
Partner and Practice Leader of Food and Drug Team - Arnall Golden Gregory, LLP

"Medical Product Communications"

Wed., 3/13 2:00-2:45 p.m.

Hidee Molina
Senior Team Lead, Office of Manufacturing Quality, Office of Compliance - FDA CDER

"FDA Oversight of Drug Compounding"

Thurs., 3/14 8:15-9:00 a.m.

Ted Ross, Ph.D.
Professor, Director of Center for Vaccines and Immunology - University of Georgia

"Towards A Universal Influenza Vaccine: Lessons from the Great Influenza Pandemic of 1918 to Now"

Tues., 3/12 6:30 p.m. 

Anil Sawant, Ph.D.
Head of Global Quality Compliance, MMD - Merck

"Assuring GXP Data Integrity – Cybersecurity"

Tues., 3/12 10:15-11:00 a.m.

Sam Silva, Ph.D.
Executive Director and Cofounder - SEMS Farmaceutica (Brazil)

"Biologics Strategy for Brazil"

Wed., 3/13 8:15-9:00 a.m.

Kelly Smith, Pharm.D.
Dean - University of Georgia College of Pharmacy

"Welcome and Orientation"

Tues., 3/12 8:00-8:45 a.m.

Ronald Tetzlaff, Ph.D.
Vice President - Parexel Consulting

"Update from PDA Task Force on Data Integrity"

Tues., 3/12 1:45-2:30 p.m.

Eva Urban
Global QRM Process Business Owner - Celgene (Switzerland)

"QRM in PQS: The Future Shape"

Tues., 3/12 11:00-11:45 a.m.

Johnetta Walters, Ph.D.
Pre-Approval Program Manager - FDA ORA

"Preparing for FDA Pre-Approval Inspections"

Wed., 3/13 11:15 a.m. - 12:00 p.m.

Ted Wheeler
Director, Quality Assurance - Aerie Pharmaceuticals

"Virtual Manufacturing Challenges"

Wed., 3/13 9:00-9:45 a.m. 

Bob Wittorf, Pharm.D.
Director of Compliance, Remediation and Support, Global Quality Assurance and External Affairs - Merck

"Trend Analysis and CAPA Verification"

Thurs., 3/14 2:45-4:00 p.m. (Post-Conference Tutorial)