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19/06/2013
2 Meetings
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Fermentation
Lecturer: Mr. Moshe Landsberg
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29/07/2013
2 - Day Course
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PAT, NIR and QBD
Lecturer: Dr. Mark Howard, USA
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Advanced Course |
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14/11/2013
1 - Day Course
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Writing SOPs - Workshop
Lecturer: Ms. Karen Ginsbury
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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 |
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TBA
2 - Day Course
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Capsule Technology & Encapsulation of Commercial & Clinical Supplies
Lecturer: Mr. Donald K. Lightfoot, USA
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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. |
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29/10/2012
2 - Day Course
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HVAC Systems
Lecturers: Ms. Karen Ginsbury, Mr. Uri Harel
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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. |
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03/07/2012
3 - Day Course
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CIP Technology
Lecturer: Mr. Moshe Landsberg
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22/02/2012
3 - Day Course
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Analytical Chemistry in the Pharmaceutical Raw Material Laboratory
Lecturer: Dr. Rivka Goldik
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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. |
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20/02/2012
2 - Day Course
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Rheology for Chemists
Lecturer: Mr Neil Cunningham, UK
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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. |
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09/02/2012
1 - Day Course
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Writing SOPs - Workshop
Lecturer: Ms. Karen Ginsbury
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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 |
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TBA
1 - Day Course
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Efficiency in Quality Operation & Managing Batch Records
Lecturer: Mr. Rafi Maslaton - USA
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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. |
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14/11/2011
1 - Day Course
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System & Equipment Qualification & Validation
Lecturer: Ms. Karen Ginsbury
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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. |
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TBA
1 - Day Course
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דה-פירוגנציה
Lecturer: Mr. Eliezer Solomon
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25/05/2011
3 - Day Course
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CIP Technology
Lecturer: Mr. Moshe Landsberg
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TBA
1 - Day Course
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Tablet Pro
Lecturer: Mr. Michael Tousey, USA
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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. |
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20/10/2010
1 - Day Course
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GMPs for Printed Packaging Materials
Lecturer: Ms. Karen Ginsbury
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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. |
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TBA
1 - Day Course
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CAPA & Q10
Lecturer: Ms. Karen Ginsbury
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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. |
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26/05/2010
1 - Day Course
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System & Equipment Qualification & Validation
Lecturer: Ms. Karen Ginsbury
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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. |
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12/04/2010
2 - Day Course
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HVAC Systems
Lecturers: Ms. Karen Ginsbury , Uri Harel
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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. |
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08/02/2010
1 - Day Course
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Change Management According to the Q10 Guidelines
Lecturer: Ms. Karen Ginsbury
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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. |
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19/01/2010
1 - Day Course
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GMP עיקור בסביבת
Professional management: Ms. Yehudith Wexler
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Isranalytica 2010 – Related Events |
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TBA
1 - Day Course
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Auditing Manufacturers of Starting Materials
Lecturer: Ms. Karen Ginsbury
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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. |
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TBA
1 - Day Course
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Multiproduct or Dedicated Facilities
Lecturers: Ms. Karen Ginsbury
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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.
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12/08/2009
1 - Day Course
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Writing Standard Operating Procedures (SOPs) Workshop
Lecturer: Ms. Karen Ginsbury
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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 |
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03/06/2009
2 - Day Course
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Analytical Chemistry for non-analytical chemists
Lecturer: Dr. Malcolm Ross, Switzerland
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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. |
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25/05/2009
1 - Day Course
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GMPs for Printed Packaging Materials
Lecturer: Ms. Karen Ginsbury
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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. |
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25/05/2009
2 - Day Course
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Managing Extractables and Leachables in Pharmaceutical Products
Lecturer: Ph.D. Edward J. Smith
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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. |
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04/05/2009
2 - Day Course
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Capsule Technology & Encapsulation of Commercial & Clinical Supplies
Lecturer: Mr. Donald K. Lightfoot, USA
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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. |
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TBA
2 - Day Course
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Out Of Specification results
Lecturer: Ms. Karen Ginsbury
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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. |
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TBA
2 - Day Course
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Ethylene Oxide Sterilization
Lecturer: Mr. Daniel Floyd, USA
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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. |
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11/02/2009
1 - Day Course
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Risk Management Strategy Planning
Lecturer: Dr. Malcolm Ross, Switzerland
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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. |
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17/12/2008
2 - Day Course
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Pharmaceutical Packaging Technology
Lecturer: Mr. David Williams, UK
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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. |
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17/12/2008
1 - Day Course
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GMPs in the Manufacture of Clinical Trials Material
Lecturer: Ms. Karen Ginsbury
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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. |
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16/12/2008
1 - Day Course
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Closure manufacture, use & testing
Lecturer: Mr. David Williams, UK
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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. |
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18/11/2008
2 - Day Course
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Rheology for Chemists
Lecturer: Mr Neil Cunningham, UK
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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. |
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15/07/2008
2 - Day Course
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Tablet Process Development and Quality by Design
Lecturer: Dr Michael Gamlen, UK
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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). |
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TBA
2 - Day Course
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Efficient Management in Quality Operation
Lecturer: Mr. Rafi Maslaton, USA
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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. |
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17/06/2008
1 - Day Course
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דה-פירוגנציה
Lecturer: Mr. Eliezer Solomon
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04/06/2008
2 - Day Course
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Powder Technology - The Missing Link
Lecturer: Dr. Malcolm Ross, Switzerland
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The course will concentrate on solid dosage forms but some mention will be made of other dosage form designs where particle size is critical. |
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