Zurich, Switzerland: +41 - 43 434 80 33   |   US: (510) 962-8903   |   support@traininng.com

Seminar Price Details

40
Days Left To REGISTER
Seminar Fee for One Delegate
Price : US$799.00

Register for 5 attendees
Price : US$3,995.00

Register for 10 attendees
Price : US$7,990.00



**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.
  • Course Description
  • Agenda
  • Price
  • Speaker
  • Venue

Overview

The course is designed to ensure attendees fully understand regulatory requirements for sterilization processes of medical devices and their validation.

Learning Objectives

  • Provide an overview on the sterilization methods for medical devices
  • Provide information on validation approach for different sterilization technologies 
  • Provide information on biocompatibility aspects related to sterilization
  • Understand requirements of production hygiene
  • Understand relationship between sterilization and sterile barrier, packaging validation and shelf life

Why you should attend

This one-day course will provide detailed information on specific aspects of the sterilization of medical devices.

Who Will Benefit

  • Top Management
  • Responsible persons for Design & Development, Engineering, Production & Quality Assurance
  • Quality & Regulatory Professionals
  • Management representatives, Internal and External Auditors 
  • Consultants

Agenda

Day 1 Schedule

09:00 - 10:30    Sterilization of medical devices

  • Regulatory requirements
  • Basic introduction on microbiological aspects
  • Hygienic concept, Laboratory testing and validation
  • Bioburden, EO residuals, endotoxins

10:30 - 10:45    coffee/ tea break

10:45 - 12:30    Validation of sterilization processes

  • Validation approach, documentation requirements
  • Validation of different sterilization procedures (ethylene oxid, irradiation)
  • Revalidation, change control

12:30 - 13:15    Lunch

13:15 - 15:00    Sterilization and biocompatibility

  • Material impact of sterilization procedures

15:00 - 15:30    coffee/ tea break

15:30 - 17:00    Sterilization aspects in ISO 13485:2016 and in new Medical Device Regulation

  • Safety and Performance requirements on sterilization

17:00 - 18:00    Questions and answers

Day 2 Schedule

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Group participations

Get fabulous discounts by participating in groups of two or more.

No Attendees Discount
1 2 Attendees 10% off
2 3 to 6 Attendees 20% off
3 7 to 10 Attendees 25% off
4 10+ Attendees 30% off

To avail the above group discounts, all the participants should register by making a single payment

Call our representative TODAY on +41 - 43 434 80 33 to have your seats confirmed!

Michael Rinck 

Independent consultant ,
MT Promedt Consulting GmbH


Michael Rinck An independent consultant with over 30 years of international experience in developing and implementing corporate strategies in the areas of quality systems and regulatory compliance for the health care industry. He combines strong experience in quality, compliance and regulations with a pragmatic approach at both operational and strategic level. Specific expertise in production of sterile disposables, biocompatibility (ISO 10993) and clinical evaluation, quality systems and regulatory affairs for medical devices, API’s and pharmaceuticals. Experience in international supplier audits, implementation of complaint handling, medical device vigilance, CAPA and change control systems. Strong experience in validation projects for ETO sterilization (ISO 11135), sterilization with irradiation (ISO 11137) and chemical sterilization (ISO 14937). Project activities included definition of validation strategies, writing validation project protocols and reports, coordination of validation activities and external laboratory testing as well as coordination with Notified Bodies.

Long year international project activities in Europe, USA and Asia in regulatory processes for certification of innovative medical devices including new biomaterials, combination product and devices with animal tissue. Expertise in management of regulatory affairs projects in the EU, USA and Asia including product registration. Product experiences are available in the areas of active implantable medical devices, orthopaedic implants, absorbable biomaterials, extracorporeal systems and immuno-apheresis technologies, cardiovascular products, drug eluting stents, hemotherapy systems and IVD products as well as sterile parenteral solutions for dialysis and infusion.

Dr. Rinck is a regulatory specialist with strong scientific background in microbiology possessing a Diploma and a Ph.D. in Microbiology from Technical University Berlin and a License in Pharmacy. He has conducted research in antimicrobial coating, biomaterials and sterilization technologies and developed and implemented these into routine manufacturing processes. Special areas of interest are toxicological evaluations of biomaterials and extractables/leachables process validation such as sterilization and aseptic filling as well as writing and editing expert reports and clinical evaluation reports

Venue

Location: Germany
Hotel: WILL BE ANNOUNCED SOON