04/06/2013 יום לימודים מלא Managing Calibration Systems as Part of the QA System Lecturers: Dr. Orna Dreazen, Mr. Teddy Hoffman

18/06/2013 יום לימודים מלא Good Weighing Procedures Lecturer: Mr. Gidi Wilenski, Mr. Shai Lavi

19/06/2013 2 מפגשים, יום שלם Fermentation Lecturer: Mr. Moshe Landsberg

24/06/2013 יום לימודים מלא Disinfectant Qualification & Cleaning Procedures Lecturer: Mrs. Ziva Abraham

01/07/2013 יום לימודים מלא ניהול וביצוע יעילים של חקירות-כשל בתהליכי הייצור הפרמצבטי Lecturer: Dr. Tanya Gershnik

01/07/2013 3 ימי לימודים מלאים Water Systems in the Pharmaceutical & Biotechnological Industries Lecturer: Mr Moshe Landsberg

02/07/2013 יום לימודים מלא Implementation of Worst Case Approach In Cleaning Validation Systems Lecturer: Mr. Effi Amir

10/07/2013 2 ימי לימודים מלאים Environmental Monitoring Lecturer: Ms. Karen Ginsbury

29/07/2013 2 ימי לימודים מלאים PAT, NIR and QBD Lecturer: Dr. Mark Howard, USA   Advanced Course

16/10/2013 יום לימודים מלא System & Equipment Qualification & Validation Lecturer: Ms. Karen Ginsbury   Including case-studies, handling deviations (+ a sneak peep at the FDA Process Validation Draft)

28/10/2013 יום לימודים מלא Process Analytical Technology – PAT (Beginners) Lecturer: Dr. Yehuda Shekel

14/11/2013 יום לימודים מלא 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

19/11/2013 יום לימודים מלא 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

15/12/2013 2 ימי לימודים מלאים Solid Dosage Form Development – a QbD Approach Lecturer: Dr. Malcolm Ross, Switzerland

יפורסם בהמשך 2 ימי לימודים מלאים Biocompatibility Evaluation of Medical Devices & Biomaterials Lecturer: Dr. Shayne Gad

יפורסם בהמשך 2 ימי לימודים מלאים 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

יפורסם בהמשך 2 ימי לימודים מלאים Process Scale-Up - Advanced Level Lecturer: Ariel Ewenson

יפורסם בהמשך 2 ימי לימודים מלאים Capsule Technology & Encapsulation of Commercial & Clinical Supplies Lecturer: Mr. Donald K. Lightfoot, USA   A comprehensive capsule technology presentation covering the manufacturing of empty and filled two piece capsules, fundamentals of encapsulation, blinding of clinical supplies utilizing over-encapsulation and an extensive review of the encapsulation machinery and equipment.

יפורסם בהמשך 3 ימי לימודים מלאים Sample Preparation - Introduction Lecturer: Prof. Eli Grushka

יפורסם בהמשך יום לימודים מלא Introduction to production of solid dosage forms Lecturer: Mr. Eran Yona

יפורסם בהמשך יום לימודים מלא Listen to the Voice of Process - Control charts for use in establishing manufacturing processes stability Lecturer: Dr. Judah Lando

17/03/2013 2 ימי לימודים מלאים RCA - Root Cause Analysis Lecturer: Dr Malcolm Ross

13/03/2013 יום לימודים מלא 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.

יפורסם בהמשך 3 ימי לימודים מלאים Process Validation Lecturer: Dr. Eli Schmell

יפורסם בהמשך יום לימודים מלא Engineering of Compressed Air Systems for Pharma and Biotech Industןies Lecturer: Mr. Shlomo Sackstein

יפורסם בהמשך 3 ימי לימודים מלאים Workshop - GMP in a Clean Room Facility Lecturers: Dr. Moti Yizhar, Dr. Rasooly

יפורסם בהמשך 2 ימי לימודים מלאים Sterilization by Ethylene Oxide Lecturer: Mr. Daniel Floyd

16/01/2013 יום לימודים מלא Lyophilisation – Freez-drying Machines Lecturer: Mr. Arie Elster

07/01/2013 2 ימי לימודים מלאים 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.

יפורסם בהמשך 2 מפגשים, יום שלם Powder Technology - The Missing Link in Solid Dosage Formulation Lecturer: Dr. Malcolm Ross, Switzerland   The course will concentrate on solid dosage forms but some mention will be made of other dosage form designs where particle size is critical.

04/12/2012 2 ימי לימודים מלאים Design of Sterile and Aseptic Production Systems Lecturer: Mr. Shlomo Sackstein

27/11/2012 3 ימי לימודים מלאים HPLC Method Development Lecturers: Prof. Eli Grushka, Dr. Igal Bar-Ilan

20/11/2012 2 ימי לימודים מלאים Water Systems in the Pharmaceutical & Biotechnological Industries Lecturer: Mr Moshe Landsberg

יפורסם בהמשך 2 ימי לימודים מלאים Sterilization by Radiation Lecturer: Mr. Martell Winters

29/10/2012 2 ימי לימודים מלאים HVAC Systems Lecturers: Ms. Karen Ginsbury, Mr. 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.

23/10/2012 יום לימודים מלא Validation of USP / EP Sterility Test Lecturer: Mr. Alexander Gulkarov

21/10/2012 יום לימודים מלא למידת גורמי האנוש בניתוח אירועי איכות ובטיחות Lecturer: Mr. Menachem Horev

יפורסם בהמשך 2 ימי לימודים מלאים Sterilization by ETO, basic level Lecturer: Dr. Yeshayahu Ya'akovi

08/08/2012 יום לימודים מלא Appling Risk Management Approach in Cross Contamination Lecturer: Mrs. Yifat Litan

02/08/2012 יום לימודים מלא 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.

03/07/2012 3 ימי לימודים מלאים CIP Technology Lecturer: Mr. Moshe Landsberg

21/06/2012 יום לימודים מלא Cleaning Validation Lecturer: Ms. Karen Ginsbury

30/05/2012 יום לימודים מלא 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

17/05/2012 יום לימודים מלא Phase Appropriate GMP for Investigational Products Lecturer: Ms. Karen Ginsbury

17/05/2012 יום לימודים מלא בקרת מזיקים בתעשייה Lecturer: Mr. אלי לוגסי

28/03/2012 2 ימי לימודים מלאים Technology Transfer Lecturer: Dr. Malcolm Ross, Switzerland

22/02/2012 3 ימי לימודים מלאים Analytical Chemistry in the Pharmaceutical Raw Material Laboratory Lecturer: Dr. Rivka Goldik   The purpose of this seminar is to deepen the knowledge and awareness of the tests performed in the raw material laboratory and to increase the ability of performance and the product's quality, as well as to decrease misleading and to obtain the ability to predict and solve problems.

20/02/2012 2 ימי לימודים מלאים Rheology for Chemists Lecturer: Mr Neil Cunningham, UK   Rheology for Chemists is an accessible but comprehensive introduction to the principles and practical application of rheological and viscometric techniques for R&D, quality control and process development needs. The course will benefit anybody looking to obtain relevant, repeatable information on the flow behavior of suspensions, emulsions, solutions, gels and waxes. The two day course comprises lectures, QA sessions and some practical demonstrations of current popular techniques and test equipment.

13/02/2012 יום לימודים מלא ניהול וביצוע יעילים של חקירות-כשל בתהליכי הייצור הפרמצבטי Lecturer: Ms. Yehudith Wexler

09/02/2012 יום לימודים מלא 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

יפורסם בהמשך יום לימודים מלא 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.

יפורסם בהמשך 3 ימי לימודים מלאים Process Validation Lecturer: Dr. Eli Schmell

12/12/2011 יום לימודים מלא Managing Calibration Systems as Part of the QA System Lecturers: Dr. Orna Dreazen, Mr. Teddy Hoffman

14/11/2011 יום לימודים מלא 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.

31/10/2011 3 ימי לימודים מלאים Workshop - GMP in a Clean Room Facility Lecturers: Dr. Moti Yizhar, Dr. Rasooly

04/10/2011 יום לימודים מלא Lyophilisation – Freez-drying Machines Lecturer: Mr. Arie Elster

08/08/2011 2 ימי לימודים מלאים Water Systems in the Pharmaceutical & Biotechnological Industries Lecturer:

03/08/2011 2 ימי לימודים מלאים Microbiological Best Laboratory Practices Lecturer: Ms. Karen Ginsbury

18/07/2011 יום לימודים מלא Engineering of Compressed Air Systems for Pharma and Biotech Industןies Lecturer: Mr. Shlomo Sackstein

יפורסם בהמשך 2 ימי לימודים מלאים Creating and Managing an Intranet Portal as a Knowledge Mangement Tool Lecturer: Dr. Nava Rotem

יפורסם בהמשך יום לימודים מלא דה-פירוגנציה Lecturer: Mr. Eliezer Solomon

יפורסם בהמשך 3 ימי לימודים מלאים Hazop Leaders :

25/05/2011 3 ימי לימודים מלאים CIP Technology Lecturer: Mr. Moshe Landsberg

04/04/2011 2 ימי לימודים מלאים Sterilization by Radiation Lecturer: Mr. Martell Winters

29/03/2011 יום לימודים מלא Listen to the Voice of Process - Control charts for use in establishing manufacturing processes stability Lecturer: Dr. Judah Lando

15/03/2011 2 ימי לימודים מלאים Design of Sterile and Aseptic Production Systems Lecturer: Mr. Shlomo Sackstein

23/02/2011 יום לימודים מלא Validation of USP / EP Sterility Test Lecturer: Mr. Alexander Gulkarov

22/02/2011 יום לימודים מלא 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.

09/02/2011 יום לימודים מלא Developing Structured, Robust and Repeatable Scale-up Processes :

08/02/2011 יום לימודים מלא On-line Control and Supervision Along the Supply Chain :

07/02/2011 יום לימודים מלא Developing Efficient Communication Between QC Labs and Production Staff Lecturer: Dr. Sigalit Arieli-Portnoy

יפורסם בהמשך יום לימודים מלא 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.

יפורסם בהמשך 2 ימי לימודים מלאים Solid Dosage Manufacturing Process Lecturer: Mr. Michael Tousey, USA

05/01/2011 יום לימודים מלא Cleaning Validation Lecturer: Ms. Karen Ginsbury

03/01/2011 2 ימי לימודים מלאים Sterilization by ETO, basic level Lecturer: Dr. Yeshayahu Ya'akovi

16/11/2010 3 ימי לימודים מלאים Stabilization of Proteins and Peptides along the Formulation Process Lecturer: Dr. Mark Cornell Manning, USA

יפורסם בהמשך 3 ימי לימודים מלאים Process Validation Lecturer: Dr. Eli Schmell

09/11/2010 3 ימי לימודים מלאים HPLC Method Development Lecturers: Prof. Eli Grushka, Dr. Igal Bar-Ilan

26/10/2010 יום לימודים מלא 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.

20/10/2010 יום לימודים מלא 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.

12/10/2010 יום לימודים מלא Process Analytical Technology – PAT (Beginners) Lecturer: Dr. Yehuda Shekel

יפורסם בהמשך יום לימודים מלא Pharmaceutical Micro-organisms: Sources, Control Strategies, Isolation, Identification, Challenging, Storage and Handling Lecturer: Ms. Karen Ginsbury

יפורסם בהמשך 2 ימי לימודים מלאים Microbiological Best Laboratory Practices Lecturer: Ms. Karen Ginsbury

יפורסם בהמשך יום לימודים מלא 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.

יפורסם בהמשך 3 ימי לימודים מלאים Workshop - GMP in a Clean Room Facility Lecturers: Dr. Moti Yizhar, Dr. Rasooly

08/06/2010 יום לימודים מלא Managing Calibration Systems as Part of the QA System Lecturers: Dr. Orna Dreazen, Mr. Teddy Hoffman

26/05/2010 יום לימודים מלא 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.

04/05/2010 יום לימודים מלא Cost Effective Manufacturing in tablet production Lecturer: Mr. Michael Tousey

28/04/2010 יום לימודים מלא Phase Appropriate GMP for Investigational Products Lecturer: Ms. Karen Ginsbury

12/04/2010 2 ימי לימודים מלאים 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 ימי לימודים מלאים RCA - Root Cause Analysis Lecturer: Dr Malcolm Ross

22/03/2010 יום לימודים מלא 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.

16/02/2010 2 ימי לימודים מלאים Water Systems in the Pharmaceutical & Biotechnological Industries Lecturer:

08/02/2010 יום לימודים מלא 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.

20/01/2010 יום לימודים מלא Engineering as the Foundation of the Pharmaceutical Industry Professional management: Eng. David Carmon

19/01/2010 יום לימודים מלא GMP עיקור בסביבת Professional management: Ms. Yehudith Wexler   Isranalytica 2010 – Related Events

יפורסם בהמשך יום לימודים מלא 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.

יפורסם בהמשך יום לימודים מלא 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.

יפורסם בהמשך 2 ימי לימודים מלאים Powder Technology - The Missing Link in Solid Dosage Formulation Lecturer: Dr. Malcolm Ross, Switzerland   The course will concentrate on solid dosage forms but some mention will be made of other dosage form designs where particle size is critical.

09/12/2009 2 ימי לימודים מלאים Technology Transfer Lecturer: Dr. Malcolm Ross, Switzerland

15/11/2009 3 ימי לימודים מלאים GMP in a Clean Room Facility Lecturers: Dr. Moti Yizhar, Dr. Rasooly

יפורסם בהמשך יום לימודים מלא Listen to the Voice of Process - Control charts for use in establishing manufacturing processes stability Lecturer: Dr. Judah Lando

14/09/2009 יום לימודים מלא Introduction to production of solid dosage forms Lecturer: Mr. Eran Yona

12/08/2009 יום לימודים מלא 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 ימי לימודים מלאים 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

07/07/2009 יום לימודים מלא 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

יפורסם בהמשך 2 ימי לימודים מלאים Process Scale-Up - Advanced Level Lecturer: Ariel Ewenson, Ph.D

03/06/2009 2 ימי לימודים מלאים 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.

25/05/2009 יום לימודים מלא 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.

25/05/2009 2 ימי לימודים מלאים Managing Extractables and Leachables in Pharmaceutical Products Lecturer: Ph.D. Edward J. Smith   This course will review guidance documents, and other regulations regarding the identification, measurement, toxicological qualification, and reporting of extractables/leachables from packaging and process materials into pharmaceutical and biotech products. Included in the course is a detailed discussion of the sources of extractables from glass, rubber, and plastic packaging and process components and the work of the Product Quality Research Institute (PQRI) on inhalation, ophthalmic, and parenteral products. Examples will also be presented to demonstrate how E&L issues can be mitigated through the judicious choice of packaging components and materials.

04/05/2009 2 ימי לימודים מלאים Capsule Technology & Encapsulation of Commercial & Clinical Supplies Lecturer: Mr. Donald K. Lightfoot, USA   A comprehensive capsule technology presentation covering the manufacturing of empty and filled two piece capsules, fundamentals of encapsulation, blinding of clinical supplies utilizing over-encapsulation and an extensive review of the encapsulation machinery and equipment.

יפורסם בהמשך יום לימודים מלא Advanced Methods for Promoting Industry Excellence Lecturer: Dr. Sigalit Arieli-Portnoy

יפורסם בהמשך 2 ימי לימודים מלאים 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.

יפורסם בהמשך 2 ימי לימודים מלאים Sterilization by Radiation Lecturer: Mr. Martell Winters, USA

24/02/2009 4 מפגשים, חצי יום Introduction to Scale-Up :

יפורסם בהמשך 2 ימי לימודים מלאים 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.

11/02/2009 יום לימודים מלא 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.

יפורסם בהמשך יום לימודים מלא GMP / GCP / GLP – The overlap in preparation of material for Preclinical and Clinical Trials Lecturer: Ms. Karen Ginsbury

17/12/2008 2 ימי לימודים מלאים Pharmaceutical Packaging Technology Lecturer: Mr. David Williams, UK   This intensive course will provide delegates with the knowledge of how packs, for packaging of ethical, OTC and veterinary medicines, are developed, manufactured, filled, transported, stored and used. Packaging is a fundamental part of every marketed product and frequently is fundamental in the success of the product.

17/12/2008 יום לימודים מלא 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 יום לימודים מלא 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 ימי לימודים מלאים Pharmaceutical Microbiology Lecturer: Ms. Karen Ginsbury

26/11/2008 יום לימודים מלא Managing Calibration Systems as Part of the QA System Lecturers: Dr. Orna Dreazen, Mr. Teddy Hoffman

18/11/2008 2 ימי לימודים מלאים Rheology for Chemists Lecturer: Mr Neil Cunningham, UK   Rheology for Chemists is an accessible but comprehensive introduction to the principles and practical application of rheological and viscometric techniques for R&D, quality control and process development needs. The course will benefit anybody looking to obtain relevant, repeatable information on the flow behavior of suspensions, emulsions, solutions, gels and waxes. The two day course comprises lectures, QA sessions and some practical demonstrations of current popular techniques and test equipment.

23/09/2008 יום לימודים מלא פרמנטציה יישומית בתעשיה הביוטכנולוגית והביופרמצבטית Lecturer: Mr. Moshe Landsberg

15/07/2008 2 ימי לימודים מלאים Tablet Process Development and Quality by Design Lecturer: Dr Michael Gamlen, UK   The course includes a review of all key tablet manufacturing processes and their critical parameters with special emphasis on blending, in-process testing, and granulation. All participants take part in an interactive workshop on the principles and application of Quality by Design and Process Analytical Technology (PAT).

יפורסם בהמשך 2 ימי לימודים מלאים Efficient Management in Quality Operation 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 ימי לימודים מלאים Technology Transfer Lecturer: Dr. Malcolm Ross, Switzerland

17/06/2008 יום לימודים מלא דה-פירוגנציה Lecturer: Mr. Eliezer Solomon

04/06/2008 2 ימי לימודים מלאים Powder Technology - The Missing Link Lecturer: Dr. Malcolm Ross, Switzerland   The course will concentrate on solid dosage forms but some mention will be made of other dosage form designs where particle size is critical.

31/03/2008 יום לימודים מלא Listen to the Voice of Process - Control charts for use in establishing manufacturing processes stability Lecturer: Dr. Judah Lando

25/12/2007 יום לימודים מלא PAT- Process Analytical Technology In a Regulated Environment Lecturer: Dr. Mark Howard, Dr. Yehuda Shekel   The course will concentrate on the way the organization should tailor its analytical approach in order to apply it to process measurement and control in a regulated environment.

21/03/2006 יום לימודים מלא Validation of Ethylene Oxide (EtO) Sterilisation Lecturer: Shira Rozenberg