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PDA Metro Chapter 14th Annual Chapter Day - Aseptic Processing: Quality by Design Event

: 2 May 2019

: Bridgewater, United States

Sector: Pharmaceutical

Type: Conference, Meeting


Overview

Many elements in an aseptic process assure product sterility. Consideration must be given to facility and primary engineering controls, employee training, equipment disinfection. Process simulations, environmental monitoring, and product testing, while important, are limited in their ability to assure product sterility. We have put together a full day of experts who will share their knowledge and experience of managing these critical control points.

 

Agenda

  • Sterility by Design - Presented by James Agalloco, Agalloco and Associates
  • Engineering Considerations in Cleanroom Design and Construction - Presented by Jim Wagner, CEC
  • Critical Points for Effective Training of Aseptic Technique - Presented by Eric Kastango, CEO, CriticalPoint Training
  • Process Simulations: Identify and Achieve Regulatory Compliance Requirements - Presented by Karen McCulloch, MMI Associates
  • Recent FDA Inspection Domestic and Global Trends, Findings & Warning Letters - Presented by FDA Speaker: Russell Gampion (2nd speaker to be announced)
  • Disinfection and Sterilization of Aseptic Processing Operations - Presented by Madison Hoal, EcoLab
  • Environmental Monitoring: Failures and Responses - Presented by Frank Settineri, Veracorp
  • Panel Discussion/Q&A

 

Find out more / register here:

Venue

Bridgewater
NJ
United States


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Monitoring of Biobur...
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Quality Control for ...