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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Quality and Regulation Course for the Medical Device Industry

Feb 5, 2025

By Dana Tirosh B.A. & Ella Sheiman, D.V.M & Sivan Luder, PhD

Cycle 13

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 Device Quality Requirements Course

Feb 5, 2025

By Dana Tirosh B.A.

מחזור 13

Location: Frontal
Duration: 2 מפגשים
Starts at: 09:30
Language: עברית
This course provides a comprehensive understanding of ISO 13485:2016 and 21 CFR 820 standards, focusing on building a quality culture and implementing Quality Management Systems (QMS). Key topics include: Document and record control (QMS, DHF, DMR, DHR) Design and...
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Computerized Software Validation (CSV)

Feb 16, 2025

By Sara Levy

Cycle 4.0

Location: Frontal
Duration: 3 Meetings
Starts at: 09:00
Language: Hebrew + English
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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Medical Devices Regulations: USA Seminar

Feb 19, 2025

By Ella Sheiman, D.V.M

Cycle 13.0

Location: Frontal
Duration: 1 Meeting
Starts at: 09:30
Language: Hebrew
This seminar highlights the practical application of regulatory tools and pathways within the US market, with a special emphasis on the new requirements of QMSR. Through real-world examples and interactive exercises, participants will gain a clear understanding of the...
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AI for Quality Assurance: Practical Ways It Can Help You

Feb 20, 2025

By Moran Dvora

2.0

Location: Online
Duration: 4 Hours
Starts at: 09:00
Language: Hebrew
In recent years, Generative AI (GenAI) technologies have been offering new supporting tools for various processes, including quality assurance. This training will present ways to integrate AI as a supportive tool in a smart and simple way to streamline daily...
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Medical Devices Regulations: Europe Seminar

Feb 26, 2025

By Dana Tirosh B.A.

Cycle 13.0

Location: Frontal
Duration: 1 Meetings
Starts at: 09:30
Language: Hebrew
This seminar emphasizes the practical implementation of regulatory tools and pathways within the EU market. Through real-world examples and hands-on exercises, participants will gain a clear understanding of the regulations and learn how to achieve compliance...
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GDP Seminar

Feb 27, 2025

By Orit Harel

1.0

Location: Online
Duration: 1 day Seminar
Starts at: 09:00
Language: Hebrew
The seminar offers a comprehensive overview of the key principles and practices of Good Distribution Practice (GDP), focusing on the following critical topics: Regulations, Standards, and Guidelines: Explore the legal frameworks and industry standards that govern GDP...
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Risk Management Seminar

Mar 5, 2025

By Sivan Luder, PhD

Cycle 13.0

Location: Frontal
Duration: 1 Meeting
Starts at: 09:30
Language: Hebrew
This seminar focuses on providing practical knowledge and skills for effective risk management in medical devices, based on the ISO 14971:2019 standard. It aims to deliver a comprehensive understanding of the latest regulatory requirements and the risk management...
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Process Validation Course for the Medical Device Industry

Mar 11, 2025

By Jose (Yossi) Chvaicer, M.Sc. & Hadar Shoham, B.Sc.

מחזור 8.0

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 Device Lead Auditors Course

Mar 12, 2025

By Dana Tirosh B.A.

Cycle 5.0

Location: Frontal
Duration: 3 Meetings
Starts at: 09:30
Language: Hebrew
Lead Auditor Training Course in Medical Device Quality Management SystemsIncluding Comprehensive Understanding and Practical Application of Audit Stages Course Objective:To provide the necessary knowledge and skills to conduct first, second, and third-party audits of a...
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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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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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