2-Days In-Person Seminar

Radiation Sterilization of Medical Products - Beyond the Basics

Martell Winters
Aug 24 - Aug 25 , 2017
Starting at

$2399

Premier price: $2279 (save 5%)

Single registration

Aug 24 - Aug 25 , 2017
Buy Now

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.

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
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, ……
Seminar (Price/Register)
Aug 24 - Aug 25 , 2017 (2 Days)

Single registration

Premier price: $2279 (save 5%)

Group of Six

Premier price: $10639 (save 5%)

Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar

Other Registration Option
  1. Download the Order Form
  2. Fill this form with attendee details & payment details
  3. Fax your PO to 1-888-883-7697 or,
  4. Email it to cs@compliance.world

Payment Mode

By Check -

Pay your check issued from the payee to "Redstone Learning Inc." (Our Parent Company) and mail the check to –
Compliance.world (Redstone Learning Inc.)
1180 Avenue of the Americas,
8th Floor, New York,
NY 10036

  Media Partners

If you wish to partner with us for this event

please contact us: partner or
call us: 1-866-978-0800

Media Partner Benefits

  • Logo and company data on the event website.
  • Logo on the conference material distributed during the conference.
  • Media Partner’s brochure distributed along with conference material.
  • Logo on all the mailings before and after the event.
  • 10% discount to media partner's subscribers.

Media Partner to do

  • Banner (min 728x90 or 468x60) on the Media Partner website.
  • Insertion of the event in the event calendar, both printed and/or online.
  • Announcement article of the conference on the Magazine and/or Website.
  • Dedicated email blast to all subscribers of Media Partner.
  • Article on the Magazine and/or Website after the conference.

  Sponsors

If you wish to partner with us for this event

please contact us: sponsor@compliance.world or
call us: 1-866-978-0800
Speaker: Martell Winters,

Martell Winters received a B.S. in microbiology with a minor in chemistry from Brigham Young University. Mr. Winters has been at Nelson Laboratories for 20 years and spent most of that time working in the Radiation Sterilization group, responsible for bioburden testing and radiation validation studies. His specialties include microbiological process validation and radiation sterilization of medical devices, allograft tissue and pharmaceutical products. He is currently a Senior Scientist for Nelson Laboratories.

Mr. Winters serves on many AAMI Sterilization Working Groups. He is also on the AAMI Sterilization Standards Committee and is the AAMI liaison to the AATB Standards Committee. In 1995 he received his Registered Microbiologist (RM) certification, and in 2001 his Specialist Microbiologist (SM) certification in consumer products and quality assurance microbiology from the U.S. National Registry of Microbiologists.


Toll Free

1-866-978-0800

Fax

1-888-883-7697