Validation

Upcoming

2010

26/10/2010 Day Course	Validation of Ethylene Oxide (EtO) Sterilisation Lecturer: Ms. Shira Rozenberg
02/11/2010 Day Course	בדיקת אנדוטוקסינים בתרופות ואביזרים רפואיים (אמ"ר) המוזרקים / מושתלים בגוף Lecturer: Mr. Eliezer Solomon
03/11/2010 Day Course	Product Quality Review as a Tool for Continued Process Verification Lecturer: Ms. Karen Ginsbury
09/11/2010 3 - Day Course	Process Validation Lecturer: Dr. Eli Schmell
30/11/2010 Day Course	Cleaning Validation Lecturer: Ms. Karen Ginsbury
14/12/2010 2 - Day Course	Development and Validation of Bioassays Lecturer: Dr. Ana Menendez, USA
	The lecture portion of this course will outline sensible approaches to develop reproducible bioassays using live systems and/or biologically derived reagents. These approaches will be supplemented by guidelines to meet regulatory requirements according to their application. In addition, a workshop on writing validation protocols will provide hands-on experience to cover this pivotal document. During the course students will also hear caser studies that will add relevance to the lecture materials and provide a launch point for class discussion.

Past Activities

2010

01/06/2010 2 - Day Course	Stability-Indicating Methods: Development of validatable stability-indicating methods and Validation in compliance with FDA/ICH guides Lecturer: Dr. Raphy Bar
26/05/2010 Day Course	System & Equipment Qualification & Validation Lecturer: Ms. Karen Ginsbury
	Every regulatory inspection and customer audit reviews validation qualification files. Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) as well as validation protocols and reports are all essential elements of a modern pharmaceutical quality system. This one day course will review the GMP requirements relating to validation, guidelines and regulatory expectations as well as inspectional approaches to this critical topic.
03/05/2010 2 - Day Course	Validation of Analytical Methods Lecturer: Dr. Hagit Yariv
29/04/2010 Day Course	Technology Transfer of Analytical Methods Lecturer: Dr. Raphy Bar
	Analytical methods once validated, are often transferred and implemented in other laboratories. Thus, methods can be transferred from an R&D lab to a QC lab in the same or different site, or to an external CRO lab.
08/03/2010 2 - Day Course	Validation of analytical methods in compliance with FDA/ICH/USP guidance - ADVANCED-LEVEL COURSE Lecturer: Dr. Raphy Bar
	This advanced course is aimed at teaching the various performance characteristics of analytical methods while providing the participant with a deeper insight and understanding of the design and implementation of these validation parameters.

2009

15/07/2009 Day Course	How Current Are You? Review of New Industry and Regulatory Expectations For Biopharmaceutical Products Lecturer: Dr. Ana Menendez, USA
	2008 was a banner year for generating important industry white papers and regulatory guidelines for biopharmaceutical products. This meeting specifically addresses updates that should be implemented in post-2009 development and validation programs both in the GMP and the GLP arena.
TBA 2 - Day Course	Validation of Analytical Methods Lecturer: Dr. Hagit Yariv
13/07/2009 2 - Day Course	Development and Validation of Bioassays Lecturer: Dr. Ana Menendez, USA
	The lecture portion of this course will outline sensible approaches to develop reproducible bioassays using live systems and/or biologically derived reagents. These approaches will be supplemented by guidelines to meet regulatory requirements according to their application. In addition, a workshop on writing validation protocols will provide hands-on experience to cover this pivotal document. During the course students will also hear caser studies that will add relevance to the lecture materials and provide a launch point for class discussion.
07/07/2009 2 - Day Course	Software Validation - Practical Aspects Lecturer: Mr. Mike Zeevi
06/07/2009 Day Course	Validation of USP / EP Sterility Test Lecturer: Mr. Alexander Gulkarov
TBA Day Course	Validation of Ethylene Oxide (EtO) Sterilisation Lecturer: Ms. Shira Rozenberg
TBA Day Course	LAL Process Validation for Endotoxin Testing Lecturer: Mr. Eliezer Solomon
05/02/2009 Day Course	Analytical Methods - Technology Transfer & Verification Lecturer: Dr. Raphy Bar
	Analytical methods once validated, are often transferred and implemented in other laboratories. Thus, methods can be transferred from an R&D lab to a QC lab in the same or different site, or to an external CRO lab.

2008

01/12/2008 2 - Day Course	Pharmaceutical Microbiology Lecturer: Ms. Karen Ginsbury
TBA Day Course	Validation of analytical methods in compliance with FDA/ICH/USP guidance - ADVANCED-LEVEL COURSE Lecturer: Dr. Raphy Bar
	This advanced course is aimed at teaching the various performance characteristics of analytical methods while providing the participant with a deeper insight and understanding of the design and implementation of these validation parameters.
11/06/2008 Day Course	Validation of Analytical Methods Lecturer: Dr. Hagit Yariv
28/01/2008 Day Course	Qualification and Validation of Pharmaceutical Equipment Lecturer: Ms. Karen Ginsbury
	The course will be delivered in Hebrew

2007

29/10/2007 2 - Day Course	Development and Validation of Bioassays Lecturer: Dr. Ana Menendez, USA
	The lecture portion of this course will outline sensible approaches to develop reproducible bioassays using live systems and/or biologically derived reagents. These approaches will be supplemented by guidelines to meet regulatory requirements according to their application. In addition, a workshop on writing validation protocols will provide hands-on experience to cover this pivotal document. During the course students will also hear caser studies that will add relevance to the lecture materials and provide a launch point for class discussion.
19/09/2007 Day Course	Validation of analytical methods in compliance with FDA/ICH/USP guidance - ADVANCED-LEVEL COURSE Lecturer: Dr. Raphy Bar
07/05/2007 Day Course	Packaging Validation Lecturer: Mr. Martell Winters, USA
19/02/2007 Day Course	Validation of Analytical Methods Lecturer: Dr. Hagit Yariv

2006

13/11/2006 Day Course	Equipment Validation Lecturer: Ms. Karen Ginsbury
16/05/2006 2 - Day Course	Process Validation Lecturer: Dr. Eli Schmell
21/03/2006 Day Course	Validation of Ethylene Oxide (EtO) Sterilisation Lecturer: Shira Rozenberg