September Virtual Meeting Program

TRACK 1

Session A - EPA | 10:30 am-12:00 pm
A-1:  OECD GLPs, EPA GLPs and MAD Agreements - Kanthasamy Karunanandaa, Eva Haszcz, Kim Watson
Session Chair: Kim Watson

Break for Lunch with Exhibitors and Posters | 12:00 - 1:30 pm

Session D | 1:30-3:00 pm
D-1:  System-focused vs. Process-oriented CSV Audits: Fish your Data! – Can you Catch it? - René Kasan, Manu Reddy
D-2:  Data Obtained from Sources other than Traditional Clinical Trials from GCP Perspective - Kassa Ayalew, FDA
Session Chair: Johanna Wilson

Attended Poster Session & Break | 3:00-3:30 pm

Session G - BCSS | 3:30 - 5:00 pm
G-1:  Off the Beaten Path: Transitioning from a Quality Auditor to Quality Management - Robyn Durr-Henry
G-2:  Hosting a Remote US FDA Inspection:  The Expectations, Challenges, and Future Implications - Alia Legaux
G-3:  How is Quality Assurance Affected by the Advancement of Technologies? - Joseph Franchetti
Session Chair: Lori Wright

TRACK 2

Session B - PV | 10:30 am-12:00 pm
B-1:  Pharmacovigilance Auditing - The Basics, The Players, and The Challenges - Andrea Stark, Milind Nadgouda, Sarah Mills 
Session Chair: Cheryl Crain

Break for Lunch with Exhibitors and Posters | 12:00 - 1:30 pm

Session E - Data Integrity | 1:30-3:00 pm
E-1:  Buck Rogers and Training in the 25th Century - Timothy Kuhn, Randy Basinger 
Session Chair: Deborah Randell-Hlubek

Attended Poster Session & Break | 3:00-3:30 pm

Session H - GLP | 3:30 - 5:00 pm
H-1:  Is this a deviation? Deep Thoughts… - Megan Lawhead, Lindsay Nolan, R. Kelvin Mentzer, Carrie James, Deanna Talerico, Joshua Hittle
Session Chair: Megan Lawhead

TRACK 3 - COVID-19/Other

Session C | 10:30 am-12:00 pm
C-1:  The FDA Virtually Knocks on the Door and Tips for Hosting Remote Audits - David Schumacher
C-2:  Electronic Signatures In The Age Of A Pandemic - Carrie Logan
C-3:  Remote Inspections - Timothy Valley
Session Chair: Kim Frazier

Break for Lunch with Exhibitors and Posters | 12:00 - 1:30 pm

Session F | 1:30-3:00 pm
F-1:   Listening Session: Diversity, Inclusion, and Belonging - Gary Smith and Anne Veator, IVY Planning Group
Session Chair: Beth Moulaison

Attended Poster Session & Break | 3:00-3:30 pm

Session I | 3:30 - 5:00 pm
I-1:  Maintaining the Validated State of your Equipment and Processes During the COVID-19 Pandemic to Ensure Continuous Product Supply - Gerardo Gomez
I-2:  Expansion of UTMB/FDA Education Collaboration: Data Quality and Integrity in Clinical Trials Involving High Consequence Pathogens - Melissa Eitzen
I-3:  Data Integrity Validation — A new approach - Richard Siconolfi
Session Chair: Theresa Donegan

TRACK 1

Session J | 8:30-10:00 am
J-1:  Test Article Characterizations and GLP Inspectional Findings - Anne Johnson, FDA
J-2:  OECD – What You Need to Know - Eric Pittman, FDA
J-3:  An Update on the FDA Pathology Peer Review Guidance - Mark Seaton, FDA
Session Chair: Robin Guy

Break with Exhibitors and Posters | 10:00-10:30 am

Session M | 10:30 am-12:00 pm
M-1:  Overcoming Manufacturing Weaknesses in the Wake of COVID-19 - Terrance Holbrook
M-2:  Aspiring to be an Insightful QA Professional - Greg Furrow, Barb Munch
Session Chair: Lori Wright

Break for Lunch with Exhibitors and Posters | 12:00 - 1:30 pm

Session P - IT Compliance | 1:30-3:00 pm
P-1:  CVIC’s Crystal Ball Predicted the 2020 Landscape? - Richard Siconolfi, Stacey Blackmer
P-2:  Quality Assurance Surfing the Tsunami of Technological Advances - Stacey Blackmer, Richard Siconolfi
P-3:  Big Data, Data Analytics, and Data Information Platforms - Johanna Wilson
Session Chair: Barb Munch

TRACK 2

Session K - GCP | 8:30-10:00 am
K-2:  A PV Auditor’s Guide to Navigating Risk Management and Minimization Activities: Charting a Course for Success - Penelope Przekop
K-3:  Practical Risk Management for GCP Studies - Denise Lacey
Session Chair: TBA

Break with Exhibitors and Posters | 10:00-10:30 am

Session N - GLP/Med Device | 10:30 am-12:00 pm
N-1:  Playing with Organs: Auditing Necropsy and Histology - Barbara Munch
N-2:  Digital Pathology within the Regulatory Environment - Elizabeth Neyens
N-3:  Pathology and Medical Devices in GLP Studies: A Comprehensive approach - Elizabeth Neyens
Session Chair: Robin Guy

Break for Lunch with Exhibitors and Posters | 12:00 - 1:30 pm

Session Q - Data Integrity | 1:30-3:00 pm
Q-2:  Data, data everywhere, but can integrity be found? - Randall Basinger
Q-3:  Data Integrity At The Bench – How Fostering A Positive Quality Culture Is Essential In A Discovery Environment - Gowri Somayaji
Q-1:  Management Challenges in Implementing a Successful Data Integrity Program - Joseph Franchetti
Session Chair: Deborah Randall-Hlubek

TRACK 3 - COVID-19/Other

Session L | 8:30-10:00 am
L-1:  What in the World is GIVIMP? - Amanda Ulrey
L-2:  When Research is Thrown a Curve Ball- GCP Concerns in the Era of COVID-19 - Cynthia Kleppinger, FDA
Session Chair: Cheryl McCarthy

Break with Exhibitors and Posters | 10:00-10:30 am

Session O | 10:30 am-12:00 pm
O-1:  Business Resilience and Embracing Technology during COVID 19 – The Good, The Bad and the unacceptable - Milind Nadgouda
O-2:  The Art of Remote Auditing: A Practical Guide - Chandra Gordon
Session Chair: Thomas Purdue

Break for Lunch with Exhibitors and Posters | 12:00 - 1:30 pm

Session R | 1:30-3:00 pm
R-1:  Managing Fear - Kathryn Hackett-Fields
R-2:  Quality Risk Management Not an Option, But A Mindset, What Are We Learning During COVID-19 - Sam Sather
R-3:  Remote Operations and Maintaining HIPAA, GDPR, GCP, and COVID-19 - Sam Sather
Session Chair: MaryEllen Lander