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.
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Medical Device Lead Auditors Course

Jul 8, 2024

By Dana Tirosh B.A.

Cycle 4.0

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. Course dates:08.7.24 15.7.24 22.7.24 Course Hour’s –...
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Quality and Regulation Course for the Medical Device Industry

Sep 2, 2024

By Dana Tirosh B.A. & Gadiel Rothe M.Sc & Ella Sheiman, D.V.M & Marina Lebel, B.Sc., CQE

Cycle 12

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

Sep 2, 2024

By Dana Tirosh B.A.

Cycle 12.0

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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Process Validation Course for the Medical Device Industry

Sep 11, 2024

By Jose (Yossi) Chvaicer, M.Sc.

מחזור 7

Location: Frontal
Duration: 3 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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Medical Devices Regulations: USA Seminar

Sep 16, 2024

By Ella Sheiman, D.V.M

Cycle 12.0

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. 16.9.24 Seminar Hour’s...
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Statistical Techniques to Support Validation Seminar

Sep 18, 2024

By Jose (Yossi) Chvaicer, M.Sc.

Cycle 7.0

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: 18.09.2024 Seminar Hour’s – 09:00-16:00Seminar Location – Building 22 Matam Park, HaifaPrice – 1,500 NIS +...
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Test Method Validation TMV Seminar- in Medical Device Industry

Sep 22, 2024

By Jose (Yossi) Chvaicer, M.Sc.

7.0

Location: Online + Frontal
Duration: מפגש 1
Starts at: 09:00
Language: עברית
A comprehensive training day on 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, recommended...
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Medical Devices Regulations: Europe Seminar

Sep 23, 2024

By Dana Tirosh B.A.

Cycle 12.0

Location: Frontal
Duration: 1 Meetings
Starts at: 09:30
Language: Hebrew
This seminar focuses on the practical application of regulatory tools and pathways available through the EU market, using real-world examples and exercises to help you understand the regulations and how to comply with them effectively. 23.9.24 Seminar Hour’s...
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Risk Management Seminar

Sep 30, 2024

By Gadiel Rothe M.Sc

Cycle 12.0

Location: Frontal
Duration: 1 Meeting
Starts at: 09:30
Language: Hebrew
This seminar aims to provide concise but complete knowledge and skills required for medical device risk management, according to ISO14971:2019. The seminar date will be updated soon Seminar Hour’s – 09:30-15:30Location; 123 Yigal Alon St., Tel AvivPrice...
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Qualification of Validation Engineers in Pharmaceutical Industry for Systems and Equipment Course

Nov 5, 2024

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

מחזור 6

Location: Frontal
Duration: 3 Meetings
Starts at: 09:30
Language: Hebrew
The training includes a comprehensive overview of 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, DQ/...
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Qualification of Shop Floor QA Personnel in the Pharmaceutical Industry Course

Nov 13, 2024

By Orit Harel & Maya Gefen

Cycle 2.0

Location: Online + Frontal
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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Qualification of analytical lab staff

By Rivka Goldik, D.Sc.

1

Location: Frontal
Duration: 3 Meetings
Starts at: 09:30
Language: עברית
The course is intended to prepare the analytical staff in a GMP lab. The participants will receive useful information about various topics including the Pharmacopoeias, correct use of equipment, and ranking from volumetric apparatus to HPLC. How will I benefit? and why...
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V&V ONLINE Course

By Ossie Milanov, B.A.

Cycle 2.0

Location: Frontal
Duration: 2 Meetings
Starts at: 09:30
Language: Hebrew and English
This course is designed to give you the tools to make 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 the...
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Internal and External Auditors Course for the Pharmaceutical Industry with Iris Shamir

By Iris Shamir, M.Sc.

מחזור 1

Location: Frontal
Duration: 2 Meetings
Starts at: 09:00
Language: Hebrew
Internal and External Auditor Seminar for the Pharmaceutical Industry, based on ISO19011 Principles and the applicable FDA and EU regulations.Focus on Audit of API Manufacturers based on Q7A requirements, and Audit of Excipient Manufacturers. With actual examples,...
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Computerized Software Validation (CSV)-ONLINE

Cycle 4.0

Location: Online
Duration: 3 Meetings
Starts at: 09:00
Language: Hebrew
A full training that includes a comprehensive overview for the validation life cycle for computerized systems in the Pharma and Medical Device industries according to the cGMP, Annex 11, 21 CFR Part 11 requirements and GAMP5 methodology. The training provides you with...
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