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2024 Tampa Conference Presentations

2019 Spring Meeting - Merck

Quality Management & Oversight - Lifecycle of a Sponsor/Vendor Relationship - Micki Blair - Merck

Quality by Design - Build Quality into Clinical Trial to Proactively Identify & Mitigate Risks -  Reetu Dandora & Sharon Reinhard - Merck

Data Integrity goes to Court - Compliance Architects - John "Jack" Garvey - email Jack and he will come present for you and your team rather than share presentation online - john.garvey@compliancearchitects.com



2016 AGXPE Conference & Expo

Attendee List

  1. FDA-BIZJAK
  2. FDA-CALLAHAN
  3. BOYLE
  4. COARSE-CULLEN
  5. DEKEYSER
  6. DUNCAN
  7. FOX1
  8. FOX2
  9. GARVEY1
  10. GARVEY2
  11. KIBBEY
  12. KRENC
  13. LEWIS
  14. MCGINN1
  15. MCGINN2
  16. PADFIELD1
  17. PADFIELD2
  18. PETELINKAR
  19. RANIERI
  20. SBALESTA
  21. SHIKE



May 13, 2016 Chapter Meeting

Thank you to all of our members who were able to attend our third chapter meeting.  Please find the presentations from our meeting below.

agxpe Spring Meeting Friday May 13th, 2016.pdf

AGXPE-TransCelerate Update.pdf

Data Integrity_Management.pdf

SOPs GMP GLP GCP WO Graphics.pdf

Why Validate rev2.pdf

February 19, 2016 Chapter Meeting

Thank you to all of our members who were able to attend our second chapter meeting.  Please find the presentations from our meeting below.

AGXPE Meeting 02_19_2016_minutes.pdf

AGXPE Feb 2016 meeting attendance sheet.pdf

Achieving and Maintaining ISO Certification .pdf

GMP - Serialization Operator Readiness.pdf

GLP Overview Training Based on 21CFR Part 58.pdf

Emerging Inspection Trends at FDA.pdf

AGXPE CONFERENCE & EXPO 2015

Thank you to all of our members who were able to attend our first annual Conference & Expo.  Please find the presentations from our conference below.

Click here for Conference Presenters and Attendees Contact List

Day 1 Sept 28, 2015 

Combination Product Requirements 21 CFR Part 204

Speed Training GXP Exercise

SOP Creation Using SMEs

Embedding Quality and Managing Risk Throughout the Production Lifecycle

Training Effectiveness and 21 CFR 211.25

Lab Analyst Training and Certification Program

Training Needs Analysis


Day 2 Sept 29, 2015 

E-Records and E-Signatures

USP Standards

REMS

Global Identification of Medical Products

QbD Taguchi Methods

Medical Device Quality System Registration

Global Substance Registration

Why Aren't Our Employees Engaged?

OJT for GMP Cell Based Assay


Day 3 Sept 30, 2015 

The Supplement Regulation Revolution

Learning Management Systems Basics

Preparing for Audits of Vendors and Suppliers

Assessment Technologies and Their Applications

Regulatory Updates

Convenience Store Learner


May 15, 2015 Meeting

Thank you to all of our members who were able to attend our first meeting.  It was a great start to a long future ahead!

Please find the information and presentations from our meeting below.  

AGXPE Meeting 5_15_15_minutes.pdf 

AGXPE meeting attendance May 15 2015.pdf  

QBD Vs Design Control- 05-14.pdf

Speed Training GMP Exercise.pdf

Training Effectiveness and 21CFR Part 211.25.pdf

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