חיפוש קורסים לפי נושא



מנוי

מומחים מחו"ל

דף הבית :: כל הקורסים מספר קורסים: 110

ארועים עתידיים

2019

18/12/2019
2 ימי לימודים מלאים
RCA - Root Cause Analysis
Lecturer: Dr Malcolm Ross
 

2020

27/01/2020
2 ימי לימודים מלאים
Biocompatibility Evaluation and Risk Assessment of Medical Devices
to Current ISO 10993 2018

Lecturer: Dr. Shayne Gad
 
29/01/2020
2 ימי לימודים מלאים
Non-Clinical Drug Safety Evaluation in Drug and Biologic Development
Lecturer: Dr. Shayne Gad
 

יפורסם בהמשך

יפורסם בהמשך
יום לימודים מלא
FIM - First In Man - Early Stage Clinical Studies for Drugs and Devices
Lecturer: Dr. Shayne C. Gad
  A Comprehensive overview of the design, conduct and reporting of First In Man (FIM) / Phase I Studies for the US and EU.
יפורסם בהמשך
3 ימי לימודים מלאים
Drug Safety Evaluation during Drug Development and Non-Clinical Studies
Lecturer: Dr. Shayne Gad
 
יפורסם בהמשך
יום לימודים מלא
Preparing Protocols & Final Reports for Clinical Trial
Lecturer: Dr. Shayne Gad
 
יפורסם בהמשך
3 ימי לימודים מלאים
Safety Assessment for Medical Devices and Combination Products
Lecturer: Dr. Shayne Gad
 
יפורסם בהמשך
2 ימי לימודים מלאים
Qualification of impurities, leachables, extractables; Residual solvents and excipients
Lecturer: Dr. Shayne Gad
 
יפורסם בהמשך
4 מפגשים, יום שלם
Protein Therapeutic Drugs - Analysis and Characterization
Lecturer: Mr. David Carr, USA
  This is a focused course of instruction on the instrumental analysis and characterization of polypeptides. The course emphasizes three important instrumental analytical technologies as they relate to the analysis and characterization of protein therapeutics
יפורסם בהמשך
יום לימודים מלא
eSource
Driving data capture efficiency

Lecturer: Ms. Tanya du Plessis
 
יפורסם בהמשך
2 ימי לימודים מלאים
Filters and Filtration in Aseptic Processes

Lecturer: Mr. Mark Trotter, USA
 
יפורסם בהמשך
יום לימודים מלא
Virus Clearance
Lecturer: Mr. Mark Trotter, USA
 
יפורסם בהמשך
יום לימודים מלא
Medical Devices
Implementation of the New Requirements of Health Canada

Lecturers: Dr. Valentin Fulga, Ms. Netta Fulga
 
יפורסם בהמשך
2 ימי לימודים מלאים
LC-MS of peptide and protein
biopharmaceuticals, characterization and quantitative analysis

Lecturer: Dr. Wilfried Niessen
 

ארועים שהסתיימו

2019

12/11/2019
2 ימי לימודים מלאים
From MDD to EU MDR
Lecturers: Mr. Robert Van Boxtel
 
05/11/2019
יום לימודים מלא
Beyond FDA
Lecturer: Ms. Shoshana (Shosh) Friedman, RAC, FRAPS
 
04/11/2019
יום לימודים מלא
Getting FDA Clearance/Approval for Medical DevicesWhat, When and How?
Lecturer: Ms. Shoshana Friedman
 
02/07/2019
2 ימי לימודים מלאים
Retrieving compound identity by LC-MS-MS technology
Lecturer: Dr. Wilfried Niessen
 
02/07/2019
יום לימודים מלא
Serialization

Lecturer: Mr. Allan Bowyer
 

2018

12/12/2018
יום לימודים מלא
Change as an Opportunity
Better Manage Projects in Clinical Trials

Lecturer: Mr. Stephen Carver
 
29/11/2018
יום לימודים מלא
FDA REMS
Risk Evaluation and Mitigation Strategies Program

Lecturer: Ms. Penelope Przekop
 
27/11/2018
יום לימודים מלא
EU GDPR
How it Impacts Pharmaceutical Companies and How to Ensure Compliance

Lecturer: Ms. Penelope Przekop
 
26/11/2018
יום לימודים מלא
ICH GCP E6 (R2)

Lecturer: Ms. Penelope Przekop
 
31/10/2018
יום לימודים מלא
Risk Management Workshop
Lecturer: Ms. Bosmat Friedman, Ms. Shoshana Friedman
 
24/10/2018
2 ימי לימודים מלאים
Regulatory Affairs of Medical Devices
Lecturer: Ms. Shoshana Friedman
 
29/05/2018
2 ימי לימודים מלאים
From MDD to EU MDR
Lecturers: Mr. Robert Van Boxtel
 
15/03/2018
יום לימודים מלא
The Pre-Submission Program
and Meetings with FDA Staff

Lecturer: Ms. Shoshana (Shosh) Friedman, RAC, FRAPS
 
14/03/2018
יום לימודים מלא
Clinical Trials with Medical Device
From Design to Final Report

Lecturer: Ms. Shoshana (Shosh) Friedman, RAC, FRAPS
 
14/03/2018
2 ימי לימודים מלאים
Biosimilars Seminar/Workshop
Status of the New Biosimilar Product

Lecturers: Dr. Hoss Dowlat
 
05/02/2018
2 ימי לימודים מלאים
Rheology and Viscosity Testing of Liquids and Semisolids
Lecturer: Mr. Neil Cunningham, UK
 
03/01/2018
2 ימי לימודים מלאים
RCA - Root Cause Analysis
Lecturer: Dr Malcolm Ross
 

2017

27/11/2017
יום לימודים מלא
Regulatory Strategy for Quality Management System under ISO 13485:2016 and FDA-QSR (21 CFR 820)


Lecturer: Ms. Shoshana Friedman
 
20/11/2017
2 ימי לימודים מלאים
Regulatory Affairs of Medical Devices
Lecturer: Ms. Shoshana Friedman
 
16/10/2017
2 ימי לימודים מלאים
Dissolution Testing
Lecturer: Dr. Malcolm Ross, Switzerland
 
06/09/2017
2 ימי לימודים מלאים
LC-MS of peptide and protein biopharmaceuticals, characterization and quantitative analysis
Lecturer: Dr. Wilfried Niessen
 
04/09/2017
2 ימי לימודים מלאים
Retrieving Compound Identity Using LC-MS-MS
Lecturer: Dr. Wilfried Niessen
 
15/03/2017
יום לימודים מלא
FDA Update: New Requirements, Trends and Guides
Lecturer: Ms. Shoshana Friedman
 
06/03/2017
יום לימודים מלא
Getting FDA Clearance/Approval for Medical Devices
What, When and How?

Lecturer: Ms. Shoshana Friedman
 
23/01/2017
יום לימודים מלא
International Workshop on Validation of Test Methods, Human Errors and Measurement Uncertainty of Results
Professional management: Dr. Ilya Kuselman
 

2016

13/12/2016
2 ימי לימודים מלאים
ISO 13485:2016 and EU MDR
Lecturers: Mr. Robert van Boxtel, Ms. Veronick Jasner
 
25/09/2016
2 ימי לימודים מלאים
Liquid Pharmaceuticals Scale up
Lecturer: Mr. Igor Gorsky
 
21/09/2016
2 ימי לימודים מלאים
Process Validation – Lifecycle Approach
Lecturer: Mr. Igor Gorsky
 
30/03/2016
2 ימי לימודים מלאים
Technology Transfer
Lecturer: Dr. Malcolm Ross, Switzerland
 
27/03/2016
2 ימי לימודים מלאים
RCA - Root Cause Analysis
Lecturer: Dr Malcolm Ross
 

2015

08/03/2015
2 ימי לימודים מלאים
Introduction to Quantitative Analysis of Peptides and Proteins by LC–MS Technologies
Lecturer: Dr. Wilfried Niessen
 
25/02/2015
2 ימי לימודים מלאים
Key Microbiology Audits
Lecturer: Mrs. Ziva Abraham
 
22/02/2015
2 ימי לימודים מלאים
Microbial Contamination Investigations
Lecturer: Mrs. Ziva Abraham
 
13/01/2015
יום לימודים מלא
International Workshop on Human Errors and Quality of Chemical Analytical Results
Professional management: Dr. Ilya Kuselman
 

2014

25/11/2014
חצי יום לימודים
Signal Detection and Signal Management
Lecturer: Dr. Irene Fermont, France
 
24/06/2014
2 ימי לימודים מלאים
EU Good Pharmacovigilance Practices : the guidelines for all your key processes
Lecturer: Dr. Irene Fermont, France
 
09/04/2014
2 ימי לימודים מלאים
Formulation for Chemists
Lecturer: Dr. Malcolm Ross, Switzerland
 
25/02/2014
2 ימי לימודים מלאים
Viscosity of Liquids and Semi-Solids
Lecturer: Mr Neil Cunningham, UK
 

2013

17/07/2013
2 ימי לימודים מלאים
Roles, Responsibilities & Activities of the QP in Europe and in Israel
Lecturers: Dr. Christopher Burgess, Mr. Richard Bonner
 
24/06/2013
יום לימודים מלא
Disinfectant Qualification & Cleaning Procedures
Lecturer: Mrs. Ziva Abraham
 
23/06/2013
יום לימודים מלא
Fungal Identification
Lecturer: Mrs. Ziva Abraham
 
28/05/2013
יום לימודים מלא
Preparing For and Passing an FDA Inspection
Lecturer: Mr. Michael Anisfeld, USA
 
27/05/2013
יום לימודים מלא
Effective Quality Risk Management & CAPA
Lecturer: Mr. Michael Anisfeld, USA
  A GMP Inspector’s Perspective on Compliance
29/01/2013
יום לימודים מלא
Workshop on Human Errors And Out-of-Specification Test Result
Professional management: Dr. Ilya Kuselman
 

2012

07/11/2012
יום לימודים מלא
The FDA 505 (b) (2) Drug Approval Process
Lecturer: Ken Phelps, President and CEO, Camargo Pharmaceutical Services, USA
  Reduce cost and timelines by using Strategy, Commercial and Regulatory aspects
30/10/2012
יום לימודים מלא
Advanced Immunogenicity
Lecturer: Dr. Ana Menendez, USA
 
28/10/2012
2 ימי לימודים מלאים
GMP Potency Bioassays and GLP Bioanalytics
Lecturer: Dr. Ana Menendez, USA
 
28/10/2012
יום לימודים מלא
Effective Quality Assurance Auditing
Lecturer: Mr. Michael Anisfeld, USA
  Make sure audits are worth the time and effort, and achieve their desired effect
24/10/2012
2 ימי לימודים מלאים
Fundamentals and Essentials of Validation
Lecturer: Mr. Michael Anisfeld, USA
 
22/07/2012
2 ימי לימודים מלאים
Analytical Data at the Service of the Regulatory, Formulation and QA Staff
Lecturer: Dr. Malcolm Ross, Switzerland
 
11/07/2012
2 ימי לימודים מלאים
Quantitative Analysis by LC–MS
Lecturer: Dr. Wilfried Niessen
  One of the most important applications of LC–MS is its use in routine quantitative analysis, in preclinical and clinical studies to sustain drug development, and in food safety and environmental analysis. This two-day course pays specific attention to aspects related to quantitative analysis by LC–MS for pharmaceutical applications as well as quantitative (multi)residue analysis by LC–MS for environmental and food-safety applications.
14/05/2012
יום לימודים מלא
Modern Thin Layer Chromatography
Lecturer:
 
30/04/2012
2 ימי לימודים מלאים
Rapid Microbiological Methods - RMM
Lecturer: Dr. Michael Miller, USA
 
10/01/2012
יום לימודים מלא
Analytical Methods in Biotechnology

Lecturer: Prof. Ira Krull
  Separation Techniques & Instrumentation Involved in the Biotech Industry

2011

01/06/2011
2 ימי לימודים מלאים
Marketing Authorization of Biologicals in the EU
Lecturer: Dr. Barbara Jentges
  This course focuses on the legislative environment regulating biologicals within the European Union and gives an understanding of the regulatory steps that need to be taken to successfully place a biological on the European market.
13/04/2011
יום לימודים מלא
The European Variations Rules & the Science Behind
Lecturer: Dr. Malcolm Ross, Switzerland
  This one day course is designed to address those changes which are related to product and production rather than the administrative changes that are related to labeling or change of address etc. This discusses variations from both the regulatory and the technical side and is designed to provide a deeper understanding of the technical process involved for regulatory and registration officers.
04/04/2011
2 ימי לימודים מלאים
Sterilization by Radiation
Lecturer: Mr. Martell Winters
 
07/03/2011
3 מפגשים, יום שלם
Analysis and Characterization of Protein Therapeutic Drugs
Lecturer: Mr. David Carr, USA
  This is a focused course of instruction on the instrumental analysis and characterization of polypeptides. The course emphasizes three important instrumental analytical technologies as they relate to the analysis and characterization of protein therapeutics
06/03/2011
2 ימי לימודים מלאים
Building eCTD-compliant Documents and Preparing an eCTD Submission
Lecturer: Dr. Barbara Jentges
  This course will give an understanding for ‘eCTD’ and the differing regional requirements. Aspects for the preparation of ‘eCTD-compliant’ documents will be discussed in detail during practical examples.
02/03/2011
חצי יום לימודים
Fundamentals to Design Strategic Immunogenicity Programs
Lecturer: Dr. Ana Menendez, USA
 
28/02/2011
2 ימי לימודים מלאים
Development & Validation of Biological Assay
Lecturer: Dr. Ana Menendez, USA
  The lecture portion of this course will outline sensible approaches to develop reproducible bioassays using live systems and/or biologically derived reagents. These approaches will be supplemented by guidelines to meet regulatory requirements according to their application. In addition, a workshop on writing validation protocols will provide hands-on experience to cover this pivotal document. During the course students will also hear caser studies that will add relevance to the lecture materials and provide a launch point for class discussion.
10/02/2011
יום לימודים מלא
Chiral Recognition and Separation Mechanisms
Lecturer: Prof. Nelu Grinberg, USA
  The course will focus on specific interactions between the enantiomeric analytes and each specific chiral stationary phase, rather than the techniques used to separate enantiomers. This approach will allow the participants to understand the strategies for development of a separation of enantiomers, along with the conditions to achieve each type of interaction.
09/02/2011
יום לימודים מלא
Biophamaceutics for Chemists - Concepts and Applications
Lecturer: Dr. Dionigio Franchi, Italy
 
26/01/2011
2 ימי לימודים מלאים
MedDRA® : A Comprehensive Training Course
Lecturer: Dr. Elliot Brown, UK
 

2010

27/12/2010
2 ימי לימודים מלאים
Optimizing the Drug Development Process using PK/PD Modeling
Lecturer: Dr. Serge Guzy, USA
 
29/11/2010
יום לימודים מלא
How to Evaluate Clinical Studies
and how to turn it into practical tools

Lecturers: Dr. Jack Spira
 
16/11/2010
3 ימי לימודים מלאים
Stabilization of Proteins and Peptides along the Formulation Process
Lecturer: Dr. Mark Cornell Manning, USA
 
21/07/2010
2 ימי לימודים מלאים
European Drug Regulatory Affairs: Strategy and Practice with European Regulatory Procedures
Lecturer: Dr. David Jacobs, Switzerland
 
16/06/2010
2 ימי לימודים מלאים
Development of Combination Products - Regulatory & Clinical Considerations
Lecturer: Dr. Barbara Fant
 
15/03/2010
2 ימי לימודים מלאים
Chemometric Techniques for Quantitative Analysis
Lecturer:
 
21/02/2010
מפגש, חצי יום
Medical Device Companies
Lecturer: Mr. Clay Anselmo
  This course will give an overview on worldwide regulatory frameworks, discussing how to develop Regulatory and QMS strategies to meet the business needs.
15/02/2010
2 ימי לימודים מלאים
Pharmacovigilance - basic level
Lecturer: Dr. Irene Fermont
 
21/01/2010
יום לימודים מלא
CITAC Workshop
Lecturers: Dr.I.Kuselman, Dr. W.Koch, Prof.H.Emons, Prof.I.Leito, Prof. P.De Bievre, Dr. J.Messman
  The course will cover metrological principles and practice in analytical laboratories important for quality assurance of analytical results, required by GLP & GMP standards, ISO/IEC 17025 standard, spread for competence of testing laboratories, other international documents and regulations. Use of reference materials as measurement standards, calculation of measurement uncertainty of analytical results, traceability of a routine result to national and international measurement standards and System International of Units (SI), interlaboratory comparisons and proficiency testing are the topics of the course.
19/01/2010
יום לימודים מלא
GMP עיקור בסביבת
Professional management: Ms. Yehudith Wexler
  Isranalytica 2010 – Related Events
17/01/2010
חצי יום לימודים
Gel Permeation Chromatrography (GPC) Systems in Pharmaceutical Applications
Lecturer: Dr. Mark Pothecary, UK
 

2009

15/12/2009
יום לימודים מלא
The New Euro Directive for Medical Devices
Lecturer: Dr. Christian Jarling
  This seminar gives instructions how to assemble a Technical File in compliance with the European Directives on Medical Devices. This file shall not only comply with the regulatory requirements, but also give an understanding, what a reviewer / auditor expects from a Technical File.
02/12/2009
2 ימי לימודים מלאים
Film Coating
Lecturer: Dr. Stuart Porter, USA
  This course is intended for scientists responsible for the development of film-coated oral solid dosage forms, and scientist, engineers, operators and supervisors responsible for providing technical support with respect to film-coated products.
15/07/2009
חצי יום לימודים
How Current Are You? Review of New Industry and Regulatory Expectations For Biopharmaceutical Products
Lecturer: Dr. Ana Menendez, USA
  2008 was a banner year for generating important industry white papers and regulatory guidelines for biopharmaceutical products. This meeting specifically addresses updates that should be implemented in post-2009 development and validation programs both in the GMP and the GLP arena.
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.
18/05/2009
2 ימי לימודים מלאים
Patient Recruitment Strategy: A Comprehensive Workshop for Investigative Sites and Sponsors
Lecturer: Mr. John Needham (USA)
  The course focuses on the skills of the people who are responsible for recruitment success including their personal development (Me), their relationship with their immediate supervisor or client (We) and the role of their efforts in the overall study and the public’s health (Us).
12/05/2009
יום לימודים מלא
Validation of Analytical Methods for Proteins
Lecturer: Prof. Ira Krull, USA
  The course will provide a description and summary of how to develop, optimize, and validate analytical methods for small and large biomolecules. The course will pursue commonly found protein variants and posttranslational modifications in biopharmaceutical products, and how these are commonly assayed for today. Current FDA requirements for protein biopharmaceutical products will also be explored and intensively discussed.
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.
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.

2008

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.
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.
04/11/2008
2 ימי לימודים מלאים
CMC Submissions in the CTD Format
Lecturer: Carolyn H. Kruse, USA
  This course will address the regional requirements and the differences in approaches to document review for the three ICH territories: US, EU and Japan. This course will provide an in depth review of the chemistry, manufacturing and controls (CMC) requirements for development and ultimate submission to the FDA and other Regulatory Authorities for the new drug applications (NDA’s).
07/09/2008
2 ימי לימודים מלאים
Pharmaceutical Product Risk
Lecturer: Dr Stanley Garbus (USA)
  The course is based on the risk (risk/benefit assessment) for prescription drug products but the concept of Risk Management and Mitigation is universal and being recognized by regulatory authorities as necessary for devices and biotech products as well.
03/09/2008
2 ימי לימודים מלאים
Clinical Project Management
Lecturer: Dr Stanley Garbus - USA
  The course begins by describing the basic fundamentals and pharmaceutical industry standards of project management techniques. Details are presented for understanding clinical trial costs and developing timely budgets to create successful study completion on budget. Participants learn skills of leadership, negotiation and communication that will positively impact the success of clinical projects.
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.

2007

30/11/2007
יום לימודים מלא
Bioassay Development and Validation
Lecturer: Dr. David Lansky, USA
  This two day course covers the fundamental concepts needed to understand bioassay, bioassay development, validation of bioassays, setting specifications for bioassays, and setting product specifications based on bioassay measurements.
30/11/2007
יום לימודים מלא
Design of Experiments for Efficient and Practical Assay Development and Validation
Lecturer: Dr. David Lansky, USA
  This 2-day course covers design of experiments (DOE) as used for development and validation of assays.
25/07/2007
2 ימי לימודים מלאים
Analytical Biotechnology
Lecturer: Prof. Ira Krull
  Separation Techniques & Instrumentation Involved in the Biotech Industry
12/07/2007
יום לימודים מלא
Technical Files
Lecturer: Dr. Christian Jarling, Germany
  This seminar provides instructions of how to write and/or assemble a Technical File in compliance with the European Directives on Medical Devices (MDD - 93/42/EEC), as well as understanding the reviewer / auditor point of view; what a reviewer / auditor expects from a Technical File?
11/07/2007
יום לימודים מלא
Risk Management
Lecturer: Dr. Christian Jarling, Germany
  This seminar will demonstrate the procedure of how to analyse, assess and manage risks inherent in a specific medical device and will discuss means of properly documenting the outcome. In addition, upcoming changes in the risk management standard will be included in the seminar.
07/06/2007
יום לימודים מלא
GTP - Good Tissue Practice
Lecturer: Ms. Eliane Schutte, the Netherlands
  At the end of the one day-seminar participants will have an in-depth knowledge of the FDA Current Good Tissue Practice and understand the key critical items.
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