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Contamination Prevention and Control in Medical Devices - ASQ Biomedical NCDG September 27, 2017 Roundtable

ASQ Biomedical Division NCDG - Northern California Discussion Group

Wednesday, September 27, 2017 from 7:00 PM to 9:00 PM (PDT)

Contamination Prevention and Control in Medical...

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Ticket Type Sales End Price Fee Quantity
Online discounted registration
Register by SEP 26, 2017 11:59 PM to receive this discounted rate.
Sep 26, 2017 $30.00 $0.00
Student & Unemployed discounted online registration
Register by SEP 26, 2017 11:59 PM to receive this discounted rate.
Sep 26, 2017 $20.00 $0.00
SEP 27, 2017 Online & At Door   more info Not Started $40.00 $0.00

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Event Details

 

Wednesday, September 27, 7:00 to 9:00 pm

Topic:  Contamination Prevention and Control in Medical Devices

Though controls for medical device manufacturing are not as stringent as aseptically manufactured sterile products, cleanroom design, operations, maintenance, monitoring and control is crucial to meet product pre-sterilization bioburden.

Understanding cleanroom standards, cleanroom airflow, material and personal flows is useful in meeting set acceptance criteria as well as standards.

Particulate control in device manufacturing could be as crucial as microbial control, and particle sources if not identified and controlled through design and operations may lead to lost product.

This brief presentation will address

  • How to interpret the new ISO 14644-1 standard for cleanrooms and controlled environments
  • Cleanroom design and construction -interpreting ISO 14644-4
  • Understanding airflows in relation process-smoke studies a diagnostic tool
  • Particulate control and mitigation strategies
  • Best practices in gowning, IEST-RP- CC003 and cleanroom housekeeping and monitoring procedures, IEST-RP-CC018

  

Image result for morgan Polen, Microrite

Presenter: Morgan Polen

Cleanroom Consultant, Microrite, Inc.

Morgan Polen is Microrite’s subject matter expert on contamination control in cleanrooms. He has developed Investigative Smoke Study programs for Life Science cleanrooms to accurately document cleanroom air flow patterns for suitability to international standards and regulatory guidance. He is a member of ISO Technical Committee 209 (Cleanroom Standards ISO 14644) and on the Board of IEST. He has over 30 years of experience in diagnosing cleanroom contamination and monitoring issues in pharmaceutical, bio-pharmaceutical, medical device, electronic, aerospace and optical industries.

Moderator: George Marcel

Location: Stellartech Research Corporation, 560 Cottonwood Dr., Milpitas, CA 95035 

Food:  Snacks equivalent to a light meal and beverages are provided at each event at no additional cost. 

Email: To be added to or removed from our email list, contact George Marcel (gjmarcel@gmail.com).

Registration Link: ncdgsep2017.eventbrite.com

ONLY Check or Credit Card accepted at door

Questions:  For information about this session, contact George Marcel (gjmarcel@gmail.com)

Formal discussion and questions will end between 8:30 - 8:45 pm to allow time for networking after the roundtable presentation.

Materials: Handouts provided. Please limit distribution to immediate personal professional use only. 

_____________________________________________________

If you are unable to attend, you can still join us remotely via webinar link at no cost:

Note; Presentation Materials or RU credits not provided)

 Webinar link for September  Roundtable  - 

https://register.gotowebinar.com/register/7212310679415289345

 _______________________________________________________ 

 


Have questions about Contamination Prevention and Control in Medical Devices - ASQ Biomedical NCDG September 27, 2017 Roundtable ? Contact ASQ Biomedical Division NCDG - Northern California Discussion Group

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When & Where


Stellartech Research Corporation
560 Cottonwood Drive
Milpitas, CA 95035

Wednesday, September 27, 2017 from 7:00 PM to 9:00 PM (PDT)


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Organizer

ASQ Biomedical Division NCDG - Northern California Discussion Group

§The Northern California Discussion Group (NCDG) is the regional ASQ Biomedical Discussion Group.  The Biomedical Division is an industry specific Division of ASQ §  Our Vision  To be the leading authority on quality issues related to the Biomedical Community   Our Mission  To promote the awareness and the use of quality principles, concepts and technologies in the Biomedical Community   www.asq.org/biomed   The local discussion group has a Linked In group (https://www.linkedin.com/groups/1804635) and mailing list as noted above.

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Contamination Prevention and Control in Medical Devices - ASQ Biomedical NCDG September 27, 2017 Roundtable
Things to do in Milpitas, CA Seminar Science & Tech

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