Speakers

Below are confirmed speakers for the 43rd International GMP Conference. Please see the agenda for additional speakers and organizations with pending invitations.

 

Jennifer Ahearn
Director - 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
QxP

"Cell and Gene Therapy Quality Considerations"

Thurs., 3/14 9:00-9:45 a.m. 

Ileana Barreto-Pettit
Drug National Expert Investigator - FDA ORA

"Case Studies from GMP Inspections"

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

Dan Barreto
Senior Vice President - Teva

"Compliance Trends and Issues for the Generic Industry"

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

Ginette Collazo
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 - QxP

"Elemental Impurities"

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

Thomas Friedli
Director, Quality Management Program - University of St. Gallen

"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, External Advocacy - AstraZeneca (Sweden)

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

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

Anthony Lostracco
Regional Compliance Specialist - Health Canada

"Health Canada Inspection Trends and Case Studies"

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

Marie Mathews
Compliance Officer - FDA CDER

"Ingredient Supplier Qualification"

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

William Mestrandrea
Sr. Director, GMP/GDP Compliance - Celgene

"Making Better Decisions in a Regulated Environment — Cognitive Bias and Critical Thinking"

Wed., 3/13 8:15-9:00 a.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
Lead Regulatory Compliance Officer - FDA CDER

"FDA Oversight of Drug Compounding"

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

Ted Ross
Professor, GRA Eminent Scholar of Infectious Disease, Director of Center for Vaccines and Immunology - University of Georgia

"Universal Influenza Vaccines"

Tues., 3/12 6:30 p.m. 

Anil Sawant
Vice President - Merck

"Assuring GXP Data Integrity – Cybersecurity"

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

Ronald Tetzlaff
Vice President - Parexel Consulting

"Update from PDA Task Force on Data Integrity"

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

Eva Urban
Associate Director, Global GMP/GDP Compliance, QRM - Celgene (Switzerland), PDA Quality Group

"QRM in PQS: The Future Shape"

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

Johnetta Walters
Investigator/Pre-Approval 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
Director, Compliance, Remediation and Support - Merck

"Trend Analysis and CAPA Verification"

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