|
|
|
|
|
|
|
|
|
|
|
|
|
|
12/06/2013
4 - Day Course
|
Advanced HPLC
Lecturer: Mr. Igal Gozlan
|
| |
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
29/07/2013
2 - Day Course
|
PAT, NIR and QBD
Lecturer: Dr. Mark Howard, USA
|
| |
Advanced Course |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14/11/2013
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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13/03/2013
1 - Day Course
|
Change Management According to the Q10 Guidelines
Lecturer: Ms. Karen Ginsbury
|
| |
This one day, intensive course will address management of change in an industry that has been traditionally skeptical of the need or desire to improve systems that aren’t actually broken. |
|
|
|
|
|
06/03/2013
2 - Day Course
|
Planning and performing internal audits according to the GMP
Lecturer: Dr. Orna Dreazen
|
| |
Throughout the course, we shall be discussing the various components of planning an audit based on risk management, performing an audit and drawing conclusions from internal audits. We shall also discuss the evaluation of the effectiveness of the corrective measures implemented by the organization. |
|
|
|
|
|
|
|
|
|
07/01/2013
2 - Day Course
|
Uncertainty in calibration and measurements
Lecturer: Mr. Teddy Hoffman
|
| |
This course will clarify parameters in calibration and measurements. Participants will receive the tools necessary to evaluate the uncertainty and to start to calculate it. |
|
|
|
|
|
20/12/2012
1 - Day Course
|
GDP - Good Distribution Practice
Lecturers: Ms. Karen Ginsbury, Dr. Rachel Karpel
|
| |
Participants will come away from this course with an understanding of Good Distribution Practice, why and how need to be implemented, and how to measure, control and improve that implementation. |
|
|
|
|
|
TBA
2 - 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. |
|
|
|
|
|
20/11/2012
1 - Day Course
|
Batch Release
Lecturer: Dr. Rachel Karpel
|
| |
|
|
|
|
|
|
|
|
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, Mr. Uri Harel
|
| |
There is no pharmaceutical facility that is not equipped with a controlled HVAC system. Pharmaceutical facilities are provided with filtered air to ensure an environment that is controlled with respect to particle contamination: both viable and non-viable. This course will provide participants with an understanding of the design of such systems, GMP requirements behind the design, qualification and ongoing operation, maintenance and monitoring. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
24/07/2012
1 - Day Course
|
Risk Management for Medical Devices
Lecturer: Mr. Gadi Shtepel
|
| |
Mandatory requirements for Risk Management in the Design, Development and Manufacturing of Medical Devices are defined in ISO 13485:2003 and ISO 14971:2007 standards. The ISO 14971:2007 was also recognized by the FDA as a Consensus Standard for Risk Management. |
|
22/07/2012
2 - Day Course
|
Analytical Data at the Service of the Regulatory, Formulation and QA Staff
Lecturer: Dr. Malcolm Ross, Switzerland
|
| |
Analytical chemistry is of major significance in all aspects of the pharmaceutical industry. As staff has become more specialist it is important that people without detailed experience in analytical chemistry understand the fundamental principles involved in order to evaluate the data presented to them. This course is intended to provide a firm basis to enable non-analytical chemists to understand and to evaluate the significance of the data generated in the analytical laboratory. |
|
03/07/2012
3 - Day Course
|
CIP Technology
Lecturer: Mr. Moshe Landsberg
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
22/02/2012
3 - Day Course
|
Analytical Chemistry in the Pharmaceutical Raw Material Laboratory
Lecturer: Dr. Rivka Goldik
|
| |
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. |
|
|
|
|
|
09/02/2012
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 |
|
|
|
TBA
1 - Day Course
|
Efficiency in Quality Operation & Managing Batch Records
Lecturer: Mr. Rafi Maslaton - USA
|
| |
In today's business environment, a quality organization that focuses strictly on compliance while ignoring inefficiency will not succeed. This course discusses efficiency management throughout the quality operations with the main focus on batch record release. While for many years QA was predominantly a compliance organization, and it existence was associated with the cost of doing business, this course will outline how we can manage both compliance and efficiency. |
|
TBA
1 - Day Course
|
Documenting Clinical Studies
Lecturer: Dr. Monica Tocchi, Italy
|
| |
Writing for and about clinical research in human subjects demands special attention to rules. Learn how to write clear and complete documentation of clinical trials. Effective clinical dossiers are approved more quickly, facilitate protocol compliance and enhance trial quality. This ultimately leads to optimal product labeling, allowing successful marketing and maximization of advertising claims. |
|
TBA
2 - Day Course
|
Risk Management Throughout a Drug Lifecycle
Lecturer: Dr. Stanley Garbus
|
| |
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. |
|
|
|
|
|
|
|
|
|
|
|
|
|
14/11/2011
1 - Day Course
|
System & Equipment Qualification & Validation
Lecturer: Ms. Karen Ginsbury
|
| |
Every regulatory inspection and customer audit reviews validation qualification files. Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) as well as validation protocols and reports are all essential elements of a modern pharmaceutical quality system. This one day course will review the GMP requirements relating to validation, guidelines and regulatory expectations as well as inspectional approaches to this critical topic. |
|
14/11/2011
2 Meetings
|
Quality Assurance of Computerized Systems- A Comprehensive Perception
Lecturer: Ms. Daphna Spector-Grossbard
|
| |
Quality Assurance of computerized systems in a regulated environment includes a definition of policy and work procedures, implementation of processes based on software development life-cycle, change control and a constructed validation process which are a direct result of a risk assessment procedure. |
|
|
|
|
|
21/09/2011
1 - Day Course
|
Batch Release
Lecturer: Dr. Rachel Karpel
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TBA
1 - Day Course
|
דה-פירוגנציה
Lecturer: Mr. Eliezer Solomon
|
| |
|
|
25/05/2011
3 - Day Course
|
CIP Technology
Lecturer: Mr. Moshe Landsberg
|
| |
|
|
|
|
03/05/2011
2 - Day Course
|
Planning and performing internal audits according to the GMP
Lecturer: Dr. Orna Dreazen
|
| |
Throughout the course, we shall be discussing the various components of planning an audit based on risk management, performing an audit and drawing conclusions from internal audits. We shall also discuss the evaluation of the effectiveness of the corrective measures implemented by the organization. |
|
|
|
|
|
|
|
|
|
|
|
|
|
TBA
1 - Day Course
|
Tablet Pro
Lecturer: Mr. Michael Tousey, USA
|
| |
Tablet Pro (Professional) is a one day comprehensive course covering tablet press operations. The participant will gain a complete understanding of the importance of tablet press set-up, machine function, operation, and cleaning. |
|
|
|
|
|
|
|
22/12/2010
2 - Day Course
|
Analytical Data at the Service of the QA,
Regulatory & Formulation Staff
Lecturer: Dr. Malcolm Ross, Switzerland
|
| |
Analytical chemistry is of major significance in all aspects of the pharmaceutical industry. As staff has become more specialist it is important that people without detailed experience in analytical chemistry understand the fundamental principles involved in order to evaluate the data presented to them. This course is intended to provide a firm basis to enable non-analytical chemists to understand and to evaluate the significance of the data generated in the analytical laboratory. |
|
|
|
|
|
TBA
2 - Day Course
|
Clinical Project Management
Lecturer: Dr. Stanley Garbus
|
| |
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. |
|
|
|
|
|
|
|
|
|
|
|
|
|
20/10/2010
1 - Day Course
|
GMPs for Printed Packaging Materials
Lecturer: Ms. Karen Ginsbury
|
| |
The goal of the course is to provide participants with an understanding of the inherent dangers and complexity of handling, managing and controlling printed packaging materials so as to minimize the likelihood of inaccuracies in text, of mix-up of versions and / or of product recall because of packaging or labeling mix-ups. |
|
|
|
|
|
TBA
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. |
|
|
|
08/07/2010
1 - Day Course
|
Data Management & Statistical Methods in Clinical Trials
Lecturer: Ms. Tali Azulay, Mr Gil Harari
|
| |
The presentation and interpretation of clinical efficacy and safety results from clinical trials is a core component of regulatory submissions for the approval of medical products and devices. These results, in turn, derive from clinic data which is collected through a regulated process involving clinical trial Sponsors, investigative sites, and contract research organizations.
|
|
|
|
|
|
|
|
|
|
|
|
26/05/2010
1 - Day Course
|
System & Equipment Qualification & Validation
Lecturer: Ms. Karen Ginsbury
|
| |
Every regulatory inspection and customer audit reviews validation qualification files. Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) as well as validation protocols and reports are all essential elements of a modern pharmaceutical quality system. This one day course will review the GMP requirements relating to validation, guidelines and regulatory expectations as well as inspectional approaches to this critical topic. |
|
|
|
|
|
|
|
|
|
TBA
1 - Day Course
|
Analytical Instrument Qualification
Lecturer: Ms. Karen Ginsbury
|
| |
This one day seminar will review the USP Chapter on Analytical Instrument Qualification (AIQ) in the perspective of regulatory requirements (EU and FDA), guidance and expectations. |
|
12/04/2010
2 - Day Course
|
HVAC Systems
Lecturers: Ms. Karen Ginsbury , Uri Harel
|
| |
There is no pharmaceutical facility that is not equipped with a controlled HVAC system. Pharmaceutical facilities are provided with filtered air to ensure an environment that is controlled with respect to particle contamination: both viable and non-viable. This course will provide participants with an understanding of the design of such systems, GMP requirements behind the design, qualification and ongoing operation, maintenance and monitoring. |
|
|
|
|
|
04/03/2010
4 - Day Course
|
Advanced HPLC
Lecturer: Mr. Igal Gozlan
|
| |
|
|
TBA
2 - Day Course
|
Drug Safety
Lecturer: Ms. Orit Neudorfer
|
| |
This course will review the history of drug safety until present days, and describe how safety management has changed its scope to achieve its new challenges. Development of safety strategy, from early development, throughout clinical phases until post-marketing, will be studied, including the establishment of an effective risk management plan. |
|
|
|
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. |
|
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. |
|
|
|
08/02/2010
1 - Day Course
|
Change Management According to the Q10 Guidelines
Lecturer: Ms. Karen Ginsbury
|
| |
This one day, intensive course will address management of change in an industry that has been traditionally skeptical of the need or desire to improve systems that aren’t actually broken. |
|
|
|
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
|
GMP עיקור בסביבת
Professional management: Ms. Yehudith Wexler
|
| |
Isranalytica 2010 – Related Events |
|
TBA
1 - Day Course
|
Auditing Manufacturers of Starting Materials
Lecturer: Ms. Karen Ginsbury
|
| |
At the end of this course participants will understand how to pre-audit, how to schedule and conduct effective audits in limited timeframes and how to follow up on implementation of effective corrective and preventive actions to your audit findings. |
|
|
|
|
|
|
|
TBA
1 - Day Course
|
Multiproduct or Dedicated Facilities
Lecturers: Ms. Karen Ginsbury
|
| |
European regulators and US FDA are currently co-operating in developing an approach to the handling of potent compounds and the use of multi-product as opposed to dedicated facilities. Companies, wanting to be as cost effective as possible, while still ensuring patient (and operator) safety, are often interested in performing campaign work for small volume, but potent products. Both industry and regulators alike, are deliberating as to where the red lines are drawn: which compounds or product categories constitute “too high a risk” and must be manufactured in a dedicated facility. The only category which currently carries a consensus is that of Beta Lactam antibiotics, especially penicillin. What about steroids, products derived from mammalian or animal cells, bacterially derived products especially if using spore-forming organisms. What about pre and post viral inactivation activities. The list is long and complex. This one day course, will enable participants to organize their thoughts, understand current regulations as well as those in the making and will teach you how to perform a rugged risk assessment that is likely to pass close regulatory scrutiny.
The course will address risk elements associated with API manufacture as well as finished product.
|
|
22/12/2009
2 - Day Course
|
Planning and performing internal audits according to the GMP
Lecturer: Dr. Orna Dreazen
|
| |
Throughout the course, we shall be discussing the various components of planning an audit based on risk management, performing an audit and drawing conclusions from internal audits. We shall also discuss the evaluation of the effectiveness of the corrective measures implemented by the organization. |
|
|
|
|
|
|
|
04/11/2009
2 - Day Course
|
Quality Assurance of Computerized Systems- A Comprehensive Perception
Lecturer: Ms. Daphna Spector-Grossbard
|
| |
Quality Assurance of computerized systems in a regulated environment includes a definition of policy and work procedures, implementation of processes based on software development life-cycle, change control and a constructed validation process which are a direct result of a risk assessment procedure. |
|
|
|
|
|
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.
|
|
12/08/2009
1 - Day Course
|
Writing Standard Operating Procedures (SOPs) Workshop
Lecturer: Ms. Karen Ginsbury
|
| |
To review the purpose of SOPs and to provide participants with tools to write their own SOPs that are clear, concise and not open to interpretation. The course will include group exercises and participants will take home an SOP that they have prepared |
|
|
|
|
|
|
|
|
|
|
|
03/06/2009
2 - Day Course
|
Analytical Chemistry for non-analytical chemists
Lecturer: Dr. Malcolm Ross, Switzerland
|
| |
Analytical chemistry is of major significance in all aspects of the pharmaceutical industry. As staff has become more specialist it is important that people without detailed experience in analytical chemistry understand the fundamental principles involved in order to evaluate the data presented to them. This course is intended to provide a firm basis to enable non-analytical chemists to understand and to evaluate the significance of the data generated in the analytical laboratory. |
|
TBA
1 - Day Course
|
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. |
|
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.
|
|
25/05/2009
1 - Day Course
|
GMPs for Printed Packaging Materials
Lecturer: Ms. Karen Ginsbury
|
| |
The goal of the course is to provide participants with an understanding of the inherent dangers and complexity of handling, managing and controlling printed packaging materials so as to minimize the likelihood of inaccuracies in text, of mix-up of versions and / or of product recall because of packaging or labeling mix-ups. |
|
|
|
TBA
1 - Day Course
|
Product & Process Lifecycle ICH Q8,Q9,Q10,Q11
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.
|
|
|
|
TBA
2 - Day Course
|
Out Of Specification results
Lecturer: Ms. Karen Ginsbury
|
| |
In October 2006, FDA finalized its "Guidance for Industry: Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production", EIGHT years after issuing the first draft. |
|
|
|
TBA
3 - Day Course
|
Registering Your Biologics Product with the FDA
Lecturers: Dr. Eli Schmell , Dr. Ruthy Wolfson
|
| |
This three day course is a Step by Step guide for registration of a biotechnology product with the US FDA. The course covers all aspects of product registration from a theoretical and practical point of view. Course content and presentation are divided between lectures covering the guidelines and examples of actual registration stages and practical, workshop application by the course participants. |
|
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. |
|
TBA
2 - Day Course
|
RCA - Root Cause Analysis
Lecturer: Dr. Malcolm Ross, Switzerland
|
| |
Participants will learn how the need to undertake investigations in a systematic manner came about. They will learn the philosophies of different systems that are used in various industries such as CAPA, FMEA, PHA and HAZOP and the difference between reactive and proactive systems. |
|
|
|
|
|
17/12/2008
1 - Day Course
|
GMPs in the Manufacture of Clinical Trials Material
Lecturer: Ms. Karen Ginsbury
|
| |
In July 2008, FDA released a final guidance along with a final rule exempting pharmaceutical manufacturers from the provisions of 21CFR part 211 – GMPs for Finished Pharmaceuticals if manufacturing material for use solely in phase I studies. The EU on the other hand has passed legislation requiring batch release and certification of any investigational medicinal product by a Qualified Person. This course will review the new FDA guidance comparing and contrasting it with the EU GMP requirements in Annex 13. |
|
16/12/2008
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. |
|
|
|
TBA
2 - Day Course
|
Drug Safety
Lecturer: Orit Neudorfer, MD
|
| |
This course will review the history of drug safety until present days, and describe how safety management has changed its scope to achieve its new challenges. Development of safety strategy, from early development, throughout clinical phases until post-marketing, will be studied, including the establishment of an effective risk management plan. |
|
|
|
18/11/2008
1 - Day Course
|
CAPA and a Product Lifecycle Approach
: 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. |
|
|
|
16/09/2008
2 - Day Course
|
Planning and performing internal audits according to the GMP
Lecturer: Dr. Orna Dreazen
|
| |
Throughout the course, we shall be discussing the various components of planning an audit based on risk management, performing an audit and drawing conclusions from internal audits. We shall also discuss the evaluation of the effectiveness of the corrective measures implemented by the organization. |
|
06/08/2008
1 - Day Course
|
Analytical Instrument Qualification - AIQ
Lecturer: Ms. Karen Ginsbury
|
| |
This one day seminar will review the USP Chapter on Analytical Instrument Qualification (AIQ) in the perspective of regulatory requirements (EU and FDA), guidance and expectations. |
|
TBA
2 - Day Course
|
Efficient Management in Quality Operation
Lecturer: Mr. Rafi Maslaton, USA
|
| |
Streamlining your entire supply chain – shorter release time, better quality, higher productivity, lower cost, and improved customer satisfaction – are the goals of any company. This two-day workshop on excellence in operations will focus on achieving these goals while dealing with demanding compliance requirements, increased competition and higher costs. |
|
|
|
17/06/2008
1 - Day Course
|
דה-פירוגנציה
Lecturer: Mr. Eliezer Solomon
|
| |
|
|
|
|
|
|
14/04/2008
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.
|
|
07/04/2008
2 - Day Course
|
RCA - Root Cause Analysis
Lecturer: Dr. Malcolm Ross, Switzerland
|
| |
Participants will learn how the need to undertake investigations in a systematic manner came about. They will learn the philosophies of different systems that are used in various industries such as CAPA, FMEA, PHA and HAZOP and the difference between reactive and proactive systems. |
|
|
|
|
|