Courses and seminars

Gstudy > Courses and seminars
Professional courses, workshops, and seminars, in a variety of fields, provide knowledge and acquaintance with the relevant regulatory requirements and provides the tools for their practical application. The wide variety allows each employee, new or experienced, to choose a topic to specialize in the workplace by implementing highlighted issues based on our field experience. The courses include case studies and group workshops.
Medical Device Catalog
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Quality and Regulation Course for the Medical Device Industry

Nov 1, 2023

By Dana Tirosh B.A. & Gadiel Rothe M.Sc & Adi Azulay, B.Sc., ICQE

Cycle 11

Location: Frontal
Duration: 5 Meetings
Starts at: 09:30
Language: Hebrew
The focus of this course is the practical application of quality requirements and the regulatory tools and pathways available through the US FDA and the EU. During the course, real-world examples and exercises will be used to help you understand the requirements and...
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Medical Devices Quality System Requirements Course

Nov 1, 2023

By Adi Azulay, B.Sc., ICQE

Cycle 11.0

Location: Frontal
Duration: 2 Meetings
Starts at: 09:30
Language: Hebrew
This course will review the fundamentals of how to establish a Culture of Quality and build a Quality System According to ISO 134852016 and 21CFR820, including Document and Record controls (DHF, DMR, DHR, QMS records), Management responsibility, Resource management,...
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Statistical Techniques to Support Validation Seminar

Nov 20, 2023

By Jose (Yossi) Chvaicer, M.Sc.

Cycle 6.0

Location: Frontal
Duration: 1 Meeting
Starts at: 09:00
Language: Hebrew
The aim of the seminar is to get acquainted with and experience statistical tools to support validation. Seminar date – 20/11/23Seminar Hour’s – 09:00-16:00Seminar Location – Building 22 Matam Park, HaifaPrice – 1,200 NIS +...
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Medical Devices Regulations: USA Seminar

Nov 22, 2023

By Dana Tirosh B.A.

Cycle 11.0

Location: Frontal
Duration: 1 Meeting
Starts at: 09:30
Language: Hebrew
This seminar focuses on the practical application of regulatory tools and pathways available through the US market, using real-world examples and exercises to help you understand the regulations and how to comply with them effectively. Seminar date –...
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Test Method Validation TMV Seminar- in Medical Device Industry

Nov 27, 2023

By Jose (Yossi) Chvaicer, M.Sc.

Cycle 6.0

Location: Frontal
Duration: 1 Meeting
Starts at: 09:00
Language: Hebrew
A comprehensive training day on the subject of Test Method Validation (TMV) in the medical device industry.The training includes a regulatory review, main requirements, technical aspects of protocols and reports,Measurement systems, Gauge R&R, statistical methods,...
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Risk Management Seminar

Nov 29, 2023

By Gadiel Rothe M.Sc

Cycle 11.0

Location: Frontal
Duration: 1 Meeting
Starts at: 09:30
Language: Hebrew
The aim of this seminar is to provide concise but complete knowledge and skills required for medical device risk management, according to ISO14971:2019. Seminar date – 29/11/23Seminar Hour’s – 09:30-15:30Location – Building 22 Matam Park,...
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Extended V&V ONLINE course

Dec 4, 2023

By Ossie Milanov, B.A.

Cycle 2.0

Location: Frontal
Duration: 4 Meetings
Starts at: 09:30
Language: Hebrew and English
This course is designed to give you the tools to making an informed decision regarding the testing and the ability to explain this decision in a manner acceptable to the regulatory authorities.▪ Review the issue of product verification and validation, from defining...
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Medical Device Lead Auditors Course

Dec 5, 2023

By Dana Tirosh B.A.

Cycle 3.0

Location: Frontal
Duration: 3 Meetings
Starts at: 09:30
Language: Hebrew
The course aim is to provide the knowledge and skills required to perform 1st 2nd 3rd party audits ofQMS’s to verify compliance with ISO13485:2016 and 21CFR820; under ISO 19011:2018, ISO 17021-1:2015. Physical presence on all three days of the course is mandatory and...
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Qualification of Quality Auditors in the Pharmaceutical Industry Course

Dec 10, 2023

By Orit Harel & Maya Gefen

Cycle 1.0

Location: Online
Duration: 3 Meetings
Starts at: 09:30
Language: Hebrew
This course aims to qualify quality auditors in the pharmaceutical industry.The course entails reviewing the relevant regulations, training the quality controller to perform routine work in the production and packaging departments, and practicing key activities such...
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Process Validation Course for the Medical Device Industry

Feb 4, 2024

By Jose (Yossi) Chvaicer, M.Sc. & Haim Eliyahu, M.Sc.

מחזור 6

Location: Frontal
Duration: 4 Meetings
Starts at: 09:00
Language: Hebrew
The aim of this course is to teach Process Validation for Medical Devices.This content-rich course emphasizes providing participants with methods that will enable them to cope with the Validation challenges in the Medical Device industry under the requirements from...
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Qualification of Validation Engineers in Pharmaceutical Industry for Systems and Equipment Course

Mar 6, 2024

By Elias Morany, M.Sc. & Jose (Yossi) Chvaicer, M.Sc.

מחזור 5

Location: Frontal
Duration: 3 Meetings
Starts at: 09:30
Language: Hebrew
A full training that includes a comprehensive overview for the validation life cycle for systems andequipment in the pharmaceutical industry according to the cGMP requirements. The training provides you with the latest regulatory aspects, validation life cycle review,...
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Batch Record Review by QA\QP Seminar

Cycle 1.0

Location: Frontal
Duration: 1 Meeting
Starts at: 09:30
Language: Hebrew
The purpose of the seminar is to give tools to the QA personnel to check product files before transferring them to final release by QP or another party responsible for release.With an emphasis on important GMP principles such as signatures, corrections, handling device...
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Suppliers Qualification Seminar

By Sivane Toledano, B.Sc.

Cycle 1.0

Location: Frontal
Duration: 1 Meeting
Starts at: 09:30
Language: Hebrew
The aim of this seminar is to learn all relevant aspects of how to implement and/ or improve a comprehensive and integrated Supplier Qualification System that fulfills GMP regulatory...
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Raw Material Testing Seminar

By Yulia Gorodinski (Yezril) B.Sc. & Rivka Goldik, D.Sc.

Cycle 1.0

Location: Frontal
Duration: 1 Meeting
Starts at: 09:30
Language: Hebrew
The aim of this seminar is to demonstrate the process of the qualification of starting materials (APIs and excipients), pharmacopeial monographs specifications, physical and chemical explanation of selectedtests and reduced testing...
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Root Cause Analysis Workshop- for Medical Device Industry

Location: Frontal
Duration: 1 Meeting
Starts at: 09:30
Language: Hebrew
The aim of the course is to learn different methodologies for conducting investigations and to learn basicconcepts and practices of writing investigations in accordance with regulatory...
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Regulatory Strategy Seminar

Cycle 1.0

Location: Frontal
Duration: 1 Meeting
Starts at: 09:30
Language: Hebrew
In the seminar, we will review the different types of Regulatory Strategies and All the steps in building andmaintaining a regulatory strategy.We will discuss the following questions:▪ How to integrate the ISO13485▪ requirement regarding regulatory▪ strategy? How...
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Medical Device Registration across Global Markets and in Israel Seminar

By Dana Tirosh B.A. & Gadiel Rothe M.Sc

1.0

Location: Frontal
Duration: 1 Meeting
Starts at: 09:30
Language: Hebrew
Understanding global and local medical device regulations and requirements and adequate implementation of applicable medical device regulations can significantly expedite the regulatory processes and may help you bringing your medical device to the market faster and...
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Good Distribution Practice GDP of Medicinal Products for Human Use Seminar (according to Ministry of Health procedure #130)

By Elias Morany, M.Sc. & Iris Shamir, M.Sc.

Cycle 1

Location: Frontal
Duration: 1 Meeting
Starts at: 09:00
Language: Hebrew
Ministry of Health procedure #130 defines the required standard for storage and distribution of pharmaceuticals to ensure their safety, efficacy and quality, as main part of the supply chain management.In this seminar we will present practical tools to implement the...
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Management of Changes in Pharmaceutical Industry (Change Control) Seminar

Location: Frontal
Duration: 1 Meetings
Starts at: 09:30
Language: Hebrew
The aim of this seminar is to learn all relevant aspects to implement and/ orimprove your Change Control System fulfilling regulatory requirements.Location – Matam...
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Behaviour during Inspection/ Audit Seminar

Location: Frontal
Duration: 1 Meeting
Starts at: 09:30
Language: Hebrew
The aim of the seminar is to guide the employees participating and presenting in regulatory or customer audits on proper conduct during the...
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Medical Device Single Audit Program (MDSAP) Seminar

By Dana Tirosh B.A.

Cycle 1.0

Location: Frontal
Duration: 1 Meeting
Starts at: 09:30
Language: Hebrew
The medical Device Single Audit Program (MDSAP) was developed to satisfy the needs of multiple regulatory jurisdictions by a single audit of a medical device manufacturer. In this seminar, you will review the fundamentals of MDSAP and gain an understanding of MDSAP...
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GMP Requirements Seminar

Location: Frontal
Duration: 1 Meeting
Starts at: 09:30
Language: Hebrew
The aim of this seminar is to get a basic overview of GMP requirements in pharmaceutical production, to know the most important pharmaceutical regulations and their...
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Design Control Seminar

Location: Frontal
Duration: 1 Meeting
Starts at: 09:30
Language: Hebrew
During this seminar, we will review the requirements for Design controls of medical devices.The requirements for new products and changes to existing products.That includes planning, execution, and the relation to Risk Management, V&V according to ISO13485:2016 and...
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