Management Strategies

Upcoming

2011

TBA Day Course	Risk Management & Regulations - The Risk Based Approach Lecturer: Mr. Nissim Oz
	This course aims to prepare participants for proper risk management discipline.
TBA Day Course	Efficient Management in Quality Operation Lecturer: Mr. Rafi Maslaton
TBA 2 - Day Course	Creating and Managing an Intranet Portal as a Knowledge Mangement Tool Lecturer: Dr. Nava Rotem
TBA Day Course	Sample Size Calculation Lecturer: Mr Gil Harari
22/05/2011 3 - Day Course	Role, Responsibilities and Activities of the Qualified Person in the European Union Lecturers: Dr. Christopher Burgess, Mr. Richard Bonner
25/05/2011 Day Course	The Role of the Qualified Person (QP) of Pharmaceutical and Veterinary Manufacturers and Importers in Israel Lecturers: Dr. Christopher Burgess, Mr. Richard Bonner

2010

07/11/2010 2 Meetings	Regulatory Affairs and Quality for Managers Lecturer: Rivka Zaibel
TBA 2 - Day Course	Risk Management Throughout a Drug Lifecycle Lecturer: Dr Stanley Garbus
	The course is based on the risk (risk/benefit assessment) for prescription drug products but the concept of Risk Management and Mitigation is universal and being recognized by regulatory authorities as necessary for devices and biotech products as well.
08/12/2010 2 - Day Course	Clinical Project Management Lecturer: Dr Stanley Garbus
	The course begins by describing the basic fundamentals and pharmaceutical industry standards of project management techniques. Details are presented for understanding clinical trial costs and developing timely budgets to create successful study completion on budget. Participants learn skills of leadership, negotiation and communication that will positively impact the success of clinical projects.

Past Activities

2010

08/06/2010 Day Course	Managing Calibration Systems as Part of the QA System Lecturers: Dr. Orna Dreazen, Mr. Teddy Hoffman
11/05/2010 Day Course	Regulatory Strategies for Medical Device Lecturer: Ms. Shoshana Friedman
24/03/2010 2 - Day Course	RCA - Root Cause Analysis Lecturer: Dr Malcolm Ross
TBA 2 - Day Course	Strategic and Risk Management in a Drug Development Lecturer: Dr. Yitzchak Angel
TBA Day Course	Strategies and Resources for Effective GMP Training Lecturer: Ms. Karen Ginsbury
	This one day seminar will provide a novel approach to training strategies moving away from the classic “read and understand” and frontal approaches. Tools will be presented for risk communication and to engage personnel at all levels of the company in understanding why they have to do what they have to do.

2009

TBA Day Course	QC Managers Forum : Dr. Orna Dreazen
TBA Day Course	Advanced Methods for Promoting Industry Excellence Lecturer: Dr. Sigalit Arieli-Portnoy
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.
TBA 6 - Day Course	Drug development - strategy and principles Lecturer: Dr. Yitzchak Angel

2008

26/11/2008 Day Course	Managing Calibration Systems as Part of the QA System Lecturers: Dr. Orna Dreazen, Mr. Teddy Hoffman
07/09/2008 2 - Day Course	Pharmaceutical Product Risk Lecturer: Dr Stanley Garbus (USA)
	The course is based on the risk (risk/benefit assessment) for prescription drug products but the concept of Risk Management and Mitigation is universal and being recognized by regulatory authorities as necessary for devices and biotech products as well.
03/09/2008 2 - Day Course	Clinical Project Management Lecturer: Dr Stanley Garbus - USA
	The course begins by describing the basic fundamentals and pharmaceutical industry standards of project management techniques. Details are presented for understanding clinical trial costs and developing timely budgets to create successful study completion on budget. Participants learn skills of leadership, negotiation and communication that will positively impact the success of clinical projects.
TBA Day Course	Efficiency in Quality Operation & Managing Batch Records Lecturer: Mr. Rafi Maslaton - USA
	In today's business environment, a quality organization that focuses strictly on compliance while ignoring inefficiency will not succeed. This course discusses efficiency management throughout the quality operations with the main focus on batch record release. While for many years QA was predominantly a compliance organization, and it existence was associated with the cost of doing business, this course will outline how we can manage both compliance and efficiency.
TBA 2 - Day Course	Operation Excellence in the Pharmaceutical Industry Lecturer: Mr. Rafi Maslaton, USA
	Streamlining your entire supply chain – shorter release time, better quality, higher productivity, lower cost, and improved customer satisfaction – are the goals of any company. This two-day workshop on excellence in operations will focus on achieving these goals while dealing with demanding compliance requirements, increased competition and higher costs.
TBA 6 Meetings	Accelerated Drug Development - Risk Management Strategies Lecturer: Dr. Yitzchak Angel

2007

21/11/2007 Day Course	QC Lab Management Lecturers: Amit Lahav, Larisa Amir, Dr. Orna Dreazen, Ruth Huberman, Mr. Teddy Hoffman
10/09/2007 Day Course	Supply Chain Risk Management in the pharmaceutical and healthcare industries Lecturer: Mr. David Inbar

2006