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מנוי

Quality

Home :: All Courses Number of Courses: 202

Upcoming

2018

23/07/2018
1 - Day Course
Data Integrity
Data governance and Quality Metrics

Lecturer: Ms. Karen Ginsbury
 
03/09/2018
1 - Day Course
Risk assessment
Lecturer: Dr. Sigalit Arieli-Portnoy
 
03/09/2018
1 - Day Course
הדרכה במאה ה-21הזדמנויות אתגרים ודרישות
Lecturers: Tali Gan
 
17/10/2018
1 - Day Course
GAMP5 - יישום גישת ניהול סיכונים במערכות ממוחשבות
Lecturers: Ms. Daphna Spector-Grossbard
 
22/10/2018
2 - Day Course
Inspections and audits in Pharmacovigilance


Lecturers: Dr. Irene Fermont, MD, MSc, EUQPPV
 
22/10/2018
1 - Day Course
Supply Chain Risk Management – an Interactive Workshop
Professional management: Mr. David Inbar
 
29/10/2018
1 - Day Course
גידול צמחי קנאביס רפואי בתנאים נאותים
Lecturer: Mr. Eran Yona
 
04/11/2018
2 - Day Course
מבדקי אמ"ר
Lecturer: Ms. Iris Leinwand
 
15/11/2018
1 - Day Course
ניהול סיכונים עבור יבואנים ובתי מסחר
Lecturers: Ms. Yafit Toledano
 
26/11/2018
2 - Day Course
Filters and Filtration in Aseptic Processes

Lecturer: Mr. Mark Trotter, USA
 
26/11/2018
2 - Day Course
מערכת HVAC במפעלים פרמצבטיים וביוטכנולוגיים
Lecturer: Mr. Jose (Yossi) Chvaicer, Dr. Sigalit Arieli-Portnoy
 
28/11/2018
1 - Day Course
Control of Suppliers and Sub Contractors
Lecturer: Mr. Gadi Shtepel
 
29/11/2018
1 - Day Course
Virus Clearance
Lecturer: Mr. Mark Trotter, USA
 
12/12/2018
1 - 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.
17/12/2018
1 - Day Course
יצור בתנאי GMP של קנאביס רפואי
Lecturers: Dr. Rachel Karpel
 
20/12/2018
1 - Day Course
גישות בניהול טכנולוגיות תפעול (OT) במפעל הביורפואי
Lecturer: Mr. Eran Yona, משה רדוביץ
 
27/12/2018
1 - Day Course
אמ"ר משולב ענן IoMT
Lecturer: Mr. Guy Vinograd
 

2019

09/01/2019
1 - Day Course
Impurities in APIs and Pharmaceutical Products
Current Regulatory Requirements

Lecturer: Dr. Rachel Karpel
 

TBA

TBA
1 - Day Course
Strategies and Resources for Effective GMP Training
Lecturer: Ms. Karen Ginsbury
  This one day seminar will provide a novel approach to training strategies moving away from the classic “read and understand” and frontal approaches. Tools will be presented for risk communication and to engage personnel at all levels of the company in understanding why they have to do what they have to do.
TBA
2 - Day Course
Creating and Managing an Intranet Portal as a Knowledge Mangement Tool
Lecturer: Dr. Nava Rotem
 
TBA
2 - Day Course
Risk Management in Aseptic Processing
Lecturer: Ms. Karen Ginsbury
 
TBA
1 - Day Course
Internal Audits and Management Review
Lecturer: Mr. Gadi Shtepel
 
TBA
2 - Day Course
דיגום בתעשייה - היבטים סטטיסטיים
Lecturer: Dr. Evgeny Tartakovsky
 
TBA
1 - Day Course
Quality Agreement
Lecturers: Ms. Karen Ginsbury, Dr. Rachel Karpel
 
TBA
4 Half day (evening courses)
Uncertainty in Calibration and Measurements
Lecturer: Mr. Teddy Hoffman
 
TBA
2 - Day Course
From collection to reporting processing your safety cases in clinical trials and post marketing
Lecturers: Dr. Irene Fermont, MD, MSc, EUQPPV
 
TBA
2 - Day Course
Outsourced Operations: Managing Contractors
(including Quality Agreements)

Lecturer: Ms. Karen Ginsbury
 
TBA
2 - Day Course
GLP
Lecturer: Dr. Oded Laor
 
TBA
1 - Day Course
דה-פירוגנציה ושיטות לסילוק אנדוטוקסינים
Lecturer: Mr. Amit Sheinfeld
 
TBA
1 - Day Course
CAPA בסביבת GCP
Lecturers: Dr. Liat Ben-David
 
TBA
1 - Day Course
Medical Devices Regulation in Canada
Principles and Recent Updates

Lecturers: Dr. Valentin Fulga, Ms. Netta Fulga
 
TBA
1 - Day Course
הבטחת איכות משאבי אנוש
Lecturers: Ms. Yafit Toledano
 
TBA
1 - Day Course
בקרת תהליכים סטטיסטית – SPC למפעילים

Lecturer: Dr. Benny Yoskovich
 
TBA
1 - Day Course
בדיקות אנדוטוקסין בשיטות LAL
Lecturer: Mr. Amit Sheinfeld
 

Past Activities

2018

11/07/2018
1 - Day Course
Environmental Monitoring
Lecturer: Ms. Karen Ginsbury
 
14/06/2018
2 - Day Course
Planning and performing internal auditsaccording to the GMP
Lecturer: Dr. Orna Dreazen
 
10/06/2018
1 - Day Course
Design Control
Lecturer: Ms. Veronick Gesner
 
29/05/2018
2 - Day Course
From MDD to EU MDR
Lecturers: Mr. Robert Van Boxtel
 
16/05/2018
3 - Day Course
CIP – Cleaning In Place Technology
Lecturer: Mr. Moshe Landsberg
 
09/05/2018
1 - Day Course
GMP/GDP Updates
Lecturer: Ms. Karen Ginsbury
 
30/04/2018
1 - Day Course
דרישות GMP מיבואנים של תכשירים רפואיים
Lecturers: Dr. Rachel Karpel
 
26/04/2018
2 - Day Course
Auditing of Clinical Trials
Lecturers: Dr. Liat Ben-David
 
14/03/2018
2 - Day Course
Biosimilars Seminar/Workshop
Status of the New Biosimilar Product

Lecturers: Dr. Hoss Dowlat
 
12/02/2018
1 - Day Course
איכות בניהול יצרנים לפי חוזה - CMO's
Lecturers: Dr. Gil Zomber
 
06/02/2018
4 - Day Course
Advanced HPLC
Lecturer: Mr. Igal Gozlan
 
06/02/2018
1 - Day Course
Documentation Control, Change Control & Configuration Management
Lecturer: Mr. Gadi Shtepel
 
01/02/2018
1 - Day Course
עריכת מבדקי ספקים
Lecturers: Ms. Yafit Toledano
 
18/01/2018
1 - Day Course
ניתוח, הערכה וניהול סיכונים של תרופות
Lecturer: Mr. Eran Yona
 
15/01/2018
1 - Day Course
Managing Calibration Systems as Part of the QA System
Lecturers: Dr. Alex Lapak, Dr. Orna Dreazen
 
10/01/2018
2 Meetings
Quality Assurance of Computerized Systems- A Comprehensive Perception
Lecturer: Ms. Daphna Spector-Grossbard
 
03/01/2018
2 - Day Course
RCA - Root Cause Analysis
Lecturer: Dr Malcolm Ross
 

2017

18/09/2017
1 - Day Course
Customer Complaints, Vigilance Reporting and Post Market Surveillance
Lecturer: Mr. Gadi Shtepel
 
06/09/2017
1 - Day Course
ICH, EMEA and FDA Guidelines for Drug and Drug-Substances Stability
Lecturer: Dr. Rachel Karpel
 
05/09/2017
1 - Day Course
Risk assessment
Lecturer: Dr. Sigalit Arieli-Portnoy
 
03/09/2017
1 - Day Course
הדרכה במאה ה-21הזדמנויות אתגרים ודרישות
Lecturers: Tali Gan
 
09/07/2017
2 - Day Course
Risk Management Plan
are you in compliance with the new Israeli regulation?

Lecturers: Dr. Irene Fermont, MD, MSc, EUQPPV
 
29/06/2017
1 - Day Course
Supply Chain Risk Management – an Interactive Workshop
Professional management: Mr. David Inbar
 
06/06/2017
1 - Day Course
Conducting Effective Internal Pharmaceutical Compliance Audits
Lecturer: Ms. Karen Ginsbury
 
17/05/2017
1 - Day Course
ProMedoss Event 2017
:
 
27/04/2017
1 - Day Course
בדיקות אנדוטוקסין בשיטות LAL
Lecturer: Mr. Amit Sheinfeld
 
26/04/2017
1 - Day Course
נוהל 129
Lecturers: Ms. Yafit Toledano
 
04/04/2017
1 - Day Course
Batch Release
Lecturer: Dr. Rachel Karpel
 
28/03/2017
1 - Day Course
יצור בתנאי GMP של קנאביס רפואי
Lecturers: Dr. Rachel Karpel
 
15/03/2017
3 - Day Course
CIP – Cleaning In Place Technology
Lecturer: Mr. Moshe Landsberg
 
21/02/2017
1 - Day Course
Design Control
Lecturer: Ms. Veronick Gesner
 

2016

13/12/2016
1 - Day Course
Integrating Compliance into Facility Projects in Pharmaceutical Industries
Lecturer: Mr. Effi Amir, Mr Lewis Josman
 
13/12/2016
2 - Day Course
ISO 13485:2016 and EU MDR
Lecturers: Mr. Robert van Boxtel, Ms. Veronick Jasner
 
04/12/2016
1 - Day Course
Deviations, Investigations, CAPA
and ISO9001:2015

Lecturer: Ms. Karen Ginsbury
 
08/11/2016
1 - Day Course
Handling Out of Specification (OOS), Out of Trend (OOT) and Unexpected Results
Lecturer: Ms. Karen Ginsbury
 
07/11/2016
1 - Day Course
הגורם האנושי בניתוח אירועי איכות ובטיחות
Lecturer: Mr. Menachem Horev
 
07/11/2016
1 - Day Course
דרישות GMP מיבואנים של תכשירים רפואיים
Lecturers: Dr. Rachel Karpel
 
01/11/2016
7 Half day (evening courses)
GCP - Good Clinical Practice
Professional management: Ms. Yehudith Wexler
 
20/09/2016
2 - Day Course
Software Validation - Practical Aspects
Lecturer: Mr. Mike Zeevi
 
13/09/2016
2 - Day Course
Planning and performing internal audits
according to the GMP

Lecturer: Dr. Orna Dreazen
 
05/09/2016
1 - Day Course
Implementation of Worst Case Approach In Cleaning Validation Systems
Lecturer: Mr. Effi Amir
 
13/07/2016
1 - Day Course
Data Integrity and Data Governance
are you managing this in your company?

Lecturer: Ms. Karen Ginsbury
 
20/06/2016
1 - Day Course
Quality Metrics A tool for managing quality
and getting the attention of senior management

Lecturer: Ms. Karen Ginsbury
 
08/06/2016
2 - Day Course
GLP
Lecturer: Dr. Oded Laor
 
06/06/2016
1 - Day Course
Non Conforming Product and CAPA systems
Lecturer: Mr. Gadi Shtepel
 
16/05/2016
2 - Day Course
מערכת HVAC במפעלים פרמצבטיים וביוטכנולוגיים
Lecturer: Dr. Sigalit Arieli-Portnoy, Mr. Joseph Schweitzer
 
03/05/2016
1 - Day Course
EU Technical File
How to Prepare and Submit

Lecturer: Dr. Raanan Aloni
 
13/04/2016
1 - Day Course
Inspection Readiness
Are you ready for a regulatory inspection / customer audit?

Lecturer: Ms. Karen Ginsbury
 
30/03/2016
2 - Day Course
Technology Transfer
Lecturer: Dr. Malcolm Ross, Switzerland
 
27/03/2016
2 - Day Course
RCA - Root Cause Analysis
Lecturer: Dr Malcolm Ross
 
01/03/2016
1 - Day Course
Managing Calibration Systems as Part of the QA System
Lecturers: Mr. Sasha Nezlin, Mr. Teddy Hoffman
 
03/02/2016
1 - Day Course
GAMP5 - יישום גישת ניהול סיכונים במערכות ממוחשבות
Lecturers: Ms. Daphna Spector-Grossbard
 
01/02/2016
1 - Day Course
Effective Management Of Manufacturing Process Investigations - Workshop

Lecturer: Dr. Tanya Gershnik
 

2015

02/12/2015
1 - Day Course
Packaging Controls and GMP for Printed Packaging Materials
Lecturer: Ms. Karen Ginsbury
 
24/11/2015
1 - Day Course
Good Weighing Procedures
Lecturer: Mr. Gidi Wilenski, Mr. Shai Lavi
 
06/07/2015
1 - Day Course
Cleaning Validation
Lecturer: Ms. Karen Ginsbury
 
15/06/2015
2 - Day Course
Setting up, Implementation and Continuous Improvement of the Pharmaceutical Quality System
Lecturer: Ms. Karen Ginsbury
 
07/06/2015
3 - Day Course
Auditing of Clinical Trials
Lecturers: Ms. Ayelet Lebanon, Mr. Danny Korner, Mrs. Liat Ben-David, Ms. Moran Ploznik
 
07/06/2015
3 - Day Course
GMP בחדרים נקיים וסביבת עבודה מבוקרת – קורס מעשי
Lecturers: Dr. Moti Yizhar
 
23/03/2015
1 - Day Course
Compliance with Medical Device Standards and Regulations
Lecturer: Dr. Judah Lando
 
22/02/2015
2 - Day Course
Microbial Contamination Investigations
Lecturer: Mrs. Ziva Abraham
 
19/01/2015
1 - Day Course
GxP Updates – FDA, PIC/s and ICH
Lecturer: Ms. Karen Ginsbury
 

2014

30/12/2014
1 - Day Course
Managing Calibration Systems as Part of the QA System
Lecturers: Mr. Sasha Nezlin, Mr. Teddy Hoffman
 
15/12/2014
1 - Day Course
Use of Risk Assessment in Managing Change

Lecturer: Ms. Karen Ginsbury
 
12/11/2014
3 - Day Course
Develop Your Skills as an Effective Auditor for the Medical Device Industry
Lecturer: Mrs. Yana Prus-Galynsky
 
09/07/2014
1 - Day Course
Conducting Effective Investigations
Lecturers: Ms. Karen Ginsbury, Dr. Rachel Karpel
 
30/06/2014
1 - Day Course
US FDA Quality System Requirements (21 CFR Part 820)
Lecturer: Dr. Judah Lando
 
20/01/2014
2 - Day Course
Conducting Effective Pharmaceutical Compliance Audits
Lecturers: Ms. Karen Ginsbury, Dr. Rachel Karpel
 
13/01/2014
2 - Day Course
PAT, NIR and QBD
Lecturer: Dr. Howard Mark
  Advanced Course

2013

25/11/2013
1 - 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
20/11/2013
2 - Day Course
איכות במעבדות QC
Lecturer: Dr. Ofer Dubinsky
 
28/10/2013
1 - Day Course
Good Engineering and Maintenance Practices a Critical Element of the Quality System
Lecturer: Ms. Karen Ginsbury
 
16/10/2013
1 - Day Course
System & Equipment Qualification & Validation
Lecturer: Ms. Karen Ginsbury
  Including case-studies, handling deviations (+ a sneak peep at the FDA Process Validation Draft)
08/08/2013
1 - Day Course
R&D in a GMP Environment
Lecturer: Ms. Karen Ginsbury
 
28/07/2013
1 - Day Course
ICH Quality Guidelines Q1- Q6
Lecturers: Ms. Karen Ginsbury
  Product Development and Life Cycle
17/07/2013
2 - Day Course
Roles, Responsibilities & Activities of the QP in Europe and in Israel
Lecturers: Dr. Christopher Burgess, Mr. Richard Bonner
 
03/07/2013
1 - Day Course
Documentation Control
Lecturer: Ms. Karen Ginsbury
 
24/06/2013
1 - Day Course
Disinfectant Qualification & Cleaning Procedures
Lecturer: Mrs. Ziva Abraham
 
24/06/2013
1/2 - Day Course
עדכוני GDP - GOOD DISTRIBUTION PRACTICE
Lecturers: Ms. Karen Ginsbury, Dr. Rachel Karpel
 
23/06/2013
1 - Day Course
Fungal Identification
Lecturer: Mrs. Ziva Abraham
 
05/06/2013
2 - Day Course
Thermal Validation and Monitoring in GMP Environment
Lecturer: Mr. Johan Stormlund, Germany
 
04/06/2013
1 - Day Course
Managing Calibration Systems as Part of the QA System
Lecturers: Dr. Orna Dreazen, Mr. Teddy Hoffman
 
28/05/2013
1 - Day Course
Preparing For and Passing an FDA Inspection
Lecturer: Mr. Michael Anisfeld, USA
 
27/05/2013
1 - Day Course
Effective Quality Risk Management & CAPA
Lecturer: Mr. Michael Anisfeld, USA
  A GMP Inspector’s Perspective on Compliance
18/03/2013
1 - Day Course
Analytical Instrument Qualification
Lecturer: Ms. Karen Ginsbury
 
07/03/2013
1 - Day Course
דרישות GMP מיבואנים של תכשירים רפואיים
Lecturers: Dr. Rachel Karpel
 

2012

13/11/2012
1 - Day Course
ICH Q11 Guidance on: Development and Manufacture of Drug Substances
Lecturers: Ms. Karen Ginsbury
  ICH Q11 Guidance on: Development and Manufacture of Drug Substances
07/11/2012
1 - Day Course
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
29/10/2012
2 - Day Course
HVAC Systems
Lecturers: Ms. Karen Ginsbury
  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.
28/10/2012
1 - Day Course
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 - Day Course
Fundamentals and Essentials of Validation
Lecturer: Mr. Michael Anisfeld, USA
 
07/08/2012
1 - Day Course
דה-פירוגנציה ושיטות לסילוק אנדוטוקסינים
Lecturer: Mr. Amit Sheinfeld
 
06/08/2012
1 - Day Course
Usability Engineering
Lecturer: Mr. Nissim Oz
 
22/07/2012
2 - Day Course
Analytical Data at the Service of the Regulatory, Formulation and QA Staff
Lecturer: Dr. Malcolm Ross, Switzerland
 
17/05/2012
1 - Day Course
Phase Appropriate GMP for Investigational Products
Lecturer: Ms. Karen Ginsbury
 
15/05/2012
1 - Day Course
דרישות GMP מיבואנים של תכשירים רפואיים
Lecturers: Dr. Rachel Karpel
 
30/04/2012
2 - Day Course
Rapid Microbiological Methods - RMM
Lecturer: Dr. Michael Miller, USA
 
18/04/2012
1 - Day Course
GAMP5 - יישום גישת ניהול סיכונים במערכות ממוחשבות
Lecturers: Ms. Daphna Spector-Grossbard
 
25/01/2012
1 - Day Course
משאבי אנוש, הדרכה, הנהלה - ומה שביניהם
Lecturer: Dr. Hagit Yariv
 

2011

12/12/2011
1 - Day Course
Managing Calibration Systems as Part of the QA System
Lecturers: Dr. Orna Dreazen, Mr. Teddy Hoffman
 
30/11/2011
1 - Day Course
EU GMP Update
Lecturer: Ms. Karen Ginsbury
 
09/10/2011
2 Meetings
Effective Quality Management and the ICH Quality Guidelines

Lecturer: Ms. Karen Ginsbury
  The 9 finalized Q" guidlines and the Q10, almost final "Q" guidline – what are they about?
12/09/2011
1 - Day Course
CRF Design Workshop
Lecturer: Ms. Tali Azulay
 
03/08/2011
2 - Day Course
Microbiological Best Laboratory Practices
Lecturer: Ms. Karen Ginsbury
 
27/07/2011
1 - Day Course
Regulatory Intelligence (RI)
Lecturer: Mr. Daniel Albahari
 
17/07/2011
2 - Day Course
Risk Assessment Workshops
Lecturer: Ms. Karen Ginsbury
  PRACTICAL INTERACTIVE EXERCISES TO LEARN HOW TO APPLY RISK ASSESSMENT TOOLS. For the first time ever in Israel – a Risk Assessment workshop tailored to the needs of the pharmaceutical industry. No more talking – this is a “Doing it” Seminar, so come prepared to work! Join Industry Expert Karen Ginsbury in performing FOUR Risk Assessment case studies during a stimulating, hands-on two day workshop.
05/07/2011
1 - Day Course
Enhancing QC Laboratory Efficiency, a Course for Managers
Lecturer: Dr. Sigalit Arieli-Portnoy
 
27/04/2011
2 - Day Course
Materials Management - Supply Chain
& GMP

Lecturers: Ms. Karen Ginsbury
 
10/02/2011
1 - Day Course
Purchasing and Logistics for Research and Manufacturing
Lecturer:
 
07/02/2011
1 - Day Course
Best Practices for Online Learning
:
 
25/01/2011
1 - Day Course
Israeli Legislation on the Quality of Drugs and Biologics
Lecturers: Dr. Rachel Karpel, Adv. Yoel Lifshitz
 

2010

20/12/2010
1 - Day Course
GAMP5 - יישום גישת ניהול סיכונים במערכות ממוחשבות
Lecturers: Ms. Daphna Spector-Grossbard
 
25/10/2010
3 - Day Course
GDP - תנאי הפצה נאותים
Professional management: Mgr. Efrat Strugo
 
18/07/2010
2 - Day Course
How to Build and Validate Excel Spreadsheets
Lecturer: Mr. David Nettleton
 
08/07/2010
1 - Day Course
Data Management & Statistical Methods in Clinical Trials
Lecturer: Ms. Tali Azulay
 
07/07/2010
1 - Day Course
Quality Assurance in the QC Laboratory
Lecturer: Ms. Karen Ginsbury
 
08/06/2010
1 - Day Course
Managing Calibration Systems as Part of the QA System
Lecturers: Dr. Orna Dreazen, Mr. Teddy Hoffman
 
21/02/2010
Meeting
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.
02/02/2010
3 - Day Course
Developing Clinical Quality Assurance Audit Skills and Procedures (CQA)
Lecturer: Mr. Steve Schwartz, USA
 
21/01/2010
1 - Day Course
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
1 - Day Course
GDP - בדרך לאבטחת איכות ובטיחות התרופה
Professional management: Ms. Karen Ginsbury
  מפגש במסגרת הכינוס ה-13 של החברה הישראלית לכימיה אנליטית
19/01/2010
1 - Day Course
GMP עיקור בסביבת
Professional management: Ms. Yehudith Wexler
  Isranalytica 2010 – Related Events

2009

10/09/2009
1 - Day Course
GMP Aspects of Analytical Quality Control including OOS results
Lecturer: Ms. Karen Ginsbury
  The Quality Control Laboratory is consistently featuring at the top of the deficiency lists in regulatory inspections. This is a chance to be up-dated and to minimize the chance of adverse inspectional outcome in your laboratory.
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
1 - 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
 
26/05/2009
1 - Day Course
Quality Product Review
Lecturer: Ms. Karen Ginsbury
  This one day course will take an in depth look at the regulatory requirements (EU and FDA) for performing quality reviews in the context of Q10 – Pharmaceutical Quality System Guidance which requires Management Review and ongoing product and process performance monitoring, as well in the light of the draft FDA guidance on Process Validation that requires ongoing process verification. Product Annual Review as performed by companies to-date will be a large part of the quality review but this course will review those additional elements that are required in order to remain current with updated regulations and expectations.
11/02/2009
1 - 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.

2008

16/12/2008
1 - 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
1 - Day Course
Managing Calibration Systems as Part of the QA System
Lecturers: Dr. Orna Dreazen, Mr. Teddy Hoffman
 
17/06/2008
1 - Day Course
דה-פירוגנציה
Lecturer:
 
04/06/2008
2 - Day Course
Q7A: GMP for APIs and Vendor Qualification
Lecturer: Ms. Karen Ginsbury
  The goal of this course is to review quality systems and GMP requirements as they relate to vendor qualification. This two day in-depth course will consider current regulatory and quality issues that may arise from inadequate control of starting materials and place vendor qualification in that context as well as incorporating the use of risk management principles in a vendor certification program.
29/04/2008
4 - Day Course
Quality in Registration Files
Lecturer: Dr. Rachel Karpel
 
25/02/2008
1 - Day Course
Product & Process Lifecycle 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 guidances. A draft annex to ICH Q8 has just been issued that provides additional clarification regarding its implementation. Inspectors world-wide are undergoing intensive training and discussions about how to perform Quality by Design (QbD) inspections. Will your company be ready to meet the challenge. These three closely integrated guides are global, consensus guides that are being implemented by EMEA, FDA and worldwide. The course will provide an understanding of the need for the guidances, will review the guidances using case studies to explain how they can be integrated into existing quality systems particularly with a view to QA in R&D.

2007

25/12/2007
1 - Day Course
The Microbiology of Environmental Monitoring (EM)
Lecturer: Ms. Karen Ginsbury
 
24/12/2007
1 - Day Course
הג'ודו כמנוף לרענון והטמעה של ה-GMP
Lecturer:
 
14/08/2007
1 - Day Course
ICH Quality Guidelines
Lecturer: Ms. Karen Ginsbury
 
02/07/2007
1 - Day Course
Compliance and Passing Inspections
Lecturer: Ms. Karen Ginsbury
  The goal of this course is to provide an understanding of how to be substantially in compliance with cGMP requirements and how to demonstrate to an inspector, during a regulatory audit, that you are in compliance with the requirements.
07/06/2007
1 - Day Course
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.
30/05/2007
1 - 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.
29/05/2007
1 - Day Course
Pharmaceutical Microbiology
Lecturer: Ms. Karen Ginsbury
  This one day course will take an in depth look at the regulatory requirements (EU and FDA) for microbiological control of pharmaceuticals. This topic is receiving greater scrutiny in regulatory inspections and becoming of ever-increasing importance to the regulators.
18/04/2007
2 - Day Course
From R&D to a Product – Implementation of Quality Aspects in the Registration File
Lecturer: Dr. Rachel Karpel
 
05/02/2007
1 - Day Course
GMP for Active Pharmaceutical Ingredients (APIs) - ICH Q7A
Lecturer: Karen Ginsbury
  The goal of the course is to review the GMP requirements applicable to manufacture and control of Active Pharmaceutical Ingredients (APIs). The course will look at the requirements from the perspective of the API manufacturers but also from the view of the finished dosage form manufacturer who is dependent on the manufacturer to provide an uninterrupted supply of material of the required quality that repeatedly and reliably meets the pre-agreed specifications as registered in the dosage form manufacturer's regulatory filing.

2006

30/11/2006
1 - Day Course
FDA Update Sep. 06: Implementing cGMP in Quality Systems
Lecturer: Karen Ginsbury
  The objective of this one day course is to provide a detailed review of the new guidance with hands on translation into day to day procedures for managing quality within your company in compliance with current expectations for quality systems.
13/11/2006
1 - Day Course
Equipment Validation
Lecturer: Ms. Karen Ginsbury
 
09/09/2006
2 - Day Course
GMP in Production of Phase I Clinical Trial Materials
Lecturer: Karen Ginsbury
 
01/08/2006
1 - Day Course
Production Controls
Lecturer: Karen Ginsbury
  This seminar will look at those aspects of production that may undergo intensive scrutiny during a regulatory audit.
05/06/2006
2 - Day Course
Component Controls
Lecturer: Karen Ginsbury
  The goal of this workshop is to review the requirements for vendor qualification in depth, including the ICH Q7A guideline that they need to work with. Understanding the importance of raw materials and primary packaging materials controls can significantly reduce the number of rejected batches and improve your regulatory compliance profile.
02/04/2006
2 - Day Course
Engineering / Maintenance of Facilities and Equipment
Lecturer: Karen Ginsbury
  Design controls, commissioning, validation / qualification, maintenance, cleaning, calibration and use.
09/03/2006
1 - Day Course
Compliance and Passing Inspections
Lecturer: Karen Ginsbury
 

2005

21/11/2005
1 - Day Course
GMP of Printed Packaging Materials
Lecturer: Karen Ginsbury
 
31/10/2005
2 - Day Course
Vendor Approval and Q7A
Lecturer: Karen Ginsbury
 
07/09/2005
2 - Day Course
The Microbiology of Environmental Monitoring (EM)
Lecturer: Karen Ginsbury
 
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