"Where Compliance meets Excellence"

News

Registration for the 2018 AGXPE Conference and exposition is now open! 

               

FROM ACADEMIA TO ACTION!

                           CALL FOR SPEAKERS

PRESENT!

Submit your Presentation Proposal on one or more of the topics below, or something you believe is relevant in today‘s regulatory environment, by May 15, 2018.   https://www.surveymonkey.com/r/AGXPE_SUBMIT

Receive a honorarium, if your Proposal is selected.

Note:  Commerical proposals promoting products and/or services will not be considered


All AGXPE members and seasoned professionals are encouraged to participate in the 2018 Annual AGXPE Conference and Expo!  Tracks and suggested topics are highlighted in the following table.

GXP

GCP

Good Clinical Practices

GLP

Good Laboratory Practices

GMP

Good Manufacturing Practices

GDP

Good

Documentation Practices

REGULATIONS, STANDARDS & GUIDELINES

EU regulations · MHRA· ICH guidelines · FDA regulations & guidelines · OSHA ·EPA·  DEA ·Medical Devices · Combination Products ·USP ·PICS · ISO ·DOT· Global Harmonization · PDMA· FTC·FSIS·USDA·NSF

COMPLIANCE

Data Integrity·Auditing · Systems Based Inspections ·  Risk Management · Key Performance Indicators · Investigations · TMF ·Quality by Design  · Root Cause Analysis · Human Error · Managing Inspections · Good Clinical Tetsing  ·  Challenges in an International Workplace  · Metrics · Hazard Analysis Critical Control Point (HACCP)  · Adverse Experience

TECHNOLOGY

IT Compliance Systems · Data Capture and Transfer Across the GXP Spectrum (Pre-clinical, Clinical, Manufacturing, Post-Marketing) · Document Management Systems · Packaging ·Labelling·Online Learning Systems

TRAINING

Learning Management Systems · Instructional Design · Curriculum Design · Effectiveness · Metrics  · Implementing Case Studies ·  Competency Assessment · Needs Analysis  · New Hire · Refresher · GMPs for Management · Knowledge Checks · Behavioral Change Management · SIGMA                

COMMUNICATION

Technical Writing · Presentation Skills · Corrective Action/Preventative Action Writing


  • Submit your Presentation Proposal on one or more of the above topics, or something you believe is relevant in today‘s regulatory environment, by May 15, 2018.










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