Course Content to Cover:
1. Introduction: The European view regarding aspects of Biological Safety
2. The TSE Directive 2003/32/EC and its impact for the assessment of material of animal origin
3. ISO 22442 series: New developments and important changes
4. Part 1- gap analysis
5. Part 2 - gap analysis
6. Part 3 - gap analysis
7. Discussion of open questions

Who Should Attend:
Professionals involved in Biological Safety, Regulatory Affairs, Research & Development, Quality Assurance with medical devices of animal material.

What You Will Learn:
Attendees will gain an understanding of European requirements for biological safety and of the three part ISO 22442 standard, including new developments and changes intended to provide requirements and guidance on risk management related to the hazards typical of medical devices manufactured utilizing animal tissues or derivatives. Background information will be provided on the assessment of animal origin material according to the TSE Directive 2003/32/EC.

About Our Subject Matter Experts:
Our instructor, Prof. Dr. rer. nat. Dr. med. habil. Sabine Kloth is an expert with medical devices utilizing biological material such as material of animal origin and human blood or its derivatives.

Since 2004, Sabine Kloth has acted as Professor for Anatomy at the University of Regensburg, Germany. The main focus of her current lectures is on Regenerative Medicine.

Her scientific background and main research interests include: Kidney organogenesis and regulation of blood vessel formation.

Since 2004 Professor Kloth has been affiliated with TÜV SÜD Product Service GmbH as Senior Product Specialist for Medical Devices Utilizing Material of Animal Origin. She is responsible for consultation procedures including TSE-consultation acc. the Directive 2003/32/EC and for consultations for medical devices including human blood or its derivatives.

Professor Kloth is a member of the TSE/BSE Working Group of the EU Commission, and member of ISO standardization committees with focus on Biological Safety and Cell-Based Medical Products. She is convenor of Working Group 1 of ISO TC194 SC1 with the main topic of risk management for biological materials.

Before joining TÜV SÜD Product Service GmbH Professor Kloth was CSO in a tissue engineering company aiming to produce implantable autologous blood vessels in vitro.

Lunch and training materials will be provided.

Hotel Information
This one-day training will be held at The Hampton Inn, Shoreview, MN. For more information on accomodations, contact Hampton Inn at 651-482-0402, and ask for the special room rate for TÜV SÜD America, or register online.

Scheduled Dates:

Cost: $299.00 (USD)

Time: 8:00 am -5:00 pm CST

Questions? contact:

Cancellation Policy