ComplianceOnline

Process Challenge Device Development for EO Sterilization

Instructor: Gerry O Dell
Product ID: 703443
  • Duration: 90 Min

recorded version

$229.00
1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Mar-2016

Training CD

$399.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

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Email: customercare@complianceonline.com

Read Frequently Asked Questions

This webinar will discuss the role of Process Challenge Devices (PCDs) both during ethylene oxide (EO) validation and during routine processing. It will explain the difference in requirements for PCD during both the processes.

Why Should You Attend:

Since Process Challenge Devices (PCDs) are used so commonly during both ethylene oxide (EO) validation and during routine processing, it is important to understand what the ultimate purpose of the PCD. Choosing the wrong PCD, i.e. one that is overly resistant, can result in additional cost and added time to the routine sterilization process. Whereas choosing the wrong PCD, i.e. one that is not resistant enough, can result in an inadequate sterilization process. While the former situation is undesirable for your business the latter situation can result in harm to the patient. This webinar will outline how to avoid both of these risks to your business.

Areas Covered in the Webinar:

  • What is the purpose of the PCD?
  • What makes an appropriate PCD?
  • Are the requirements for PCDs different during validation versus routine processing?
  • How can you ensure consistency in your PCDs?
  • How should you evaluate or compare PCDs?
  • When is requalification of PCDs required?

Who Will Benefit:

This webinar will provide valuable information to all companies that produce sterile products.

  • QA personnel
  • Validation specialists
  • Manufacturing personnel involved in sterilization
  • R&D specialists

Instructor Profile:

Gerry O'Dell, is Owner and President of Gerry O'Dell Consulting, a consulting firm based in the United States with medical device and pharmaceutical clients around the world. Gerry O'Dell Consulting works to assist companies to comply with requirements to assure that their product is sterile at all stages of the development and manufacturing process. Prior to starting Gerry O'Dell Consulting in 1998, she worked for Johnson & Johnson as a Manager of Laboratory & Sterilization Services which managed the sterilization program for J&J Medical in addition to providing laboratory testing services to several J&J companies. She holds both a Bachelor and Master of Science degree in Microbiology from the University of South Florida and has over thirty years of experience in the medical device industry.

Topic Background:

Process challenge devices (PCDs) are used in the validation process for most types of sterilization. Published guidance is available for PCDs related to moist heat sterilization but the guidance for PCDs to be used for ethylene oxide (EO) sterilization is limited.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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