Association for GXP Excellence (AGXPE)

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2024 AGXPE Mid-Atlantic Chapter Fall Meeting - November 8, 2024

2024 AGXPE Conference Presentations - April 15-17,2024

2024 AGXPE Mid-Atlantic Chapter Winter Meeting - February 23, 2024

2024 Winter Meeting Attendance List
Engaging cGMP Learners - Manny Veloso & Rosa Melton
Learning-Business Partnership: From Taking Orders to Focusing on Learning Outcomes - John Constantine

2023 AGXPE Mid-Atlantic Chapter Fall Meeting - November 3, 2023

2023 Fall Meeting Attendance List
A Successful Data Management Quality Program - Becky Altmann

2023 AGXPE Mid-Atlantic Chapter Spring Meeting - May 5, 2023

2023 Spring Meeting Attendance List
Audit Basics: Interviewing & Data Analysis - Dr. Betsy Macht
Magic Ball Exercise Instructions - Manny Veloso & Rosa Melton

2023 AGXPE Mid-Atlantic Chapter Winter Meeting - January 27, 2023

2022 AGXPE Mid-Atlantic Chapter Fall Meeting - September 16, 2022

2022 AGXPE Conference and Expo - San Antonio, TX - May1-4, 2022

Monday, May 2

Tuesday, May 3

Wednesday, May 4

2019 East Coast Chapter Fall Meeting (Raritan Valley Community College) - November 1, 2019

Chapter Meeting Attendance Sheet

1 Minute Story – Get you message out there and make it stick! - Jesus Rivera

Four Faces of Compliance Training (Training Status, Validated Systems, Quality Content, Role-Based assignments) - John Constantine and Kent Malmros

Regulatory Inspection Prep - Maryann Fox

2018 AGXPE Conference and Expo - Cambridge, MA - October 28-31, 2018

Day 1

The Happiness Advantage: Bringing the Research to Life at Work Keynote Speaker: Devin C. Hughes

Strategies to Build Resilience and Avoid Change Fatigue Juliet Hart

Roche Biometrics Training Strategy - Scaling to Meet the Needs of the Business Christopher O’Le

Regulatory Convergence: Bringing Academia, Industry and Regulators Together Jared Auclair

Data-driven Learning Design Lori Niles-Hofmann

SOP Simplification Through a Principles based Approach Regina Neubauer Alice Savoca

Revamping The Vendor Qualification Process For Clinical Stage Outsourcing Laurie Halloran

Building a Positive Team - Helping Your People Be Happy and Engaged Devin C. Hughes Tammy Cullen

Handling Challenging Situations During FDA Inspections with Grace Under Pressure. Kim Mejia

System Validation -- Different Approaches to Interface Validation Robert Migliore

Stop the Stress and Present Your Best Denise Simpson

Day 2

Risk-based Thinking and Risk Management: Where are we in 2018? General Session Speaker: James Vesper

GXP Best Practices: How to be Even More Compliant Michelle Durcholz

Narrative Medicine: Innovative Techniques for Including the Voice of the Patient in Drug Development Jesus Rivera

Incorporating Lean Principles into an Approach to Rapid Content Development Joshua Gilliam

Keeping Companies Safe: Best Practices in Communications Surveillance from Other Regulated Industries Anish Parikh Kathleen Hamann

2018 – Inspection Trends, Updates, and Activities FDA Guest Speaker: Karen Archdeacon

Clinical Trials: Reduce risk and improve outcomes in the most costly aspect of new drug development Rich Lanchantin

Revamping Learning and Development with AI Giselle Mota

Keep it Simple! 5 Simple Rules of Explanation Andrea Acosta

Day 3

Handling Challenging Situations During FDA Inspections with Grace Under Pressure. Kim Mejia

System Validation -- Different Approaches to Interface Validation Robert Migliore

Stop the Stress and Present Your Best Denise Simpson

What's the Problem with Procedures? James Vesper

Summer Mtg June 2018

Spring Mtg March 2018 DSI

Case study: Ensuring eTMF compliance by moving from passive to active eTMF - Jamie Toth, Director, TMF Operations, Daiichi Sankyo

Bad SOPs = Bad Training: Garbage In, Garbage Out - Mike Esposito, Principle, TrainReach

An Update on ICHE6(r2) and ICH E8 and its impact on pharmaceutical companies - Tim Urschel, Head of Quality Operations and Planning, QA - Daiichi Sankyo

Review of Research Misconduct – through the years Terry McGinn & John Lewis

Fall Mtg November 2017 BMS

Data Integrity: Current Trends and Observations - Joseph Delfs - BMS

Developing Training for the Modern Learner - Kathleen Chamas and Linda Olivola BMS

How Proper Planning, Execution and Communication are Essential to Compliant GXPS - Joe Homan -Edspire

Using Micro-Learning to Reinforce Learning - Julet Hart

3 Strategies for Preserving Expertise - Peggy Salvatore

Association for GxP Excellence (AGxPE)

338 Buckingham Circle

Lower Salford, PA 19438

267.664.0157

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