ComplianceOnline

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.

Learn from two of the foremost validation, materials, and operations leaders in the marketplace. The course instructors have decades of experience in microbiology, validation, operations on traditional as well as tissue/biologic and combination products. Save time and money by attending this course dedicated to increasing your knowledge in radiation sterilization.

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
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
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
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, ……
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Karl J. Hemmerich

Karl J. Hemmerich ,
President- Ageless Processing Technologies

Mr. Karl J. Hemmerich, President of Ageless Processing Technologies, has over 35 years of experience in medical device product design, development, manufacturing, and sterilization. He specializes in sterilization method selection and program development with emphasis on component material selection, process development and sterilization process validation. Karl has extensive experience in radiation sterilization with over 10 years in management of a gamma processing facility, as well as a technical resource for Customers with materials and dose related product issues. Karl made numerous presentations at Customer sales seminars, industry technical conferences and the FDA. Some of the subjects covered included radiation compatibility and selection of materials (i.e. radiation grade polypropylene), gamma processing, dosimetry, package design, validation test design, preventing part failure through enhancements in processing and product design, and accelerated aging.

In 2004 Medical Device and Diagnostics Industry selected Mr. Hemmerich as one of the 100 Most Notable People in the medical device industry. He holds numerous medical device patents and is a member of American Society of Mechanical Engineers, American Society for Quality Control and the Society of Plastics Engineers. He has written and presented papers on sterilization and materials selection for many corporations, universities and professional organizations, including MDDI, SPE, FDA, HIMA, & ASQC, and his paper on radiation effects on polymers published in Medical Device and Diagnostics magazine remains an industry standard (www.mddionline.com/article/polymer-materials-selection-radiation-sterilized-products ). He has taught courses in Radiation Sterilization of Medical Polymers and Preventing Plastic Part Failure through the College of Engineering, University of Wisconsin. He is a contributing member of the AAMI SWG96/ISO11137 “Radiation Materials Working Group” that developed Technical Information Report # 17 as the guidance for materials selection, qualification/validation test techniques and quality processing methods for all common sterilization methods. Mr. Hemmerich is Co-director of the Editorial Advisory Board for MDDI magazine where he offers forward looking guidance as well as technical review for state-of-the–art articles prior to publication.

Martell Winters

Martell Winters,
Senior Scientist - Nelson Laboratories

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.

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$2,399.00

Seminar One Registration

August 24-25, 2017, Scottsdale, AZ
(Registrations till June 10, 2017 - $2399)
(Registrations till July 10, 2017 - $2499)
(Registrations till August 5, 2017 - $2699)
(Registrations after August 5, 2017 - $2899)

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Special Group Discount Register for Six attendees

August 24-25, 2017, Scottsdale, AZ
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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.


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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

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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.

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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.

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Location:

Scottsdale, AZ
(Venue to be announced shortly)

August 24-25, 2017

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If you wish to sponsor this event please contact Cruise Webster: cwebster@complianceonline.com or call us: (207) 576-4173

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Local Attractions of Scottsdale, AZ

Phoenix Skyline

Phoenix Skyline

Downtown Phoenix offers something for everyone including, museums, performing arts venues and a thriving art scene as well as a large sports presence. Chase Field is home to the Arizona Diamondbacks and the US Airways Center is home to the Phoenix Suns, the Phoenix Mercury, the Arizona Rattlers and the Phoenix Roadrunners.

METRO Light Rail Transportation

METRO Light Rail Transportation

METRO is now open and operating with traffic in the cities of Phoenix, Tempe and Mesa. At any time of the day or night, you can find yourself near an operating light rail vehicle or a METRO train consisting of two or three vehicles connected together.

MLB Spring Training

MLB Spring Training

The Cactus League has been an Arizona tradition for over a half-century. What began as a two-team league in 1947 has grown to twelve Major League Baseball teams playing in seven cities throughout the state. The league's popularity is at an all-time high with games scheduled every day in March. The Cactus League offers baseball enthusiasts an excellent opportunity to enjoy their favorite teams in fan-friendly, state-of-the-art ballparks.

Arizona Sunset

Arizona Sunset

Be sure to bring your camera as the desert offers spectacular sunsets and beautiful scenery year round.

Red Rocks

Red Rocks

Red Rock State Park in Sedona (110 miles) is an open-sky theatre of fabulous rock formations. Sprawled across 286 unspoiled acres, this popular park is the perfect starting point for hiking, picnicking, bird watching and photography.

Cathedral Rock

Cathedral Rock

Cathedral Rock in Sedona is 110 miles away and offers a great hiking trail for the adventurous. Cathedral Rock, also known as 'Lovers', was thought to be created by the Great Spirit. A couple of lovers, who always argued, were asked by Him to look around at the beautiful surroundings and count their blessings. The couple was believed to never argue thereafter and stands in perfect harmony.

Camelback Mountain

Camelback Mountain

Camelback Mountain draws thousands of visitors with its sheer red sandstone cliffs and its telltale hump. Hiking to the top is not for beginning hikers -- the two summit trails are strenuous climbs over sometimes-tricky trails. Some easier trails allow close-up exploration around Camelback's base.

Montezuma Castle

Montezuma Castle

Located 90 miles north of Phoenix, you can marvel at the 1,000 year old legacy of the Sinagua as you explore the ruins at Montezuma Castle National Monument. A paved, 1/3 mile loop trail takes you through a tranquil sycamore glade and past the ancient cliff dwellings of a people surprisingly similar to us.

Prickly Pear Cactus

Prickly Pear Cactus

Prickly pear cactus are found in all of the deserts of the American Southwest, and are abundant in the mountains around Tucson and offer a beautiful site when they flower in the spring.

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