ComplianceOnline

Course "Radiation Sterilization of Medical Products - Beyond the Basics" has been pre-approved by RAPS as eligible for up to 10 credits towards a participant's RAC recertification upon full completion.

This two day highly interactive course will cover all aspects of radiation sterilization validation, materials selection and processing implementation. This workshop has been designed to help attendees learn the ins and outs of all the radiation modalities, materials selection, and validation of the sterilization process per ISO 11137.

Additionally, 483 case studies will explore how to avoid the operational and legal issues that arise from nonconformance with regulators (FDA) and auditors.

Learning Objectives:

Upon completing this course on radiation sterilization, participants will:

  • Understand how to select product polymer materials for optimal product performance after radiation sterilization processing.
  • Know how to complete an optimal validation test design – inclusive of dose, dosimetry, sample size, accelerated ageing, ASTM standards, and thermal analysis.
  • Understand the effect of product design and assembly on bioburden, product safety and the success in executing the validation journey.
  • Understand all the foundations of a successful radiation sterilization program – materials, bioburden, validation, maintenance of validation.
  • Understand the impacts of all regulatory guidances on the radiation sterilization process.
  • Perform risk assessments effectively.
  • Understand where companies miss the mark in triggering, investigating and executing bioburden action levels and quarterly sterilization audits.
Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Who will Benefit:

This course is designed for medical device, biologic products, and pharmaceutical professionals who desire to get a complete understanding of the validation and use of radiation sterilization for their products. Following personnel will benefit from the course:

  • Senior quality managers
  • Sterilization managers
  • Quality professionals
  • Regulatory and Compliance professionals
  • Production supervisors
  • Manufacturing engineers
  • Production engineers
  • R&D engineers
  • Process owners
  • Quality engineers
  • Quality auditors
  • Medical affairs
  • Legal professionals
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Day 01(8:30 AM - 4:30 PM)
  • Registration Process: 8:30 AM – 9:00 AM
  • Session Start Time: 9:00 AM
  • Review of the radiation sterilization – modalities, history, strengths and limitations, terms, processing parameters.
    • History/Terms
    • Gamma, E-beam, X-ray – Is there a best choice?
    • Irradiator Designs and Processing Variables
    • Dose Rate and Distribution
    • Costs - Contractors, In-house Systems
  • Process Validation – Part I
    • History – Kilmer and Beyond
    • VD Max
    • Method 1
    • Method 2
    • Dose Audits
  • Materials Selection - Radiation Effects
    • Polymer Chemistry
    • AAMI - TIR # 17
      • Guidance Offered
    • Desirable/Undesirable Changes
      • Brittleness
      • Color Change
      • Odor
      • Hardness/Softness
      • Films, Adhesives
      • Crosslinking/Toughness
    • Stress – Out of Our Parts, Out of Our Lives
    • Supplier Databases and Websites
  • Process Validation – Part II
    • Bioburden Sampling
    • Sterility Testing
    • Family Grouping
    • Dose Audits
  • Product and Process Design – It all starts in R&D
    • Critical Decision Points
    • The Shotgun vs a Targeted Approach
    • Molding/Extrusion
    • 3D Printing
  • Bioburden Control and Epidemiology
    • Environmental Control
    • Control Levels
    • Bioburden Excursions
      • Typical Causes and How to Fix Them
      • People and Processes
  • Laboratory Issues
    • Choose a Good Partner and Save Time
    • Bioburden Counts – What does it Mean
      • Recovery Efficency
      • IDs – Where did that come from?
    • Sterility Failures
      • Typical Causes and How to Address Them
    • Planning Timeline
  • Basic Biocompatibility
Day 02(9:00 AM - 4:30 PM)
  • Packaging – Design & Materials
    • Regulatory Requirements
    • Design Latitude – Pouches, Trays, Materials
    • Materials to be Avoided
    • Breathability Requirements
  • ISO/AAMI/FDA Standards
    • ISO 11137-1
    • ISO 11137-2
    • ISO 11137-3
    • TIR #
    • FDA Guidance
  • Unique Materials
    • Polypropylene and Polyethylene
    • PC, Polyester
  • Product Validation
    • Dose Limits
    • Attributes – Design Limits
    • Accelerated Aging
  • Unique Aspects of Different Product Types
    • Biologics and Tissue Sterilization Validation and Processing
    • Pharmaceuticals
    • Combination Products Sterilization
  • Product Validation Summary/Planning… Planning…Planning
  • Learning from 483’s - Case Study Exercise from current FDA Warning Letters
  • The SAL Debate
    • 10-6, 10-3, 10-4
    • North America, Europe, ……
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Karl J. Hemmerich

Gerry O'Dell,
President, Gerry O'Dell Consulting

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. Prior to starting Gerry O'Dell Consulting, she worked for Johnson & Johnson Medical, Inc. as the 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. Before becoming a part of Johnson & Johnson Medical, Gerry was Manager of Sterilization Services at Critikon, Inc where she started as a Lab Technician. She holds both a Bachelor and Master of Science degree in Microbiology from the University of South Florida and has over twenty-nine years of experience in the medical device industry.

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$1,999.00

Seminar One Registration

February 1-2, 2018, Broomfield, CO




Early bird seats are limited and based on first-come, first-serve.

The registration fee includes: the workshop; all related course materials; morning tea/coffee, lunch and afternoon tea/coffee on both the days.


For discounts on multiple registrations, contact customer care at +1-888-717-2436.

Other Registration Option

By order form / PO#

Payment Mode

By Check -
Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

ComplianceOnline (MetricStream, Inc),
2479 East Bayshore Road Suite 260
Palo Alto, CA 94303
USA

By Wire -

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Terms & Conditions to Register for the Seminar/Conference/Event

Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ customercare@complianceonline.com

Payment:
Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and documents to carry to the seminar venue:
After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:
By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.

Location

Courtyard by Marriott - Boulder/Louisville
948 W. Dillon Road,Louisville,
Colorado, 80027, USA
Tel: 303-604-0007

February 1-2, 2018

How to Reach

General Driving Directions:

From Denver International Airport
  • Go West on Pena Blvd for approximately 4 miles. Merge with E470 tollway (exit 6B toward Fort Collins) and go north for 19 miles.
  • Take the Dillon exit going West for about 5 miles.
  • The Courtyard by Marriott will be on the left side of the street--right before reaching the McCaslin intersection.

Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. ComplianceOnline is not responsible for any inaccuracies in the same.

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We are pleased to offer several exhibitor, sponsorship and media partnership options designed to maximize your company's exposure and networking opportunities before, during and after the event.

Benefits of becoming a Sponsor/Exhibitor/Media Partner:

  • Logo on website, marketing email, branding materials & the registration booth
  • Exhibit Space
  • Free event pass
  • Speaking opportunity
  • Social media campaign

For more details and other sponsorship options at this event, please contact Event Manager: customercare@complianceonline.com or call: +1-650-238-9656

Media Partner:

Media Partner

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