The Association for GXP Excellence (AGXPE) is pleased to hold this live Mid-Atlantic Chapter meeting at the home facility of one of our sponsors, UL Solutions - ComplianceWire® (101 Carnegie Center, Einstein Seminar Room, Princeton, NJ 08540). We invite you to join us at UL Solutions as we kick off our first in-person event of 2023.
The agenda will be as follows (all times are EST):
- 11:00AM – 11:30AM: Check-Ins, Registration
- 11:30AM – 11:45AM: Opening Remarks
- 11:45AM – 12:00PM: AGXPE Leadership Update
- 12:00PM – 1:00PM: Learning is an experience; everything else is just information - Nicole King, MBA (AstraZeneca)
- 1:00PM – 2:00PM: Lunch / Social / Raffle
- 2:00PM – 3:00PM: Current GXP Trends and Topics in Microbiology - Amy McDaniel, PhD (BMS)
- 3:00PM – 3:30PM: Closing Remarks
Community Give Back
AGXPE Mid-Atlantic Chapter Food Drive Flyer
In alignment with the AGXPE commitment to giving back to the communities where we operate, we will also be running a food drive at this event. AGXPE Mid-Atlantic Chapter Leadership will be collecting non-perishable food items for donation to Manna on Main Street, in Lansdale, PA. Manna on Main Street operates a food pantry and soup kitchen, as well as provides other important services to neighbors in need, and is committed to ending hunger in the North Penn region. Any non-perishable goods (on this list) that could be dropped off at the event would be greatly appreciated and help out needy families in these challenging times.
Event Speaker Bios:
Nicole King, MBA
Nicole King began working for AstraZeneca in 2018 as the Learning Lead for AZ’s Newark Delaware Supply Site. Previous to AstraZeneca, Nicole worked in Aerospace, specifically in Missile Defense for an Engineering and Production of Rocket Motors, and Missiles organization as the Lead Internal Auditor & Process Owner of the Compliance & Regulatory Training Program. Prior to Missile Defense, Nicole worked for Toyota and was a student of one of Toyota’s premier Lean Training Programs (Toyota Signature).
Since being with AstraZeneca, she’s been promoted twice and is now in the position of, and responsible for being the Global Process Owner of GXP Training within Operations and R&D; a position not previously in existence at AstraZeneca. The creation of the position demonstrates AstraZeneca’s understanding of the importance of and commitment of improvement of GXP training – both from a Regulatory perspective and the End User’s perspective.
Nicole is currently leading a Global Pilot and consequent BAU roll-out (GXT Education and Training Uplift Project – GETUP) aimed at removing all Read and Understands (SOPs, etc.) from GXP training and instead creating a modularized Just in Time (JIT) competency & multi-modality based training framework. Nicole has an M.B.A. in Executive Leadership and plans on continuing the journey to receive a Doctorate in Organizational Effectiveness and Learning. Nicole currently resides in Elkton Maryland with her husband and two daughters.
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Amy McDaniel, PhD
Amy McDaniel is the Senior Director of the Microbiology Center of Excellence at Bristol Myers Squibb. In this role, she leads harmonization of microbiology strategy and methods for small and large molecules, in process production material, drug substance, and final product. She is part of the Analytical Strategy and Operations Division in the Pharmaceutical Development Organization, responsible for the production of clinical material and transfer of analytical assays to the commercial manufacturing sites around the world. She is also responsible for new technology implementation for the Clinical Supply Organization at the New Brunswick, NJ site, and the cascade of the technology globally across the company.
Prior to joining BMS, Amy was a microbiology reviewer in CDER’s Office of Pharmaceutical Quality, Division of Microbiology Assessment, reviewing sterile small molecule filings for generic drugs. Prior to the FDA, Amy was in management roles at Pfizer for 17 years, which included QC Microbiology, Manufacturing Operations, Technical Operations, and Quality Assurance. She has authored multiple articles and book chapters and presented on technical topics in rapid and traditional microbiology. Amy holds a Ph.D. degree in Microbiology and Molecular Genetics from Rutgers University.
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