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A
Agrawal, Atul
U.S. FDA
Live Q&A (C5)
Atul Agrawal
Favorite
Anderson, Kristen
U.S. FDA
Review-Based Live Q&A
Kristen Anderson
Favorite
Review-Based Panel Discussion
Kristen Anderson
Favorite
Anderson, Maria
U.S. FDA
CBER Compliance Update
Maria Anderson
Favorite
Live Q&A (P4)
Maria Anderson
Favorite
Ashley, Donald
U.S. FDA
CDER Compliance Updates
Donald Ashley
Favorite
Live Q&A (P3)
Donald Ashley
Favorite
Ayres, John
Pharma Safety Solutions, LLC
Live Q&A (P3)
John Ayres
Favorite
Plenary 3: Compliance Office Updates
John Ayres
Favorite
B
Baker, Denyse
AstraZeneca
Live Q&A (ST2)
Denyse Baker
Favorite
Quality Management Maturity and Metrics - Perspective from the PDA QMM Task Force
Denyse Baker
Favorite
Baker, Tiffany
ValSource Inc.
Live Q&A (ST6)
Tiffany Baker
Favorite
The Use of QRM to Ensure Process and Product Control During Non-Ingredient Material Shortage
Tiffany Baker
Favorite
Balcer, Paul
U.S. FDA
B1: Supply Chain Collaboration and Product Approvals during a Pandemic
Paul Balcer
Favorite
Live Q&A (B1)
Paul Balcer
Favorite
Barbosa, Robert
U.S. FDA
Live Q&A (ST3)
Robert Barbosa
Favorite
Bedford, Jeff
GlaxoSmithKline
Live Q&A (C4)
Jeff Bedford
Favorite
Quality in Automation
Jeff Bedford
Favorite
Blosser, Renée
U.S. FDA
Live Q&A (ST6)
Renée Blosser
Favorite
Boam, Ashley
U.S. FDA
Engaging Stronger Together: A Regulatory Perspective
Ashley Boam
Favorite
Live Q&A (P2)
Ashley Boam
Favorite
Boyd, Sandra
U.S. FDA
Inspection-Based Live Q&A
Sandra Boyd
Favorite
Inspection-Based Panel Discussion
Sandra Boyd
Favorite
Live Q&A (A2)
Sandra Boyd
Favorite
Broadfoot, Jeff
Emergent BioSolutions Inc.
Live Q&A (ST2)
Jeff Broadfoot
Favorite
Burnsteel, Cindy
U.S. FDA
CVM Compliance Updates
Cindy Burnsteel
Favorite
Live Q&A (P3)
Cindy Burnsteel
Favorite
C
Cai, Bing
U.S. FDA
Review-Based Live Q&A
Bing Cai
Favorite
Review-Based Panel Discussion
Bing Cai
Favorite
Campa, Cristiana
GlaxoSmithKline
Live Q&A (ST4)
Cristiana Campa
Favorite
Quality by Design: An Indispensable Approach to Accelerate BioPharmaceutical Product Development
Cristiana Campa
Favorite
Campbell, Douglas
InterPro QRA
B5: Sterile Drug Hot Topics
Douglas Campbell
Favorite
Live Q&A (B5)
Douglas Campbell
Favorite
Casey, Monica
U.S. FDA
Live Q&A (P4)
Monica Casey
Favorite
Cavazzoni, Patrizia
U.S. FDA
Live Q&A (P1-Cavazzoni)
Patrizia Cavazzoni
Favorite
Updates from CDER
Patrizia Cavazzoni
Favorite
Chen, Gang
Regeneron Pharmaceuticals, Inc.
Live Q&A (C2)
Gang Chen
Favorite
Chesney, David
DL Chesney Consulting, LLC
Inspection-Based Live Q&A
David Chesney
Favorite
Inspection-Based Panel Discussion
David Chesney
Favorite
Live Q&A (P4)
David Chesney
Favorite
Plenary 4: Current GMP Compliance Trends and Topics
David Chesney
Favorite
Christensen, Jette
Novo Nordisk A/S
Welcome and Opening Remarks from PDA Leadership and Conference Co-Chairs
Jette Christensen
Favorite
Collins, Alicia
Bristol Myers Squibb
Capacity Planning for Individualized Therapies
Alicia Collins
Favorite
Live Q&A (C1)
Alicia Collins
Favorite
Collins, Conor
GlaxoSmithKline
Live Q&A (A4)
Conor Collins
Favorite
Process Validation Lifecycle: Benefits and Learnings from Implementation
Conor Collins
Favorite
Coulon, Carl-Helmut
INVITE GmbH
Facilitating Deployment of Autonomous Mobile Robotics (AMRs)
Carl-Helmut Coulon
Favorite
Live Q&A (C3)
Carl-Helmut Coulon
Favorite
Cowley, Darrin
AstraZeneca
Live Q&A (P1-Cowley)
Darrin Cowley
Favorite
Operating during a Global Pandemic Lessons Learned: Development through Production
Darrin Cowley
Favorite
Cruse, Alonza
U.S. FDA
Live Q&A (P3)
Alonza Cruse
Favorite
ORA Compliance Updates
Alonza Cruse
Favorite
D
Dasgupta, Biswarup
NA
Holistic Contamination Control Strategy (CCS) for Sterile Drugs including Cell and gene Therapy Products
Biswarup Dasgupta
Favorite
Live Q&A (B5)
Biswarup Dasgupta
Favorite
De Moor, Pamela
Vir Biotechnology, Inc
Delivering Therapeutic mAbs for COVID-19: What Can Be Done in Just One Year
Pamela De Moor
Favorite
Live Q&A (C2)
Pamela De Moor
Favorite
Demarest, Kathy
Amgen Inc.
Live Q&A (B3)
Kathy Demarest
Favorite
"This was their finest hour." -Winston Churchill Manufacturing During a Global Pandemic
Kathy Demarest
Favorite
Dick, Andrew
KDC/One
Live Q&A (A2)
Andrew Dick
Favorite
Microbiological Contamination Controls for Nonsterile Manufacturing
Andrew Dick
Favorite
DiGiulio, Denise
Genentech
A3: Quality Systems: How to Ensure Resilience and Effectiveness
Denise DiGiulio
Favorite
Live Q&A (A3)
Denise DiGiulio
Favorite
Review-Based Live Q&A
Denise DiGiulio
Favorite
Review-Based Panel Discussion
Denise DiGiulio
Favorite
Dombrowski, Rebecca
U.S. FDA
C3: Improving Manufacturing via Modern Technology
Rebecca Dombrowski
Favorite
Live Q&A (C3)
Rebecca Dombrowski
Favorite
Live Q&A (ST5)
Rebecca Dombrowski
Favorite
Special Topic 5: AI Research Force (AIRForce) Group: Focus on Artificial Intelligence and Machine Learning
Rebecca Dombrowski
Favorite
Duncan, Derek
Lighthouse Instruments
Effects of Ultra-Cold Chain Storage and Distribution on Vial Container Closure Integrity
Derek Duncan
Favorite
Live Q&A (ST1)
Derek Duncan
Favorite
E
Edey, Michael
Pfizer Inc.
Live Q&A (ST1)
Michael Edey
Favorite
Mitigating Risk to Container Closure Integrity of a COVID-19 Vaccine Product during Ultra-Cold Chain Storage and Distribution
Michael Edey
Favorite
Edson, Paul
Johnson & Johnson
Live Q&A (A3)
Paul Edson
Favorite
F
Farbman, Mary
Merck & Co., Inc.
B3: Manufacturing during and after the Pandemic
Mary Farbman
Favorite
Live Q&A (B3)
Mary Farbman
Favorite
Live Q&A (P6)
Mary Farbman
Favorite
Live Q&A (ST3)
Mary Farbman
Favorite
Plenary 6: Thanks Science
Mary Farbman
Favorite
Review-Based Live Q&A
Mary Farbman
Favorite
Review-Based Panel Discussion
Mary Farbman
Favorite
Special Topic 3: Current Microbiology Topics
Mary Farbman
Favorite
Frick, Travis
Istari Oncology
Forthcoming PDA Technical Report on Utilizing the Quality Management System to assure Data Integrity
Travis Frick
Favorite
Live Q&A (C5)
Travis Frick
Favorite
Friedman, Rick
U.S. FDA
A1: Managing Investigations in a Global Network
Rick Friedman
Favorite
Live Q&A (A1)
Rick Friedman
Favorite
Live Q&A (A5)
Rick Friedman
Favorite
G
Gabriele, Mirko
ThermoFisher Scientific
Live Q&A (B2)
Mirko Gabriele
Favorite
Risk Management in Technology Transfer: The Receiving Site Perspective
Mirko Gabriele
Favorite
Gaines, Victor (Ray)
U.S. FDA
Live Q&A (A1)
Victor (Ray) Gaines
Favorite
Ganjawala, Milind
U.S. FDA
Live Q&A (A4)
Milind Ganjawala
Favorite
Process Validation Lifecycle: 10 Years in Review
Milind Ganjawala
Favorite
Godwin, Francis
U.S. FDA
CDER/OC/OMQ Update
Francis Godwin
Favorite
Closing Remarks
Francis Godwin
Favorite
Live Q&A (P1-Cavazzoni)
Francis Godwin
Favorite
Live Q&A (P1-Cowley)
Francis Godwin
Favorite
Live Q&A (P4)
Francis Godwin
Favorite
Plenary 1: Opening Plenary
Francis Godwin
Favorite
Welcome and Opening Remarks from PDA Leadership and Conference Co-Chairs
Francis Godwin
Favorite
Gooen Bizjak, CDR Tara
U.S. FDA
A4: Process Validation Lifecycle: 10 Years in Review
CDR Tara Gooen Bizjak
Favorite
Inspection-Based Live Q&A
CDR Tara Gooen Bizjak
Favorite
Inspection-Based Panel Discussion
CDR Tara Gooen Bizjak
Favorite
Live Q&A (A4)
CDR Tara Gooen Bizjak
Favorite
Live Q&A (B2)
CDR Tara Gooen Bizjak
Favorite
Live Q&A (B3)
CDR Tara Gooen Bizjak
Favorite
Manufacturing During and After the Pandemic: A Regulatory Perspective
CDR Tara Gooen Bizjak
Favorite
Guilfoyle, Dennis
Johnson & Johnson
Do Environmental Isolates have a Role in Method Suitability and Growth Promotion in the Microbiology Laboratory?
Dennis Guilfoyle
Favorite
Live Q&A (ST3)
Dennis Guilfoyle
Favorite
Gutierrez Lugo, Maria
U.S. FDA
Live Q&A (C2)
Maria Gutierrez Lugo
Favorite
Regulatory Approaches to Accelerated SARS-CoV-2 Neutralizing Antibody Development
Maria Gutierrez Lugo
Favorite
H
Harrington, Rachel
U.S. FDA
Inspection-Based Live Q&A
Rachel Harrington
Favorite
Inspection-Based Panel Discussion
Rachel Harrington
Favorite
Hartsock, Sharyl
Eli Lilly and Company
C5: All That Data…Now What?
Sharyl Hartsock
Favorite
Live Q&A (C5)
Sharyl Hartsock
Favorite
Henrici, Kir
The Henrici Group
Forthcoming PDA Technical Report on Utilizing the Quality Management System to assure Data Integrity
Kir Henrici
Favorite
Live Q&A (C5)
Kir Henrici
Favorite
Higgins, Brooke
U.S. FDA
Hot Topics and Regulatory Expectations in Aseptic Processing
Brooke Higgins
Favorite
Live Q&A (B5)
Brooke Higgins
Favorite
Hotez, Peter
Baylor College of Medicine
Live Q&A (P6)
Peter Hotez
Favorite
Vaccine Diplomacy in a Time of Doubt in Science
Peter Hotez
Favorite
Huffman, Laura
U.S. FDA
Inspection-Based Live Q&A
Laura Huffman
Favorite
Inspection-Based Panel Discussion
Laura Huffman
Favorite
Hughes, Patricia
U.S. FDA
A5: Aging Facilities vs. Modern Facilities
Patricia Hughes
Favorite
C2: Drug Quality Lifecycle: Current Regulatory Concerns
Patricia Hughes
Favorite
Live Q&A (A5)
Patricia Hughes
Favorite
Live Q&A (C2)
Patricia Hughes
Favorite
Live Q&A (ST6)
Patricia Hughes
Favorite
Review-Based Live Q&A
Patricia Hughes
Favorite
Review-Based Panel Discussion
Patricia Hughes
Favorite
Risk Management of Non-Ingredient Suppliers: Current Regulatory Concerns
Patricia Hughes
Favorite
Hutchens, Clarice
Pfizer
B4: ICH’s Initiatives to Advance Global Harmonization, Innovation, and Continual Improvement Throughout Lifecycle
Clarice Hutchens
Favorite
Live Q&A (B4)
Clarice Hutchens
Favorite
Live Q&A (ST2)
Clarice Hutchens
Favorite
Special Topic 2: Quality Management Maturity (QMM) and Metrics: What Does the Future Hold?
Clarice Hutchens
Favorite
Huynh, Mai
U.S. FDA
Inspection-Based Live Q&A
Mai Huynh
Favorite
Inspection-Based Panel Discussion
Mai Huynh
Favorite
Live Q&A (ST6)
Mai Huynh
Favorite
Special Topic 6: Risk Management of Non-Ingredient Suppliers
Mai Huynh
Favorite
J
Johnson, Richard
PDA
Welcome and Opening Remarks from PDA Leadership and Conference Co-Chairs
Richard Johnson
Favorite
Jornitz, Maik
G-CON Manufacturing, Inc.
Impact of Aging Facilities on the Issue of Drug Shortage
Maik Jornitz
Favorite
Live Q&A (A5)
Maik Jornitz
Favorite
K
Khan, Amin
GreenLight Biosciences, Inc.
Live Q&A (ST4)
Amin Khan
Favorite
Kolivand, Faramarz
PDA Web Developerrrrrrrrrrrr
Faramarz test presentationsssssss
Faramarz Kolivand
Favorite
Faramarz test session
Faramarz Kolivand
Favorite
Koo, Lily
U.S. FDA
Live Q&A (C1)
Lily Koo
Favorite
Kreil, Thomas
Takeda Manufacturing Austria AG
Live Q&A (B3)
Thomas Kreil
Favorite
Quality Considerations and Verification of SARS-CoV-2 Safety Margins
Thomas Kreil
Favorite
Kuiper, Suzanne
Lighthouse Instruments
3: A Science-Based Approach to APS: Using Headspace Analysis for Automated Analytical Media Fill Inspection
Suzanne Kuiper
Favorite
3: A Science-Based Approach to APS: Using Headspace Analysis for Automated Analytical Media Fill Inspection
Suzanne Kuiper
Favorite
L
Labruto, Mike
University of Pennsylvania/Gene Therapy Program
C4: Moving Quality to the Next Level: "What Would it Take?"
Mike Labruto
Favorite
Live Q&A (C4)
Mike Labruto
Favorite
Langille, Stephen
ValSource
Live Q&A (ST3)
Stephen Langille
Favorite
Lastro, Michele
Regeneron Pharmaceuticals, Inc.
From Benchtop to BLA in Record Time: A Case Study
Michele Lastro
Favorite
Live Q&A (C2)
Michele Lastro
Favorite
Lee, Sau (Larry)
U.S. FDA
Live Q&A (C1)
Sau (Larry) Lee
Favorite
Lucia, Matthew
U.S. FDA
Live Q&A (P5)
Matthew Lucia
Favorite
Lyons, Nicholas
U.S. FDA
Live Q&A (P4)
Nicholas Lyons
Favorite
M
Markovic, Ingrid
U.S. FDA
C1: Holistic Capacity Planning: Best Practices and Lessons Learned from New Therapeutic Modalities
Ingrid Markovic
Favorite
Live Q&A (C1)
Ingrid Markovic
Favorite
Marks, Peter
U.S. FDA
Bringing Bespoke Therapeutics into Being
Peter Marks
Favorite
CBER Updates
Peter Marks
Favorite
Live Q&A (P5)
Peter Marks
Favorite
Live Q&A (P6)
Peter Marks
Favorite
McMeekin, Judith
U.S. FDA
Live Q&A (P5)
Judith McMeekin
Favorite
ORA Updates
Judith McMeekin
Favorite
McShane, John
Lachman Consultant Services, Inc.
Greenfield Site Biologic Drug Substance Licensure Preparation
John McShane
Favorite
Live Q&A (B2)
John McShane
Favorite
Mendoza, Melissa
U.S. FDA
CBER Compliance Updates
Melissa Mendoza
Favorite
Live Q&A (P3)
Melissa Mendoza
Favorite
Meng, Jeffrey
U.S. FDA
Live Q&A (A4)
Jeffrey Meng
Favorite
Montgomery, Frank
AstraZeneca
Implementation of ICH Q12
Frank Montgomery
Favorite
Live Q&A (B4)
Frank Montgomery
Favorite
N
Newcombe-Dierl, Lisa
Amgen Inc.
Effective CAPA Practices As A Competitive Advantage
Lisa Newcombe-Dierl
Favorite
Live Q&A (A1)
Lisa Newcombe-Dierl
Favorite
Nosal, Roger
Pfizer
Live Q&A (C1)
Roger Nosal
Favorite
mRNA Vaccines: A Paradigm Shift for Product Development & Manufacturing Capacity
Roger Nosal
Favorite
O
O'Donnell, Kevin
Health Products Regulatory Authority
Live Q&A (B4)
Kevin O'Donnell
Favorite
Quality Risk Management: An Update on the Ongoing Revision of ICH Q9
Kevin O'Donnell
Favorite
O'Sullivan, Pat
Sanofi
Live Q&A (B1)
Pat O'Sullivan
Favorite
Supply Chain Collaboration during a Pandemic
Pat O'Sullivan
Favorite
P
Pfeiler, Erika
U.S. FDA
Live Q&A (A2)
Erika Pfeiler
Favorite
The Complex: Science, Policy, and Case Studies of the Burkholderia Cepacia Complex in Aqueous Nonsterile Drugs
Erika Pfeiler
Favorite
Piepoli, Michele
Johnson & Johnson
Creating and Sustaining a Quality Mindset
Michele Piepoli
Favorite
Live Q&A (A3)
Michele Piepoli
Favorite
Pitts, Simone
U.S. FDA
Live Q&A (B5)
Simone Pitts
Favorite
Sterile Drug Hot Topics
Simone Pitts
Favorite
Plumb, Laura
Bionique Testing Laboratories
2: An Evaluation of Comparability Between an Alternative NAT Method Using Multiplex PCR and the Compendial USP <63> Culture-Based Method
Laura Plumb
Favorite
2: An Evaluation of Comparability Between an Alternative NAT Method Using Multiplex PCR and the Compendial USP <63> Culture-Based Method
Laura Plumb
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Polarine, James
STERIS Corporation
1: A Disinfectant Field Trial that Meets Annex I Guidance
James Polarine
Favorite
1: A Disinfectant Field Trial that Meets Annex I Guidance
James Polarine
Favorite
Porte, Quallyna
U.S. FDA
Inspection-Based Live Q&A
Quallyna Porte
Favorite
Inspection-Based Panel Discussion
Quallyna Porte
Favorite
Q
Qian, Keduo
U.S. FDA
B2: Supplier Oversight
Keduo Qian
Favorite
Live Q&A (B2)
Keduo Qian
Favorite
R
Ramanadham, Mahesh
U.S. FDA
Live Q&A (B1)
Mahesh Ramanadham
Favorite
Live Q&A (B4)
Mahesh Ramanadham
Favorite
Supply Chain and Inspections during the Public Health Emergency (PHE)
Mahesh Ramanadham
Favorite
Ramnarine, Emabelle
Boehringer Ingelheim
Live Q&A (A1)
Emabelle Ramnarine
Favorite
Managing Investigations with Supply Chain Partners Using a QRM Mindset
Emabelle Ramnarine
Favorite
Restrepo, Sabrina
Merck & Co., Inc.
Live Q&A (ST4)
Sabrina Restrepo
Favorite
Strategies for Vaccines Development and Lifecycle Management: What we are advocating for
Sabrina Restrepo
Favorite
Rexing, Bethany
Eli Lilly and Company
Live Q&A (C5)
Bethany Rexing
Favorite
Maximizing Benefit through Data Criticality Assessments and Process Data Flow Mapping
Bethany Rexing
Favorite
Rosa, Carmelo
U.S. FDA
Live Q&A (A3)
Carmelo Rosa
Favorite
Regulatory Perspective on Quality Systems
Carmelo Rosa
Favorite
Rozentsvayg, Abriana
Pfizer
Mitigating Risk to Container Closure Integrity of a COVID-19 Vaccine Product during Ultra-Cold Chain Storage and Distribution
Abriana Rozentsvayg
Favorite
S
Santillan, David
Lonza
4: A Comparative Analysis of Absorbance-Based Endotoxin Testing Using Different Microplate Readers
David Santillan
Favorite
Schniepp, Susan
Regulatory Compliance Associates Inc.
Case Study: Aging Facilities
Susan Schniepp
Favorite
Live Q&A (A5)
Susan Schniepp
Favorite
Live Q&A (P5)
Susan Schniepp
Favorite
Live Q&A (ST1)
Susan Schniepp
Favorite
Plenary 5: Center Updates
Susan Schniepp
Favorite
Special Topic 1: Deep Cold Storage
Susan Schniepp
Favorite
Schultz, Kimberly
U.S. FDA
Capacity Considerations for Cell & Gene Therapy Products
Kimberly Schultz
Favorite
Live Q&A (C1)
Kimberly Schultz
Favorite
Seymour, Melissa
Biogen
Covid-19 Industry Perspective: Practical Challenges and Transformations
Melissa Seymour
Favorite
Live Q&A (P2)
Melissa Seymour
Favorite
Simamora, Pahala
U.S. FDA
A2: Non-Sterile Drug Products: Microbial Risks
Pahala Simamora
Favorite
Live Q&A (A2)
Pahala Simamora
Favorite
Smith, Derek
U.S. FDA
Review-Based Live Q&A
Derek Smith
Favorite
Review-Based Panel Discussion
Derek Smith
Favorite
Solomon, Steven
U.S. FDA
CVM Updates
Steven Solomon
Favorite
T
Thakur, CDR Emily
U.S. FDA
Live Q&A (P2)
CDR Emily Thakur
Favorite
Throckmorton, Douglas
U.S. FDA
CDER Updates
Douglas Throckmorton
Favorite
Live Q&A (P5)
Douglas Throckmorton
Favorite
Tong, Weida
U.S. FDA
Artificial Intelligence for Regulatory Science Research
Weida Tong
Favorite
Live Q&A (ST5)
Weida Tong
Favorite
V
Viehmann, Alex
U.S. FDA
Live Q&A (ST2)
Alex Viehmann
Favorite
QMM Pilot Status and Future QMM/Metric Plans
Alex Viehmann
Favorite
Violand, Nicholas
U.S. FDA
Considerations for Adopting Modern Technologies
Nicholas Violand
Favorite
Live Q&A (C3)
Nicholas Violand
Favorite
W
Weber, James
Eli Lilly and Company
Live Q&A (C3)
James Weber
Favorite
Robotics and BIometrics Initiatives in Drug Product Manufacturing
James Weber
Favorite
Whelan, Valerie
Thermo Fisher Scientific
Closing Remarks
Valerie Whelan
Favorite
Live Q&A (P2)
Valerie Whelan
Favorite
Live Q&A (ST4)
Valerie Whelan
Favorite
Plenary 2: Emerging Stronger through Collaboration
Valerie Whelan
Favorite
Special Topic 4: PDA QbD Book and PDA Vaccine Development Lifecycle Technical Report
Valerie Whelan
Favorite
Welcome and Opening Remarks from PDA Leadership and Conference Co-Chairs
Valerie Whelan
Favorite
Wolton, David
Takeda
Facilitating Deployment of Autonomous Mobile Robotics (AMRs)
David Wolton
Favorite
Live Q&A (C3)
David Wolton
Favorite
Wright, Glenn
PDA
Live Q&A (B5)
Glenn Wright
Favorite
Y
Yalamanchili, Ravi
Merck & Co., Inc.
Live Q&A (C4)
Ravi Yalamanchili
Favorite
ML-Based Quality
Ravi Yalamanchili
Favorite
Yip, Richmond
U.S. FDA
Inspection-Based Live Q&A
Richmond Yip
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Inspection-Based Panel Discussion
Richmond Yip
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