ComplianceOnline

Sterilization Options for Challenging Products

Instructor: Gerry O Dell
Product ID: 701928
  • Duration: 60 Min

recorded version

$299.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Aug-2011

Training CD / USB Drive

$449.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-565-8542

Email: customercare@complianceonline.com

Read Frequently Asked Questions

Attend this webinar to understand various sterilization processes and their general compatibility to various types of challenging medical products.

Why Should You Attend:
Medical products are more complicated and have greater challenges for sterilization process than ever before. These products might include tissue-based products, combination products, devices with drug coatings, devices with batteries or equipped with integrated software, circuits or computer chips.

Each of these present their own challenges for sterilization starting with selecting a compatible process to developing the validation strategy and meeting the regulatory requirements for ensuring that the sterilization process is adequate for the medical product. Making a mistake can be costly not only in immediate costs but also in project delays and potentially in regulatory approval.

This presentation will review various sterilization processes and their general compatibility to various types of challenging medical products as well as some of the challenges that each of the various sterilization processes might present. In addition the methods that are available for validation will be addressed demonstrating how they may be applied to reduce the effects of the sterilization process.

Other methods such as aseptic processing and reduction of SAL will also be discussed along with their regulatory acceptance both in the United States and internationally.

Areas Covered in the Seminar:

  • What makes a medical product challenging for sterilization?
  • Challenges of radiation sterilization.
  • Challenges of ethylene oxide sterilization.
  • Challenges of moist or dry heat sterilization.
  • Challenges of novel sterilization methods.
  • Validation methods that are available.
  • Aseptic processing/reduction of SAL - is it an option?

Who Will Benefit:

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

  • QA personnel
  • Validation specialists
  • Manufacturing personnel involved in validations
  • 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. Her over 27 years of experience in all the major sterilization methods, microbiology, environmental control, laboratory compliance, failure investigation, has enabled Gerry to successfully consult to companies ranging from small start-up operations to Fortune 500 companies. She has also played a significant role in sterilization standards development for over 15 years through her association with the American Association for the Advancement of Medical Instrumentation (AAMI).

Follow us :
Upcoming In-person Seminars by EX-FDA OFFICIALS
FDA's Medical Device Software Regulation Strategy

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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