Compendium: GMP University | August 2018

Compendium: GMP University | August 2018

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Description

KENX’s GMP University took place August 21-23, 2018 in beautiful Philadelphia, PA! The event took a deep dive into Internal Audits and FDA Inspections, Quality Risk Management, and Change Control, and also offered case study, in-depth coverage on:

 

  • Regulatory intelligence – Stay up to speed on regulatory thinking
  • Know ICH guidelines and why you should care
  • Going beyond FMEA – QRM tools you should be using (but aren’t)
  • Creating custom risk tools/risk-based approaches
  • Presenting your QRM program to an inspector

 

  • Building and managing a program that is inspection ever-ready
  • Knowing the regulations, guidance and warning letters
  • Change control and configuration management
  • Handling deviations in change control processes
  • Performing a quality system gap assessment

 

  • Interpret and Respond to Regulatory Concerns
  • Dive into Hot Topics for Regulatory Inspections – Data Integrity, Metrics and QRM
  • Attend a Bio/Pharmaceutical Audit Management Boot Camp
  • See a Medical Device Single Audit Process (MDSAP) Manufacturer Case Study
  • Inspection Readiness – What It Mean and How Can You Achieve It

 

The compendium offers over 900 content-rich pages including SOPs, templates and master plans.

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