Quality

Upcoming

2011

TBA Day Course	Efficient Management in Quality Operation Lecturer: Mr. Rafi Maslaton
TBA Day Course	Israeli Legislation on the Quality of Drugs and Biologics Lecturers: Dr. Rachel Karpel, Adv. Yoel Lifshitz
TBA 2 - Day Course	Sterilization by Ethylene Oxide Lecturer: Mr. Daniel Floyd
TBA 3 - Day Course	Statistical Analysis of the Composition and Homogeneity of Mixtures Lecturer: Dr. Evgeny Tartakovsky
TBA Day Course	Troubleshooting in Sterilization & Microbiological Testing of MD Lecturers: Mr. Daniel Floyd, Mr. Martell Winters
TBA 2 - Day Course	Creating and Managing an Intranet Portal as a Knowledge Mangement Tool Lecturer: Dr. Nava Rotem
TBA Day Course	Calibration and measurements – a full day course including also the new requirements according to the ISO/IEC/EN17025 standard Lecturer: Mr. Teddy Hoffman
	Apart from other aspects of measurements and calibration this course will analyze the new edition (2005) of standard ISO/IEC/EN 17025, including practical implementation of the requirements in the daily work routine.
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
26/05/2011 Day Course	Writing and Understanding Technical Agreements Lecturers: Dr Christopher Burgess, Mr. Richard Bonner

2010

20/09/2010 Day Course	CRF design workshop Lecturer: Ms. Tali Azulay
06/10/2010 Day Course	Product Lifecycle and Product Control Strategy - ICH Q8, Q9, Q10 Lecturer: Ms. Karen Ginsbury
	This one day seminar will take a novel look at product and process development through marketing in the light of the newest ICH guidances. A product control strategy and a lifecycle approach to product and process management are regulatory requirements – the EU is in the process of updating Chapter 1 of the EU GMPs to incorporateICH Q10 Pharmaceutical Quality System. ICH Q9 and the principles of Risk Management are already incorporated.
13/10/2010 2 - Day Course	Uncertainty in calibration and measurements Lecturer: Mr. Teddy Hoffman
	This course will clarify parameters in calibration and measurements. Participants will receive the tools necessary to evaluate the uncertainty and to start to calculate it.
20/10/2010 Day Course	GMPs for Printed Packaging Materials Lecturer: Ms. Karen Ginsbury
	The goal of the course is to provide participants with an understanding of the inherent dangers and complexity of handling, managing and controlling printed packaging materials so as to minimize the likelihood of inaccuracies in text, of mix-up of versions and / or of product recall because of packaging or labeling mix-ups.
20/10/2010 3 - Day Course	CIP Technology Lecturer: Mr. Moshe Landsberg
25/10/2010 3 - Day Course	GDP - תנאי הפצה נאותים Professional management: Mgr. Efrat Strugo
26/10/2010 Day Course	Validation of Ethylene Oxide (EtO) Sterilisation Lecturer: Ms. Shira Rozenberg
26/10/2010 Day Course	Quality assurance on calibration and measurements including the updated requirements according to the new edition of the ISO/IEC/EN17025 standard Lecturer: Mr. Teddy Hoffman
	This course is intended for all the people working in measurements and calibration, including quality managers knowing the basic rules on this domain and desiring to go deeply and to enrich their knowledge on metrology and on the new standards and requirements.
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
07/11/2010 2 Meetings	Regulatory Affairs and Quality for Managers Lecturer: Rivka Zaibel
08/11/2010 2 - Day Course	Project Management and Change Control Lecturer: Ms. Karen Ginsbury
08/11/2010 Day Course	A GMP Inspector’s Perspective on Compliance Lecturer: Mr. Michael Anisfeld, USA
	Effective Quality Risk Management and Corrective + Preventive Action (CAPA) Systems. Minimize Failure, Maximize Profits and Effectively Meet the Latest GMP Compliance Requirements from Inspection Agencies World-wide. Total Compliance to EU GMPs Annex 20 – “Quality Risk Management”
09/11/2010 3 - Day Course	Process Validation Lecturer: Dr. Eli Schmell
10/11/2010 Day Course	Extractables and Leachables from containers/closures of drugs and from devices Lecturer: Dr. Raphy Bar
	This course will give participants an understanding of how chemicals leached from containers and closures of pharmaceutical and biopharmaceutical drugs as well as from medical devices, are detected and quantified in the framework of a properly designed Extractables/Leachables (E&L) study. Examples of E&L will be presented.
15/11/2010 Day Course	Steam Sterilization – Quality Assurance in Routine Monitoring Lecturer: Mr Shlomi Bitterman
24/11/2010 Day Course	Analytical Standards in Pharmaceutical & Bio-pharmaceutical Laboratories: Qualification of Primary & Secondary Standard Lecturer: Dr. Raphy Bar
24/11/2010 Day Course	Tablet Pro Lecturer: Mr. Michael Tousey, USA
	Tablet Pro (Professional) is a one day comprehensive course covering tablet press operations. The participant will gain a complete understanding of the importance of tablet press set-up, machine function, operation, and cleaning.
30/11/2010 Day Course	Cleaning Validation Lecturer: Ms. Karen Ginsbury
30/11/2010 2 - Day Course	Rapid Microbiological Methods - RMM Lecturer: Dr. Michael Miller
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.
13/12/2010 2 - Day Course	Supplier Approval – Managing Risk in Your Supply Chain Lecturer: Ms. Karen Ginsbury
22/12/2010 2 - Day Course	Analytical Data Serving the QA, Regulatory & Formulation Staff Lecturer: Dr Malcolm Ross
	Analytical chemistry is of major significance in all aspects of the pharmaceutical industry. As staff has become more specialist it is important that people without detailed experience in analytical chemistry understand the fundamental principles involved in order to evaluate the data presented to them. This course is intended to provide a firm basis to enable non-analytical chemists to understand and to evaluate the significance of the data generated in the analytical laboratory.

Past Activities

2010

TBA Day Course	Preventing and Coping with Problems in a Multi-Disciplinary Work Environment Lecturer: Mr. Yoav Gavrieli
TBA Day Course	Pharmaceutical Micro-organisms: Sources, Control Strategies, Isolation, Identification, Challenging, Storage and Handling Lecturer: Ms. Karen Ginsbury
TBA Day Course	Environmental Monitoring Lecturer: Ms. Karen Ginsbury
TBA 2 - Day Course	Microbiological Best Laboratory Practices Lecturer: Ms. Karen Ginsbury
TBA Day Course	CAPA & Q10 Lecturer: Ms. Karen Ginsbury
	This course will look at what CAPA really is, how information is gathered and fed into the system and how issues are investigated to address root cause and resolve the issue, to prevent recurrence.
27/07/2010 Day Course	Impurities in Active Pharmaceutical Ingredients (APIs) and in Pharmaceutical Products Lecturer: Dr. Rachel Karpel
	Impurities in Active Pharmaceutical Ingredients (APIs) and in Pharmaceutical Products
18/07/2010 2 - Day Course	How to Build and Validate Excel Spreadsheets Lecturers: Mr. David Nettleton, Dr. Raphy Bar
TBA Day Course	Writing SOPs - Workshop Lecturer: Ms. Karen Ginsbury
	To review the purpose of SOPs and to provide participants with tools to write their own SOPs that are clear, concise and not open to interpretation. The course will include group exercises and participants will take home an SOP that they have prepared
08/07/2010 Day Course	Data Management & Statistical Methods in Clinical Trials Lecturer: Ms. Tali Azulay, Mr Gil Harari
	The presentation and interpretation of clinical efficacy and safety results from clinical trials is a core component of regulatory submissions for the approval of medical products and devices. These results, in turn, derive from clinic data which is collected through a regulated process involving clinical trial Sponsors, investigative sites, and contract research organizations.
07/07/2010 Day Course	Quality Assurance in the QC Laboratory Lecturer: Ms. Karen Ginsbury
TBA 3 - Day Course	Introduction to GMP and Quality Assurance for Manufacture and Control of Finished Pharmaceuticals Lecturer: Ms. Karen Ginsbury
	Participants will graduate this course with an understanding of the GMP regulations and an idea of how and why they need to be implemented
23/06/2010 3 - Day Course	Regulatory and Quality requirements for the registration of Biologics/Biotechnology Products Lecturer: Rivka Zaibel
TBA 3 - Day Course	Workshop - GMP in a Clean Room Facility Lecturers: Dr. Moti Yizhar, Dr. Rasooly
08/06/2010 Day Course	Managing Calibration Systems as Part of the QA System Lecturers: Dr. Orna Dreazen, Mr. Teddy Hoffman
02/06/2010 3 - Day Course	Troubleshooting and Solving Problems in HPLC - Advanced Lecturer: Dr. Shulamit Levin
	Especially the experienced chemists might find be surprised
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.
13/05/2010 Day Course	ICH, EMEA and FDA Guidelines for Drug and Drug-Substances Stability Lecturer: Dr. Rachel Karpel
TBA Day Course	Quality Aspects in Management of Contract Manufacturers Lecturer: Ms. Karen Ginsbury
TBA Day Course	Design Control In the Medical device Industry Lecturer: Ms. Veronick Gesner
04/05/2010 Day Course	Pharmacopoeias and Compendial Testing of Pharmaceuticals Lecturer: Dr. Raphy Bar
	US and European pharmacopoeias are independent organizations that set the standards for determining the quality of pharmaceutical products marketed in the US or Europe. These standards govern the quality, strength, purity and potency of active pharmaceutical ingredients, dosage forms and excipients as well as many reagents and solutions used to test these materials. USP and Ph.Eur. are legally recognized compendia for regulatory agencies and they are widely used by the pharmaceutical industry. Any pharmaceutical testing laboratory must be capable of applying the tests described in the compendial monographs.
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.
28/04/2010 Day Course	Phase Appropriate GMP for Investigational Products Lecturer: Ms. Karen Ginsbury
26/04/2010 Day Course	Atomic Absorption – AA Lecturer: Dr. Yaakov Tabak
TBA Day Course	Analytical Instrument Qualification Lecturer: Ms. Karen Ginsbury
	This one day seminar will review the USP Chapter on Analytical Instrument Qualification (AIQ) in the perspective of regulatory requirements (EU and FDA), guidance and expectations.
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.
TBA 4 - Day Course	Quality in Registration Files Lecturer: Dr. Rachel Karpel
12/04/2010 2 - Day Course	HVAC Systems Lecturers: Ms. Karen Ginsbury , Uri Harel
	There is no pharmaceutical facility that is not equipped with a controlled HVAC system. Pharmaceutical facilities are provided with filtered air to ensure an environment that is controlled with respect to particle contamination: both viable and non-viable. This course will provide participants with an understanding of the design of such systems, GMP requirements behind the design, qualification and ongoing operation, maintenance and monitoring.
24/03/2010 2 - Day Course	RCA - Root Cause Analysis Lecturer: Dr Malcolm Ross
22/03/2010 Day Course	Conducting, Documenting and Ensuring Effective Investigations Lecturers: Ms. Karen Ginsbury, Dr. Rachel Karpel
	At the end of this course participants will understand how to effectively investigate deviations and untoward events.
TBA Day Course	Audits of Medical Devices - Implementation of the ISO 13485:2003 Lecturer: Ms. Rita Gabay
04/03/2010 4 - Day Course	Advanced HPLC Lecturer: Mr. Igal Gozlan
TBA 2 - Day Course	Drug Safety Lecturer: Ms. Orit Neudorfer
	This course will review the history of drug safety until present days, and describe how safety management has changed its scope to achieve its new challenges. Development of safety strategy, from early development, throughout clinical phases until post-marketing, will be studied, including the establishment of an effective risk management plan.
24/02/2010 Day Course	Enhancing Laboratory Efficiency , a Course for Managers Lecturer: Dr. Sigalit Arieli-Portnoy
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.
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.
16/02/2010 2 - Day Course	Water Systems in the Pharmaceutical & Biotechnological Industries Lecturer:
08/02/2010 Day Course	Change Management According to the Q10 Guidelines Lecturer: Ms. Karen Ginsbury
	This one day, intensive course will address management of change in an industry that has been traditionally skeptical of the need or desire to improve systems that aren’t actually broken.
TBA Day Course	How to disable your next regulatory clinical site inspection Lecturer: Mr. Steve Schwartz
	This course will benefit the investigators and site staff who will be inspected, the sponsor CRA, and institution quality staff and clinical administrators.
02/02/2010 3 - Day Course	Developing Clinical Quality Assurance Audit Skills and Procedures (CQA) Lecturer: Mr. Steve Schwartz, USA
21/01/2010 Day Course	CITAC Workshop Lecturers: Dr.I.Kuselman, Dr. W.Koch, Prof.H.Emons, Prof.I.Leito, Prof. P.De Bievre, Dr. J.Messman
	The course will cover metrological principles and practice in analytical laboratories important for quality assurance of analytical results, required by GLP & GMP standards, ISO/IEC 17025 standard, spread for competence of testing laboratories, other international documents and regulations. Use of reference materials as measurement standards, calculation of measurement uncertainty of analytical results, traceability of a routine result to national and international measurement standards and System International of Units (SI), interlaboratory comparisons and proficiency testing are the topics of the course.
19/01/2010 Day Course	GMP עיקור בסביבת Professional management: Ms. Yehudith Wexler
	Isranalytica 2010 – Related Events
TBA Day Course	Auditing Manufacturers of Starting Materials Lecturer: Ms. Karen Ginsbury
	At the end of this course participants will understand how to pre-audit, how to schedule and conduct effective audits in limited timeframes and how to follow up on implementation of effective corrective and preventive actions to your audit findings.

2009

TBA Day Course	Risk Management of APIs Manufacture Lecturer: Ms. Karen Ginsbury
TBA Day Course	Audits of APIs Manufacturers Lecturer: Ms. Karen Ginsbury
TBA Day Course	Multiproduct or Dedicated Facilities Lecturers: Ms. Karen Ginsbury
	European regulators and US FDA are currently co-operating in developing an approach to the handling of potent compounds and the use of multi-product as opposed to dedicated facilities. Companies, wanting to be as cost effective as possible, while still ensuring patient (and operator) safety, are often interested in performing campaign work for small volume, but potent products. Both industry and regulators alike, are deliberating as to where the red lines are drawn: which compounds or product categories constitute “too high a risk” and must be manufactured in a dedicated facility. The only category which currently carries a consensus is that of Beta Lactam antibiotics, especially penicillin. What about steroids, products derived from mammalian or animal cells, bacterially derived products especially if using spore-forming organisms. What about pre and post viral inactivation activities. The list is long and complex. This one day course, will enable participants to organize their thoughts, understand current regulations as well as those in the making and will teach you how to perform a rugged risk assessment that is likely to pass close regulatory scrutiny. The course will address risk elements associated with API manufacture as well as finished product.
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.
09/12/2009 2 - Day Course	Technology Transfer Lecturer: Dr Malcolm Ross, Switzerland
15/11/2009 3 - Day Course	GMP in a Clean Room Facility Lecturers: Dr. Moti Yizhar, Dr. Rasooly
04/11/2009 2 - Day Course	Quality Assurance of Computerized Systems- A Comprehensive Perception Lecturer: Ms. Daphna Spector-Grossbard
	Quality Assurance of computerized systems in a regulated environment includes a definition of policy and work procedures, implementation of processes based on software development life-cycle, change control and a constructed validation process which are a direct result of a risk assessment procedure.
21/10/2009 Day Course	ICH Quality Guidelines - Q1 through Q10 Lecturer: Ms. Karen Ginsbury
	The 9 finalized Q" guidlines and the Q10, almost final "Q" guidline – what are they about?
TBA Day Course	Listen to the Voice of Process - Control charts for use in establishing manufacturing processes stability Lecturer: Dr. Judah Lando
10/09/2009 Day Course	GMP Aspects of Analytical Quality Control including OOS results Lecturer: Ms. Karen Ginsbury
	The Quality Control Laboratory is consistently featuring at the top of the deficiency lists in regulatory inspections. This is a chance to be up-dated and to minimize the chance of adverse inspectional outcome in your laboratory.
12/08/2009 Day Course	Writing Standard Operating Procedures (SOPs) Workshop Lecturer: Ms. Karen Ginsbury
	To review the purpose of SOPs and to provide participants with tools to write their own SOPs that are clear, concise and not open to interpretation. The course will include group exercises and participants will take home an SOP that they have prepared
10/08/2009 3 - Day Course	Introduction to GMP and Quality Assurance for manufacture and control of Finished Pharmaceuticals Lecturer: Ms. Karen Ginsbury
	Participants will graduate this course with an understanding of the GMP regulations and an idea of how and why they need to be implemented
TBA Day Course	Product Control Strategy – Integrating Risk Management into Product Development Lecturer: Ms. Karen Ginsbury
TBA Day Course	QC Managers Forum : Dr. Orna Dreazen
TBA 2 - Day Course	Uncertainty in calibration and measurements – a two days course / workshop Lecturer: Mr. Teddy Hoffman
	This course will clarify parameters in calibration and measurements. Participants will receive the tools necessary to evaluate the uncertainty and to start to calculate it.
07/07/2009 Day Course	Academic and Industrial Views on the Development of Lipid Based Drug Delivery Systems to Address Oral Bioavailability Challenges Lecturers: Eduardo Jule, Dr. David Edwards, Prof. Meir Shinitzky , Prof. Shimon Benita
01/07/2009 Day Course	Analytical Standards in Pharmaceutical & Bio-pharmaceutical Laboratories: Qualification of Primary & Secondary Standard Lecturer: Dr. Raphy Bar
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.
TBA Day Course	Contamination in Drugs and Drug Substances – Updated Regulatory Requirements Lecturer: Dr. Rachel Karpel
08/06/2009 Day Course	Statistical Criteria for Validation of Analytical Methods Lecturer: Dr. Raphy Bar
	Validation of analytical methods is a common regulatory requirement. Yet, it is a process that is carried out at various levels at different laboratories. However, there is no doubt that a statistical treatment of the validation data brings scientific rigorousness to the experiments and renders the validation report more reliable and more easily acceptable to regulatory agencies. This advanced course concentrates directly on the acceptance criteria of the various performance characteristics of analytical methods and on the statistical tests that answer these criteria.
03/06/2009 2 - Day Course	Analytical Chemistry for non-analytical chemists Lecturer: Dr Malcolm Ross, Switzerland
	Analytical chemistry is of major significance in all aspects of the pharmaceutical industry. As staff has become more specialist it is important that people without detailed experience in analytical chemistry understand the fundamental principles involved in order to evaluate the data presented to them. This course is intended to provide a firm basis to enable non-analytical chemists to understand and to evaluate the significance of the data generated in the analytical laboratory.
TBA Day Course	The European variations rules & the science behind Lecturer: Dr. Malcolm Ross, Switzerland
	This one day course is designed to address those changes which are related to product and production rather than the administrative changes that are related to labeling or change of address etc. This discusses variations from both the regulatory and the technical side and is designed to provide a deeper understanding of the technical process involved for regulatory and registration officers.
26/05/2009 Day Course	Quality Product Review Lecturer: Ms. Karen Ginsbury
	This one day course will take an in depth look at the regulatory requirements (EU and FDA) for performing quality reviews in the context of Q10 – Pharmaceutical Quality System Guidance which requires Management Review and ongoing product and process performance monitoring, as well in the light of the draft FDA guidance on Process Validation that requires ongoing process verification. Product Annual Review as performed by companies to-date will be a large part of the quality review but this course will review those additional elements that are required in order to remain current with updated regulations and expectations.
25/05/2009 Day Course	GMPs for Printed Packaging Materials Lecturer: Ms. Karen Ginsbury
	The goal of the course is to provide participants with an understanding of the inherent dangers and complexity of handling, managing and controlling printed packaging materials so as to minimize the likelihood of inaccuracies in text, of mix-up of versions and / or of product recall because of packaging or labeling mix-ups.
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	Advanced Methods for Promoting Industry Excellence Lecturer: Dr. Sigalit Arieli-Portnoy
TBA Day Course	Product & Process Lifecycle ICH Q8,Q9,Q10,Q11 Lecturer: Ms. Karen Ginsbury
	This one day seminar will take a novel look at product and process development through marketing in the light of the newest guidances. A draft annex to ICH Q8 has just been issued that provides additional clarification regarding its implementation. Inspectors world-wide are undergoing intensive training and discussions about how to perform Quality by Design (QbD) inspections. Will your company be ready to meet the challenge. These three closely integrated guides are global, consensus guides that are being implemented by EMEA, FDA and worldwide. The course will provide an understanding of the need for the guidances, will review the guidances using case studies to explain how they can be integrated into existing quality systems particularly with a view to QA in R&D.
TBA Day Course	Pharmacopoeias and Compendial Testing of Pharmaceuticals Lecturer: Dr. Raphy Bar
	US and European pharmacopoeias are independent organizations that set the standards for determining the quality of pharmaceutical products marketed in the US or Europe. These standards govern the quality, strength, purity and potency of active pharmaceutical ingredients, dosage forms and excipients as well as many reagents and solutions used to test these materials. USP and Ph.Eur. are legally recognized compendia for regulatory agencies and they are widely used by the pharmaceutical industry. Any pharmaceutical testing laboratory must be capable of applying the tests described in the compendial monographs.
TBA Day Course	Quality assurance on calibration and measurements including the updated requirements according to the new edition of the ISO/IEC/EN17025 standard Lecturer: Mr. Teddy Hoffman
	This course is intended for all the people working in measurements and calibration, including quality managers knowing the basic rules on this domain and desiring to go deeply and to enrich their knowledge on metrology and on the new standards and requirements.
TBA Day Course	Israeli Legislation on the Quality of Drugs and Biologics Lecturers: Dr. Rachel Karpel, Adv. Yoel Lifshitz
TBA 2 - Day Course	Out Of Specification results Lecturer: Ms. Karen Ginsbury
	In October 2006, FDA finalized its "Guidance for Industry: Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production", EIGHT years after issuing the first draft.
TBA Day Course	ICH, EMEA and FDA Guidelines for Drug and Drug-Substances Stability Lecturer: Dr. Rachel Karpel
TBA 3 - Day Course	Registering Your Biologics Product with the FDA Lecturers: Dr. Eli Schmell , Dr. Ruthy Wolfson
	This three day course is a Step by Step guide for registration of a biotechnology product with the US FDA. The course covers all aspects of product registration from a theoretical and practical point of view. Course content and presentation are divided between lectures covering the guidelines and examples of actual registration stages and practical, workshop application by the course participants.
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 2 - Day Course	RCA - Root Cause Analysis Lecturer: Dr. Malcolm Ross, Switzerland
	Participants will learn how the need to undertake investigations in a systematic manner came about. They will learn the philosophies of different systems that are used in various industries such as CAPA, FMEA, PHA and HAZOP and the difference between reactive and proactive systems.
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.
TBA Day Course	GMP / GCP / GLP – The overlap in preparation of material for Preclinical and Clinical Trials Lecturer: Ms. Karen Ginsbury
TBA Day Course	PIC/S Quality Standards for Drugs Lecturer: Dr. Rachel Karpel

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.
16/12/2008 Day Course	Closure manufacture, use & testing Lecturer: Mr. David Williams, UK
	This one-day workshop will provide delegates with the knowledge of how packs are closed to maximise protection of ethical and OTC medicines. A successfully closed pack is a fundamental part of every marketed product and is vital to ensure the success of the product.
01/12/2008 2 - Day Course	Pharmaceutical Microbiology Lecturer: Ms. Karen Ginsbury
TBA 2 - Day Course	Drug Safety Lecturer: Orit Neudorfer, MD
	This course will review the history of drug safety until present days, and describe how safety management has changed its scope to achieve its new challenges. Development of safety strategy, from early development, throughout clinical phases until post-marketing, will be studied, including the establishment of an effective risk management plan.
26/11/2008 Day Course	Managing Calibration Systems as Part of the QA System Lecturers: Dr. Orna Dreazen, Mr. Teddy Hoffman
18/11/2008 Day Course	CAPA and a Product Lifecycle Approach : Ms. Karen Ginsbury
	This course will look at what CAPA really is, how information is gathered and fed into the system and how issues are investigated to address root cause and resolve the issue, to prevent recurrence.
23/09/2008 Day Course	פרמנטציה יישומית בתעשיה הביוטכנולוגית והביופרמצבטית Lecturer: Mr. Moshe Landsberg
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.
06/08/2008 Day Course	Analytical Instrument Qualification - AIQ Lecturer: Ms. Karen Ginsbury
	This one day seminar will review the USP Chapter on Analytical Instrument Qualification (AIQ) in the perspective of regulatory requirements (EU and FDA), guidance and expectations.
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.
07/07/2008 2 - Day Course	Technology Transfer Lecturer: Dr. Malcolm Ross, Switzerland
17/06/2008 Day Course	דה-פירוגנציה Lecturer: Mr. Eliezer Solomon
11/06/2008 Day Course	Validation of Analytical Methods Lecturer: Dr. Hagit Yariv
12/05/2008 3 - Day Course	Developing Clinical Quality Assurance Audit Skills and Procedures (CQA) Lecturer: Mr. Steve Schwartz
	Roles and Responsibilities for Auditors and Managers
14/04/2008 Day Course	GMP Aspects of Analytical Quality Control including OOS results Lecturer: Ms. Karen Ginsbury
	The Quality Control Laboratory is consistently featuring at the top of the deficiency lists in regulatory inspections. This is a chance to be up-dated and to minimize the chance of adverse inspectional outcome in your laboratory.
07/04/2008 2 - Day Course	RCA - Root Cause Analysis Lecturer: Dr. Malcolm Ross, Switzerland
	Participants will learn how the need to undertake investigations in a systematic manner came about. They will learn the philosophies of different systems that are used in various industries such as CAPA, FMEA, PHA and HAZOP and the difference between reactive and proactive systems.
31/03/2008 Day Course	Listen to the Voice of Process - Control charts for use in establishing manufacturing processes stability Lecturer: Dr. Judah Lando
28/01/2008 Day Course	Qualification and Validation of Pharmaceutical Equipment Lecturer: Ms. Karen Ginsbury
	The course will be delivered in Hebrew

2007

25/12/2007 Day Course	The Microbiology of Environmental Monitoring (EM) Lecturer: Ms. Karen Ginsbury
18/09/2007 Day Course	CAPA & Handling Investigations Lecturer: Ms. Karen Ginsbury
	This course will look at what CAPA really is, how information is gathered and fed into the system and how issues are investigated to address root cause and resolve the issue, preventing recurrence. This course will help your company develop an escalation policy (addressed in Q10) to take unresolved items through the management hierarchy to ensure resolution.
07/06/2007 Day Course	GTP - Good Tissue Practice Lecturer: Ms. Eliane Schutte, the Netherlands
	At the end of the one day-seminar participants will have an in-depth knowledge of the FDA Current Good Tissue Practice and understand the key critical items.
29/05/2007 Day Course	Pharmaceutical Microbiology Lecturer: Ms. Karen Ginsbury
	This one day course will take an in depth look at the regulatory requirements (EU and FDA) for microbiological control of pharmaceuticals. This topic is receiving greater scrutiny in regulatory inspections and becoming of ever-increasing importance to the regulators.
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
18/10/2006 Day Course	Quality Assurance in the QC Laboratory Lecturer: Ms. Karen Ginsbury
09/09/2006 2 - Day Course	GMP in Production of Phase I Clinical Trial Materials Lecturer: Karen Ginsbury
16/05/2006 2 - Day Course	Process Validation Lecturer: Dr. Eli Schmell
09/03/2006 Day Course	Compliance and Passing Inspections Lecturer: Karen Ginsbury
30/01/2006 Day Course	Implementation of the Quality System Regulation - QSR for manufacture and control of medical devices Lecturer: Karen Ginsbury

2005

07/09/2005 2 - Day Course	The Microbiology of Environmental Monitoring (EM) Lecturer: Karen Ginsbury