Manufacturing

Upcoming

2011

TBA 2 - Day Course	Biocompatibility Evaluation of Medical Device & Biomaterials Lecturer: Dr. Shayne Gad
	The goal of this course is to enable you to develop new medical devices faster, more efficiently and with less expense by giving you a practical working knowledge of biocompatibility and device development.
TBA Day Course	Efficient Management in Quality Operation Lecturer: Mr. Rafi Maslaton
TBA 2 - Day Course	Sterilization by Ethylene Oxide Lecturer: Mr. Daniel Floyd
TBA 2 - Day Course	Creating and Managing an Intranet Portal as a Knowledge Mangement Tool Lecturer: Dr. Nava Rotem
TBA 2 - Day Course	Process Scale-Up - Advanced Level Lecturer: Ariel Ewenson
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.

2010

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.
12/10/2010 Day Course	Process Analytical Technology – PAT (Beginners) Lecturer: Dr. Yehuda Shekel
12/10/2010 Day Course	Introduction to production of solid dosage forms Lecturer: Mr. Eran Yona
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
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.
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
09/11/2010 3 - Day Course	HPLC Method Development Lecturers: Prof. Eli Grushka, Dr. Igal Bar-Ilan
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.
16/11/2010 3 - Day Course	Stabilization of Proteins and Peptides along the Formulation Process Lecturer: Dr. Mark Cornell Manning
22/11/2010 2 - Day Course	Solid Dosage Manufacturing Process Lecturer: Mr. Michael Tousey, USA
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
14/12/2010 2 - Day Course	Sterilization by Radiation Lecturer: Mr. Martell Winters
21/12/2010 2 - Day Course	Design of Sterile and Aseptic Production systems Lecturer: Mr. Shlomo Sackstein

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.
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
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
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
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.
04/05/2010 Day Course	Cost Effective Manufacturing in tablet production Lecturer: Mr. Michael Tousey
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
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
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.
20/01/2010 Day Course	Engineering as the Foundation of the Pharmaceutical Industry Professional management: Eng. David Carmon
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	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.
TBA 2 - Day Course	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 - 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
TBA Day Course	Listen to the Voice of Process - Control charts for use in establishing manufacturing processes stability Lecturer: Dr. Judah Lando
14/09/2009 Day Course	Introduction to production of solid dosage forms Lecturer: Mr. Eran Yona
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
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
TBA 2 - Day Course	Process Scale-Up - Advanced Level Lecturer: Ariel Ewenson, Ph.D
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.
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.
25/05/2009 2 - Day Course	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 - Day Course	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.
TBA Day Course	Advanced Methods for Promoting Industry Excellence Lecturer: Dr. Sigalit Arieli-Portnoy
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 2 - Day Course	Sterilization by Radiation Lecturer: Mr. Martell Winters, USA
24/02/2009 4 Meetings	Introduction to Scale-Up :
TBA 2 - Day Course	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.
TBA 3 - Day Course	Analytical Chemistry in the Pharmaceutical Raw Material Laboratory :
	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.
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.
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

2008

17/12/2008 2 - Day Course	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 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
26/11/2008 Day Course	Managing Calibration Systems as Part of the QA System Lecturers: Dr. Orna Dreazen, Mr. Teddy Hoffman
18/11/2008 2 - Day Course	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 Day Course	פרמנטציה יישומית בתעשיה הביוטכנולוגית והביופרמצבטית Lecturer: Mr. Moshe Landsberg
15/07/2008 2 - Day Course	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).
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
04/06/2008 2 - Day Course	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 Day Course	Listen to the Voice of Process - Control charts for use in establishing manufacturing processes stability Lecturer: Dr. Judah Lando

2007

2006

21/03/2006 Day Course	Validation of Ethylene Oxide (EtO) Sterilisation Lecturer: Shira Rozenberg