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GMP and Validation Operations – A Technical and Inspirational Approach

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KENX Introduces Virtual Series for Staying Connected, Informed & Inspired

 

During this time of COVID-19 it is everyone’s responsibility to support the effort to stay connected, informed and inspired. Because of our global position, our remarkable industry possesses extensive knowledge, experience and wisdom that can, and will, be used to resolve this pandemic. Many of the solutions necessary to ease the devastation and suffering of this pandemic lie with each one of us and the contributions we continue to make within our workplace. We provide the equipment, medicines and protective gear necessary for the front line and their patients.

 

As part of the global effort to combat this pandemic, join several industry thought leaders as they provide stimulating presentations, coupled with focused tutorials, on a wide range of topics essential to both our collective fight against COVID-19 and business continuity. We cannot give up –this is the time to stay connected and make a difference where it matters most.

 

Some of the topics that will be presented include:

  • Enterprise-wide Quality Metrics
  • Lifecycle Process Validation and Process Optimization
  • Continuous Quality Improvement
  • Empowered Decision-making and Risk Prevention
  • Microbial Contamination Control
  • Cleaning Validation & Critical Cleaning Processes
  • Supply Chain Optimization

 

Contact KENX for more information on how to register for these seminars focused on business continuity and strengthening our collective effort against COVID-19.

Click Here to Register

 

 

Speakers

Carmen Medina, MPH, Ph.D. (c)

President, Precision Consultants, Inc., Coronado, CA, Former FDA Investigator

Carmen uses over 30 years of FDA experience to support an array of U.S. and international clients in their preparations for successful Pre-Approval Inspections and FDA GMP inspections. Ms. Medina routinely guides clients in a variety of compliance matters, such as responding to Warning Letters, managing consent decrees, and designing commercialization strategies and litigation support. Carmen Medina was a former Commissioned Officer in the United States Public Health Service and an FDA investigator, where she led an international group within Team Biologics and helped usher in the new medical device regulations - QSR. She has conducted over 1200 GCP, GMP and QSR inspections resulting in an array of regulatory and criminal actions. Ms. Medina, a graduate of the Columbia University School of Administrative Medicine and School of Public Health, is internationally renowned for her work with the biotech, pharmaceutical and medical device industries.