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מנוי

Medical Devices

Home :: All Courses Number of Courses: 70

Upcoming

2018

17/10/2018
1 - Day Course
GAMP5 - יישום גישת ניהול סיכונים במערכות ממוחשבות
Lecturers: Ms. Daphna Spector-Grossbard
 
24/10/2018
2 - Day Course
Regulatory Affairs of Medical Devices
Lecturer: Ms. Shoshana Friedman
 
31/10/2018
1 - Day Course
Risk Management Workshop
Lecturer: Ms. Bosmat Friedman, Ms. Shoshana Friedman
 
04/11/2018
2 - Day Course
מבדקי אמ"ר
Lecturer: Ms. Iris Leinwand
 
28/11/2018
1 - Day Course
Control of Suppliers and Sub Contractors
Lecturer: Mr. Gadi Shtepel
 
27/12/2018
1 - Day Course
אמ"ר משולב ענן IoMT
Lecturer: Mr. Guy Vinograd
 

TBA

TBA
1 - Day Course
שחרור תרופות מתוך מערכות מושתלות
Lecturer: Dr. Adel Penhasi
 
TBA
2 - Day Course
Pre-Clinical Drug Safety Evaluation in Drug and Biologic Development
Lecturer: Dr. Shayne Gad
 
TBA
3 - Day Course
Safety Assessment for Medical Devices and Combination Products
Lecturer: Dr. Shayne Gad
 
TBA
1 - Day Course
Internal Audits and Management Review
Lecturer: Mr. Gadi Shtepel
 
TBA
1 - Day Course
Test Methods & Measurement Systems Validation for Medical Device
Lecturer: Mr. Gadi Shtepel
 
TBA
1 - Day Course
Medical Devices Regulation in Canada
Principles and Recent Updates

Lecturers: Dr. Valentin Fulga, Ms. Netta Fulga
 
TBA
2 - Day Course
Regulation of Combination Products
Lecturer: Dr. Hagit Marchaim, Dr. Sara Horn
 

Past Activities

2018

14/06/2018
2 - Day Course
Planning and performing internal auditsaccording to the GMP
Lecturer: Dr. Orna Dreazen
 
10/06/2018
1 - Day Course
Design Control
Lecturer: Ms. Veronick Gesner
 
04/06/2018
1 - Day Course
Preparing a 510(k)
Hands-on Workshop

Lecturer: Ms. Shoshana (Shosh) Friedman, RAC, FRAPS
 
29/05/2018
2 - Day Course
From MDD to EU MDR
Lecturers: Mr. Robert Van Boxtel
 
15/03/2018
1 - Day Course
The Pre-Submission Program
and Meetings with FDA Staff

Lecturer: Ms. Shoshana (Shosh) Friedman, RAC, FRAPS
 
14/03/2018
1 - Day Course
Clinical Trials with Medical Device
From Design to Final Report

Lecturer: Ms. Shoshana (Shosh) Friedman, RAC, FRAPS
 
06/02/2018
1 - Day Course
Documentation Control, Change Control & Configuration Management
Lecturer: Mr. Gadi Shtepel
 
02/01/2018
1 - Day Course
Steam Sterilization
Quality Assurance in Routine Monitoring

Lecturer: Mr Shlomi Bitterman
 

2017

27/12/2017
1 - Day Course
EtO – sterilization of Medical device
Lecturers: Mr. Harry Leinwand
 
06/12/2017
1 - Day Course
Sampling Plans for V&V, Incoming Inspection and Release
Lecturer: Mr. Gadi Shtepel
 
20/11/2017
2 - Day Course
Regulatory Affairs of Medical Devices
Lecturer: Ms. Shoshana Friedman
 
18/09/2017
1 - Day Course
Customer Complaints, Vigilance Reporting and Post Market Surveillance
Lecturer: Mr. Gadi Shtepel
 
17/05/2017
1 - Day Course
ProMedoss Event 2017
:
 
15/03/2017
1 - Day Course
FDA Update: New Requirements, Trends and Guides
Lecturer: Ms. Shoshana Friedman
 
06/03/2017
1 - Day Course
Getting FDA Clearance/Approval for Medical Devices
What, When and How?

Lecturer: Ms. Shoshana Friedman
 
21/02/2017
1 - Day Course
Design Control
Lecturer: Ms. Veronick Gesner
 
01/02/2017
1 - Day Course
Metals and Alloys for the Medical Device Industry
Lecturer: Mr Idan Tobis
 

2016

13/12/2016
2 - Day Course
ISO 13485:2016 and EU MDR
Lecturers: Mr. Robert van Boxtel, Ms. Veronick Jasner
 
20/09/2016
2 - Day Course
Software Validation - Practical Aspects
Lecturer: Mr. Mike Zeevi
 
14/09/2016
1 - Day Course
Process Validation for Medical Devices
Lecturer: Mr. Gadi Shtepel
 
13/09/2016
2 - Day Course
Planning and performing internal audits
according to the GMP

Lecturer: Dr. Orna Dreazen
 
06/06/2016
1 - Day Course
Non Conforming Product and CAPA systems
Lecturer: Mr. Gadi Shtepel
 
03/05/2016
1 - Day Course
EU Technical File
How to Prepare and Submit

Lecturer: Dr. Raanan Aloni
 
01/05/2016
1 - Day Course
Risk Management for Medical Devices

Lecturer: Mr. Gadi Shtepel
 
03/02/2016
1 - Day Course
GAMP5 - יישום גישת ניהול סיכונים במערכות ממוחשבות
Lecturers: Ms. Daphna Spector-Grossbard
 
01/02/2016
1 - Day Course
FDA Regulatory Updates in Medical Device
Lecturer: Ms. Sarit Gelbert
 

2015

07/06/2015
3 - Day Course
GMP בחדרים נקיים וסביבת עבודה מבוקרת – קורס מעשי
Lecturers: Dr. Moti Yizhar
 
23/03/2015
1 - Day Course
Compliance with Medical Device Standards and Regulations
Lecturer: Dr. Judah Lando
 

2014

12/11/2014
3 - Day Course
Develop Your Skills as an Effective Auditor for the Medical Device Industry
Lecturer: Mrs. Yana Prus-Galynsky
 
30/06/2014
1 - Day Course
US FDA Quality System Requirements (21 CFR Part 820)
Lecturer: Dr. Judah Lando
 

2013

08/10/2013
1 - Day Course
MDDMI Conference
Professional management: Ms. Yehudith Wexler
 
28/05/2013
1 - Day Course
Preparing For and Passing an FDA Inspection
Lecturer: Mr. Michael Anisfeld, USA
 

2012

06/08/2012
1 - Day Course
Usability Engineering
Lecturer: Mr. Nissim Oz
 
17/05/2012
1 - Day Course
Phase Appropriate GMP for Investigational Products
Lecturer: Ms. Karen Ginsbury
 
17/01/2012
1 - Day Course
A Beginners Practical Guide to Medical Device Regulations
Lecturer: Dr. Judah Lando
 

2011

12/09/2011
1 - Day Course
CRF Design Workshop
Lecturer: Ms. Tali Azulay
 
27/07/2011
1 - Day Course
Regulatory Intelligence (RI)
Lecturer: Mr. Daniel Albahari
 
04/04/2011
2 - Day Course
Sterilization by Radiation
Lecturer: Mr. Martell Winters
 

2010

28/12/2010
1 - Day Course
Validation of Ethylene Oxide (ETO) Sterilisation
Lecturer: Ms. Shira Rozenberg
 
16/06/2010
2 - Day Course
Development of Combination Products - Regulatory & Clinical Considerations
Lecturer: Dr. Barbara Fant
 
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

15/12/2009
1 - 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.
22/06/2009
6 - Day Course
Registration in Israel - Drugs, Biologics, Medical Devices and Cosmetics
Professional management: Mgr. Efrat Strugo
 
11/02/2009
1 - 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

17/06/2008
1 - Day Course
דה-פירוגנציה
Lecturer:
 
31/01/2008
1 - Day Course
Cell Analysis - Clinical Applications
Lecturer:
 

2007

18/12/2007
1 - Day Course
Post-Marketing Strategies for Medical Devices – how to keep your device on the market
Lecturer: Ms. Shoshana Friedman
  The course provides an overview of the post-marketing regulation of medical devices in the US and focuses on developing post-marketing strategies to ensure regulatory compliance and maintain marketing authorizations.
12/07/2007
1 - 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
1 - 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.

2006

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