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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$2,599.00

Seminar One Registration

May 23-24, 2017, Franklin Lakes, NJ
(Registrations till March 30, 2017 - $2599)
(Registrations till April 20, 2017 - $2699)
(Registrations after April 20, 2017 - $2899)

$2,899.00

Seminar One Registration (With 2 Nights Stay)

May 23-24, 2017, Franklin Lakes, NJ




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.

Other Registration Option

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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.

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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

Sheraton Mahwah Hotel
1 International Blvd,
Mahwah, NJ 07495, USA
Tel: 201-529-1660

May 23-24, 2017

Special Offer

Special Offer for the attendees of this seminar

Rooms available at only $149 per night.

You must book by April 26th 2017.

Please note: Hotel rooms are limited and based on availability.

How to Reach

General Driving Directions:

Driving directions from Newark Liberty International Airport:
  • Follow the signs out of the airport for the New Jersey Turnpike/ I-95.
  • Take the turnpike to Exit 16W.
  • Take Route 3 West to Route 17 North and continue for approximately 18 miles.
  • Exit at Mountainside Avenue/Crossroads Boulevard/Sharp Plaza.

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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Local Attractions of Franklin Lakes, NJ

Franklin Lakes Nature Preserve

Franklin Lakes Nature Preserve

Franklin Lakes Nature Preserve is a 147 acre public nature reserve located mostly within Franklin Lakes, New Jersey, with a tiny portion extending into North Haledon, New Jersey. Situated between the First and Second ridges of the northern Watchung Mountains, the preserve occupies the site of the former Haledon Reservoir. Passive recreation opportunities include hiking, fishing, and bird watching. The 147 acre Franklin Lakes Nature Preserve sets aside 120 acres of land for public recreation, including 75 acres of water. Due to its location, the preserve features an unusual variety of terrain. Swamps and wetlands are extensive, visible in almost every section of the property.

High Mountain Park Preserve

High Mountain Park Preserve

High Mountain Park Preserve is a protected area of the Preakness Range of the Watchung Mountains. Established in 1993, it comprises 1,153 acres of woodlands and wetlands. It is one of the largest tracts of conserved land in northern New Jersey. It serves to protect nine ecological communities harboring 380 plant species, 18 of which are rare. The preserve contains geological points of interest, including a rare traprock basalt glade and rock shelters which have been determined to be sites of prehistoric human habitation. During the American Revolution, high points along the ridge were used as signaling posts. Hiking trails are maintained by the New York - New Jersey Trail Conference. The summit of High Mountain provides a spectacular view of New York City.

Lorrimer Sanctuary

Lorrimer Sanctuary

Lorrimer Sanctuary was bequeathed to the New Jersey Audubon Society by Ms. Lucine L. Lorrimer in 1956. The main house, parts of which date back to the late 1700's, is the present visitors' center and sanctuary office. The visitors' center has an exhibit and lecture room, winter bird feeding station, interpretive displays, hands-on exhibits, and a gift shop, the proceeds of which benefit the sanctuary. There is a self-guiding trail system that winds through the 14 acres of land. Much of the acreage is second-growth woods (mostly oak, maple, ash, and beech); and small stands of planted evergreens.

Parson Pond Park

Parson Pond Park

The new 84-acre Parsons Pond Park was officially dedicated recently. The park features two ponds, a recreation building, a lighted handball court, two baseball fields, basketball courts, tennis courts, and walking/hiking paths. The new park brings the borough’s parkland to 470 acres. The park has a significant trail network around the back and a good overlook from the top of a hill at the crest of a trail.

Campgaw Mountain

Campgaw Mountain

Campgaw Mountain is the northernmost ridge of the volcanically formed Watchung Mountains, straddling the border of Franklin Lakes, Oakland, and Mahwah in Bergen County, New Jersey. Located almost entirely within the bounds of Campgaw Mountain Reservation, the mountain offers numerous outdoor recreational opportunities, including the only ski slope in the Watchungs. Campgaw Mountain is commonly considered to be part of the greater Ramapo Mountains region, but the flora and geology of the mountain is quite different from the surrounding area and more closely resembles the nearby Preakness Range to the south.

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