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Manufacturing |
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Upcoming
2011
2010
06/10/2010
Day Course
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Product Lifecycle and Product Control Strategy - ICH Q8, Q9, Q10
Lecturer: Ms. Karen Ginsbury
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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. |
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12/10/2010
Day Course
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Process Analytical Technology – PAT (Beginners)
Lecturer: Dr. Yehuda Shekel
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12/10/2010
Day Course
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Introduction to production of solid dosage forms
Lecturer: Mr. Eran Yona
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13/10/2010
2 - Day Course
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Uncertainty in calibration and measurements
Lecturer: Mr. Teddy Hoffman
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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. |
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20/10/2010
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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20/10/2010
3 - Day Course
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CIP Technology
Lecturer: Mr. Moshe Landsberg
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26/10/2010
Day Course
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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
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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. |
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03/11/2010
Day Course
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Product Quality Review as a Tool for Continued Process Verification
Lecturer: Ms. Karen Ginsbury
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09/11/2010
3 - Day Course
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Process Validation
Lecturer: Dr. Eli Schmell
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09/11/2010
3 - Day Course
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HPLC Method Development
Lecturers: Prof. Eli Grushka, Dr. Igal Bar-Ilan
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10/11/2010
Day Course
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Extractables and Leachables from containers/closures of drugs and from devices
Lecturer: Dr. Raphy Bar
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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. |
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16/11/2010
3 - Day Course
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Stabilization of Proteins and Peptides along the Formulation Process
Lecturer: Dr. Mark Cornell Manning
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22/11/2010
2 - Day Course
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Solid Dosage Manufacturing Process
Lecturer: Mr. Michael Tousey, USA
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24/11/2010
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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30/11/2010
Day Course
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Cleaning Validation
Lecturer: Ms. Karen Ginsbury
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14/12/2010
2 - Day Course
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Sterilization by Radiation
Lecturer: Mr. Martell Winters
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21/12/2010
2 - Day Course
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Design of Sterile and Aseptic Production systems
Lecturer: Mr. Shlomo Sackstein
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Past Activities
2010
TBA
Day Course
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Preventing and Coping with Problems in a Multi-Disciplinary Work Environment
Lecturer: Mr. Yoav Gavrieli
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TBA
Day Course
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Pharmaceutical Micro-organisms: Sources, Control Strategies, Isolation, Identification, Challenging, Storage and Handling
Lecturer: Ms. Karen Ginsbury
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TBA
Day Course
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Environmental Monitoring
Lecturer: Ms. Karen Ginsbury
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TBA
2 - Day Course
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Microbiological Best Laboratory Practices
Lecturer: Ms. Karen Ginsbury
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TBA
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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TBA
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
3 - Day Course
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Introduction to GMP and Quality Assurance for Manufacture and Control of Finished Pharmaceuticals
Lecturer: Ms. Karen Ginsbury
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Participants will graduate this course with an understanding of the GMP regulations and an idea of how and why they need to be implemented |
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TBA
3 - Day Course
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Workshop - GMP in a Clean Room Facility
Lecturers: Dr. Moti Yizhar, Dr. Rasooly
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08/06/2010
Day Course
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Managing Calibration Systems as Part of the QA System
Lecturers: Dr. Orna Dreazen, Mr. Teddy Hoffman
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26/05/2010
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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04/05/2010
Day Course
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Cost Effective Manufacturing in tablet production
Lecturer: Mr. Michael Tousey
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29/04/2010
Day Course
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Technology Transfer of Analytical Methods
Lecturer: Dr. Raphy Bar
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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. |
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28/04/2010
Day Course
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Phase Appropriate GMP for Investigational Products
Lecturer: Ms. Karen Ginsbury
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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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24/03/2010
2 - Day Course
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RCA - Root Cause Analysis
Lecturer: Dr Malcolm Ross
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22/03/2010
Day Course
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Conducting, Documenting and Ensuring Effective Investigations
Lecturers: Ms. Karen Ginsbury, Dr. Rachel Karpel
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At the end of this course participants will understand how to effectively investigate deviations and untoward events. |
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TBA
Day Course
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Audits of Medical Devices - Implementation of the ISO 13485:2003
Lecturer: Ms. Rita Gabay
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16/02/2010
2 - Day Course
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Water Systems in the Pharmaceutical & Biotechnological Industries
Lecturer:
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08/02/2010
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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20/01/2010
Day Course
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Engineering as the Foundation of the Pharmaceutical Industry
Professional management: Eng. David Carmon
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19/01/2010
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
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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2009
TBA
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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TBA
2 - Day Course
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Powder Technology - The Missing Link in Solid Dosage Formulation
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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09/12/2009
2 - Day Course
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Technology Transfer
Lecturer: Dr Malcolm Ross, Switzerland
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15/11/2009
3 - Day Course
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GMP in a Clean Room Facility
Lecturers: Dr. Moti Yizhar, Dr. Rasooly
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TBA
Day Course
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Listen to the Voice of Process - Control charts for use in establishing manufacturing processes stability
Lecturer: Dr. Judah Lando
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14/09/2009
Day Course
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Introduction to production of solid dosage forms
Lecturer: Mr. Eran Yona
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12/08/2009
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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10/08/2009
3 - Day Course
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Introduction to GMP and Quality Assurance for manufacture and control of Finished Pharmaceuticals
Lecturer: Ms. Karen Ginsbury
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Participants will graduate this course with an understanding of the GMP regulations and an idea of how and why they need to be implemented |
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07/07/2009
Day Course
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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
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TBA
2 - Day Course
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Process Scale-Up - Advanced Level
Lecturer: Ariel Ewenson, Ph.D
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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
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
Day Course
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Advanced Methods for Promoting Industry Excellence
Lecturer: Dr. Sigalit Arieli-Portnoy
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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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Sterilization by Radiation
Lecturer: Mr. Martell Winters, USA
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24/02/2009
4 Meetings
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Introduction to Scale-Up
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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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TBA
3 - Day Course
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Analytical Chemistry in the Pharmaceutical Raw Material Laboratory
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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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11/02/2009
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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05/02/2009
Day Course
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Analytical Methods - Technology Transfer & Verification
Lecturer: Dr. Raphy Bar
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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. |
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TBA
Day Course
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GMP / GCP / GLP – The overlap in preparation of material for Preclinical and Clinical Trials
Lecturer: Ms. Karen Ginsbury
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2008
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
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
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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01/12/2008
2 - Day Course
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Pharmaceutical Microbiology
Lecturer: Ms. Karen Ginsbury
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26/11/2008
Day Course
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Managing Calibration Systems as Part of the QA System
Lecturers: Dr. Orna Dreazen, Mr. Teddy Hoffman
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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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23/09/2008
Day Course
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פרמנטציה יישומית בתעשיה הביוטכנולוגית והביופרמצבטית
Lecturer: Mr. Moshe Landsberg
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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
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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TBA
2 - Day Course
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Operation Excellence in the Pharmaceutical Industry
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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07/07/2008
2 - Day Course
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Technology Transfer
Lecturer: Dr. Malcolm Ross, Switzerland
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17/06/2008
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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31/03/2008
Day Course
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Listen to the Voice of Process - Control charts for use in establishing manufacturing processes stability
Lecturer: Dr. Judah Lando
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2007
2006
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