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PDA West Coast Chapter Contamination Control Basics - Risk and Resolution Event

Jun 20, 2019
Brisbane, CA

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Science is no longer isolated; it is living across the life-cycle of the product/process within a Quality Management System. Poor cGMP conditions at a manufacturing facility can ultimately pose a life-threatening health risk to a patient.

The manufacturing of products for human use is subject to special requirements to minimize risks of microbiological, particulate and pyrogen contamination. The following key areas should be considered when assessing risk; these are typically assessed, controlled and monitored individually, but these many sources should be considered holistically.

A contamination control strategy should be implemented across the facility to assess the effectiveness of all the control and monitoring measures employed.

Topics Discussed:

  • Design of both the plant and process
  • Equipment and Facilities
  • Personnel
  • Raw Materials Control- including in-process controls
  • Product containers and closures
  • Vendor approval – such as key component suppliers, sterilization of components and single use systems, and services
  • Process risk assessment
  • Process validation
  • Preventative maintenance – maintaining equipment and premises (planned and unplanned maintenance) to a standard that will not add significant risk of contamination
  • Cleaning and disinfection
  • Monitoring systems - including an assessment of the feasibility of the introduction of scientifically sound, modern methods that optimize the detection of environmental contamination


    • 6:00 p.m. Registration/Networking Begins
    • 7:00 p.m. Complimentary Buffet Dinner
    • 7:45 p.m. PDA WCC Announcements
    • 8: 00 p.m. Presentation/Q&A
    • 9:00 p.m. Closing Remarks

Highlighted Speakers

Ziva Abraham
Ziva Abraham
Microrite, Inc.


Please read: PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

DoubleTree by Hilton Hotel San Francisco Airport North

5000 Sierra Point Parkway
Brisbane, CA


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