Medical Devices

Upcoming

2010

20/09/2010 Day Course	CRF design workshop Lecturer: Ms. Tali Azulay
24/10/2010 Day Course	Biosensors: Priciples & Applications Lecturer: Dr Ronen Almog
26/10/2010 Day Course	Validation of Ethylene Oxide (EtO) Sterilisation Lecturer: Ms. Shira Rozenberg
02/11/2010 6 - Day Course	Registration in Israel - Drugs, Biologics, Medical Devices and Cosmetics Professional management: Mgr. Efrat Strugo
02/11/2010 Day Course	בדיקת אנדוטוקסינים בתרופות ואביזרים רפואיים (אמ"ר) המוזרקים / מושתלים בגוף Lecturer: Mr. Eliezer Solomon
10/11/2010 Day Course	Simulation/Mock FDA meeting Preparation Lecturer: Ms. Shoshana Friedman
07/12/2010 Day Course	Good Clinical Practice 2010 - Clinical Trials for Medical Device Lecturer: Dr. Monica Tocchi
14/12/2010 2 - Day Course	Sterilization by Radiation Lecturer: Mr. Martell Winters

Past Activities

2010

TBA 6 - Day Course	Professional Retraining for Engineers: Join the Medical Device Industry Professional management: Ms. Yehudith Wexler
16/06/2010 2 - Day Course	Development of Combination Products - Regulatory & Clinical Considerations Lecturer: Dr. Barbara Fant
TBA Day Course	Endotoxin Testing in Drugs and Medical Devices – the Basics Lecturer: Mr. Eliezer Solomon
TBA Day Course	Clinical Leadership and Governance for Trial Sponsors Lecturer: Dr. Monica Tocchi
11/05/2010 Day Course	Regulatory Strategies for Medical Device Lecturer: Ms. Shoshana Friedman
10/05/2010 Day Course	A Beginners Practical Guide to Medical Device Regulations Lecturer: Dr. Judah Lando
TBA Day Course	Design Control In the Medical device Industry Lecturer: Ms. Veronick Gesner
28/04/2010 Day Course	Phase Appropriate GMP for Investigational Products Lecturer: Ms. Karen Ginsbury
TBA Meeting	WEEE, RoHS and REACH - Important legal issues for producers of Medical Devices Lecturer: Tina Bao, adv
TBA Day Course	Risk Management for Medical Devices Lecturer: Mr. Gadi Shtepel
	Mandatory requirements for Risk Management in the Design, Development and Manufacturing of Medical Devices are defined in ISO 13485:2003 and ISO 14971:2007 standards. The ISO 14971:2007 was also recognized by the FDA as a Consensus Standard for Risk Management.
22/03/2010 2 - Day Course	Medical Device Clinical Studies & Clinical Evaluation for CE Marking in 2010 Lecturer: Dr. Monica Tocchi
	This course is intended for manufacturers who are planning to bring their devices to the European market and need clinical data to support their product claims according with the new EU Directives, which take effect on March 21, 2010. One key change is the requirement of more clinical data for devices placed on the market in any of the 27 EU member nations. For clinical investigations, there will be more scrutiny of clinical dossiers and communication between authorities, for example, refusal from one country will be shared with all other nations. Devicemakers need practical tools for immediate compliance with the new requirements, that this course will provide.
TBA Day Course	Audits of Medical Devices - Implementation of the ISO 13485:2003 Lecturer: Ms. Rita Gabay
TBA Day Course	סדנא ייחודית לשיווק מוצרים Lecturer: Mr Itzik Landau
21/02/2010 Meeting	Medical Device Companies Lecturer: Mr. Clay Anselmo
	This course will give an overview on worldwide regulatory frameworks, discussing how to develop Regulatory and QMS strategies to meet the business needs.

2009

22/12/2009 2 - Day Course	Planning and performing internal audits according to the GMP Lecturer: Dr. Orna Dreazen
	Throughout the course, we shall be discussing the various components of planning an audit based on risk management, performing an audit and drawing conclusions from internal audits. We shall also discuss the evaluation of the effectiveness of the corrective measures implemented by the organization.
15/12/2009 Day Course	The New Euro Directive for Medical Devices Lecturer: Dr. Christian Jarling
	This seminar gives instructions how to assemble a Technical File in compliance with the European Directives on Medical Devices. This file shall not only comply with the regulatory requirements, but also give an understanding, what a reviewer / auditor expects from a Technical File.
25/11/2009 2 - Day Course	Regulatory Affairs of Medical Devices Lecturer: Ms. Shoshana Friedman
TBA Day Course	Listen to the Voice of Process - Control charts for use in establishing manufacturing processes stability Lecturer: Dr. Judah Lando
TBA Day Course	How to Prepare for a CMDCAS Audit Lecturer: Dr. Christian Jarling
	This seminar is dedicated to manufacturers, who already have a quality management system according to ISO 13485, but who want to integrate the additional regulatory aspects required for Canada. Based on practical examples problem areas and possible solutions will be discussed.
TBA Day Course	Documenting Clinical Trials Lecturer: Dr. Monica Tocchi
	Writing for and about clinical research in human subjects demands special attention to rules. Learn how to write clear and complete documentation of clinical trials. Effective clinical dossiers are approved more quickly, facilitate protocol compliance and enhance trial quality. This ultimately leads to optimal product labeling, allowing successful marketing and maximization of advertising claims.
22/06/2009 6 - Day Course	Registration in Israel - Drugs, Biologics, Medical Devices and Cosmetics Professional management: Mgr. Efrat Strugo
TBA 2 - Day Course	Medical Device Clinical Studies & Clinical Evaluation for CE Marking Lecturer: Dr. Monica Tocchi
TBA 6 Meetings	Professional Retraining for Engineers: Join the Medical Device Industry Professional management: Ms. Yehudith Wexler
TBA Day Course	Validation of Ethylene Oxide (EtO) Sterilisation Lecturer: Ms. Shira Rozenberg
TBA Day Course	Post-Marketing Strategies for Medical Devices – how to keep your device on the market Lecturer: Ms. Shoshana Friedman
TBA Day Course	Quality Systems for the Manufacturing of Medical Devices – ISO 13485:2003, and 21 CFR 820 Lecturer: Ms. Shoshana Friedman
TBA Day Course	LAL Process Validation for Endotoxin Testing Lecturer: Mr. Eliezer Solomon
TBA 2 - Day Course	Sterilization by Radiation Lecturer: Mr. Martell Winters, USA
TBA 2 - Day Course	Ethylene Oxide Sterilization Lecturer: Mr. Daniel Floyd, USA
	Join us for this two day workshop offering an opportunity to further your understanding of microbiological basics, sterilization basics, ethylene oxide sterilization methods, and discussions on the appropriate way to develop, validate, and optimize your sterilization cycle.
TBA Day Course	Risk Management for Medical Devices Lecturer: Mr. Gadi Shtepel
	Mandatory requirements for Risk Management in the Design, Development and Manufacturing of Medical Devices are defined in ISO 13485:2003 and ISO 14971:2007 standards. The ISO 14971:2007 was also recognized by the FDA as a Consensus Standard for Risk Management.
11/02/2009 Day Course	Risk Management Strategy Planning Lecturer: Dr. Malcolm Ross, Switzerland
	Although risk management in the industry is not new, recently the Regulatory Authorities are making it a formal requirement through such initiatives as ICH Q9 [Quality Risk Management] and the FDA’s Risk Evaluation and Mitigation Strategy for new drugs.

2008

17/12/2008 Day Course	GMPs in the Manufacture of Clinical Trials Material Lecturer: Ms. Karen Ginsbury
	In July 2008, FDA released a final guidance along with a final rule exempting pharmaceutical manufacturers from the provisions of 21CFR part 211 – GMPs for Finished Pharmaceuticals if manufacturing material for use solely in phase I studies. The EU on the other hand has passed legislation requiring batch release and certification of any investigational medicinal product by a Qualified Person. This course will review the new FDA guidance comparing and contrasting it with the EU GMP requirements in Annex 13.
16/09/2008 2 - Day Course	Planning and performing internal audits according to the GMP Lecturer: Dr. Orna Dreazen
	Throughout the course, we shall be discussing the various components of planning an audit based on risk management, performing an audit and drawing conclusions from internal audits. We shall also discuss the evaluation of the effectiveness of the corrective measures implemented by the organization.
17/06/2008 Day Course	דה-פירוגנציה Lecturer: Mr. Eliezer Solomon
31/03/2008 Day Course	Listen to the Voice of Process - Control charts for use in establishing manufacturing processes stability Lecturer: Dr. Judah Lando
19/02/2008 2 - Day Course	Medical Device Clinical Studies in Europe & Clinical Evaluation for CE Marking Lecturer: Dr. Monica Tocchi, Italy
TBA 2 - Day Course	Regulatory and Clinical Considerations in the Development of Combination Products Lecturer: Dr. Barbara S. Fant, Pharm.D., USA
	Development and FDA approval of a combination product is inherently more complex than individual entity products. This course will provide an overview of the regulatory pathway and the development lifecycle for combination products. Characteristics that are common and those that are unique to medical device, drug, and biologic development will be presented. Considerations in clinical trial design, project management, and clinical monitoring of combination product clinical trials will be presented.

2007

12/07/2007 Day Course	Technical Files Lecturer: Dr. Christian Jarling, Germany
	This seminar provides instructions of how to write and/or assemble a Technical File in compliance with the European Directives on Medical Devices (MDD - 93/42/EEC), as well as understanding the reviewer / auditor point of view; what a reviewer / auditor expects from a Technical File?
11/07/2007 Day Course	Risk Management Lecturer: Dr. Christian Jarling, Germany
	This seminar will demonstrate the procedure of how to analyse, assess and manage risks inherent in a specific medical device and will discuss means of properly documenting the outcome. In addition, upcoming changes in the risk management standard will be included in the seminar.
10/07/2007 Day Course	Sterilization of Medical Devices: Validation & Documentation Lecturer: Dr. Christian Jarling, Germany
	The seminar will present the requirements of the revised sterilization standards for medical devices. Specific aspects of steam, ethylene oxide, gamma and beta irradiation, and plasma sterilization will be addressed.
09/07/2007 Day Course	The New Euro Directive for Medical Device Lecturer: Dr. Christian Jarling, Germany
08/05/2007 Day Course	Sterilization by Radiation Lecturer: Mr. Martell Winters, USA