Courses and seminars

Gstudy > Courses and seminars

Gstudy is a Unique training center dedicated to employees' professional development in the pharmaceutical, advanced therapy, medical device, and medical cannabis industries.

What do we offer?

  • Professional Courses & Workshops: Covering a wide range of topics, including regulatory requirements, quality standards, GMP processes, validation, and QMS implementation, with tools for immediate application.
  • Lead Auditor Certification Programs: For pharmaceutical and medical device professionals.
  • In-House Training Programs: Customized courses, seminars, and workshops tailored to each client's specific needs.
  • Online Courses (in development): Flexible, on-demand professional training accessible from any device, anytime, anywhere.
  • Expert Webinars: Practical insights and industry updates delivered by seasoned professionals.

Our content is designed for both new and experienced professionals, enabling each participant to select the most relevant learning path for their role and career development.

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Good Distribution Practice (GDP) Seminar for Pharma

Apr 27, 2026

By Iris Shamir, M.Sc.

3.0

Location: Online
Duration: 1 day Seminar
Starts at: 09:30
Language: Hebrew
The GDP (Good Distribution Practice) course provides participants with a comprehensive overview and practical tools for implementing proper distribution principles for pharmaceuticals, in full alignment with international regulatory requirements and authority...
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FDA eSTAR – From Planning to Submission

May 6, 2026

By Avital Levertov, MA

1.0

Location: Online
Duration: 1 Meeting
Starts at: 09:30
Language: Hebrew
eSTAR – From Planning to Submission The course focuses on understanding the FDA eSTAR framework and how it is used for the preparation and submission of medical device applications.It reviews how eSTAR can be applied throughout the submission process – from...
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Medical Device Verification & Validation (V&V) Essentials

May 12, 2026

By Shira Tzur

Cycle 4.0

Location: Online
Duration: 2 Meetings
Starts at: 09:30
Language: Hebrew and English
A professional, practice-oriented course that provides a clear and solid foundation for understanding, planning, and implementing Verification and Validation (V&V) activities as an integral part of medical device product development and the Quality Management...
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Validation and Verification of Analytical Methods – in Pharma & Medical Devices

May 13, 2026

By Anat Sokol, M.Sc

2

Location: Online
Duration: 1 Session
Starts at: 09:30
Language: Hebrew
Validation and Verification of Analytical Methods Professional Training Master the critical regulatory requirements and technical expertise essential for analytical method validation in pharmaceutical manufacturing. This comprehensive one-day seminar provides...
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Autoclave Validation Seminar

May 18, 2026

By Elias Morany, M.Sc.

Cycle 1

Location: Online/Frontal
Duration: מפגש 1
Starts at: 09:30
Language: Hebrew
Autoclave Validation...
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Medical Device Ethylene Oxide (EtO) Sterilization Validation Masterclass

May 28, 2026

By Shira Tzur

1

Location: Online
Duration: 1 Session
Starts at: 09:30
Language: Hebrew
Everything That Matters in Medical Device EtO Sterilization Validation A focused masterclass for teams responsible for planning, validating, and controlling EtO sterilization.   This training course is designed for participants to gain a comprehensive...
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FDA QSR to QMSR Transition Training – Online

Jun 1, 2026

By Sivan Luder, PhD

5.0

Location: Online
Duration: פגישה 1
Starts at: 09:30
Language: עברית
QMSR Transition Training: Adapting to the New FDA Regulation The FDA’s new Quality Management System Regulation – QMSR – has officially replaced 21 CFR Part 820 and incorporates ISO 13485:2016 by reference. For organizations that have not yet fully...
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Internal and External Auditors Certification for Pharmaceutical Industry

Jun 8, 2026

By Iris Shamir, M.Sc.

2.0

Location: Online/Frontal
Duration: 2 Days
Starts at: 09:00
Language: Hebrew
A comprehensive training program designed to provide pharmaceutical quality assurance professionals with the theoretical knowledge and practical skills required for conducting internal audits and supplier assessment audits. The course combines regulatory theory,...
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Medical Device Lead Auditor Certification Course

Jun 17, 2026

By Dana Manaim-Tirosh

Cycle 8.0

Location: Frontal
Duration: 3 Days
Starts at: 09:00
Language: Hebrew
  ISO 13485 Lead Auditor Course The objective of this course is to provide participants with the knowledge and practical skills required to perform first-party, second-party, and third-party audits of a Quality Management System in accordance with ISO 13485:2016,...
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Validation and Monitoring of HVAC Systems and Clean Rooms Training

Jul 6, 2026

By Jose (Yossi) Chvaicer, M.Sc. & Meir Podriadchik Paz

Cycle 6.0

Location: Online + Frontal
Duration: 2 Days
Starts at: 09:00
Language: Hebrew
Professional Certification Course | 2-Day Intensive Program Take Your Cleanroom & HVAC Expertise to the Next Level!    Working in pharma or medical devices? If HVAC systems or cleanrooms are part of your daily reality, this course is built for you.     Why...
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Pharmaceutical Quality Assurance Certification Course – Pharma

Jul 16, 2026

By Maya Gefen, M.Sc & Meir Podriadchik Paz

3

Location: Online
Duration: 3 Sessions
Starts at: 09:00
Language: Hebrew
Pharmaceutical Quality Assurance Certification Course Quality on the shop floor in the pharmaceutical industry    Looking to advance your career in the pharmaceutical industry with a field-oriented, hands-on role? This Pharmaceutical Quality Assurance...
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Cleaning Validation Seminar for the Pharmaceuticals Industry

Jul 20, 2026

By Iris Shamir, M.Sc.

Cycle 4.0

Location: Online + Frontal
Duration: 1 Meeting
Starts at: 09:00
Language: Hebrew
The seminar will review the regulatory requirements and guidelines of the cleaning validation lifecycle.In the seminar, we will learn about examples of authorities’ observations, how to avoid common mistakes, and practice. The topics of the seminar: -Details of...
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Validation Engineers Qualification Course for Systems and Equipment – Pharmaceutical Industry

Oct 12, 2026

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

10

Location: Online + Frontal
Duration: 3 Days
Starts at: 09:00
Language: Hebrew
Join our specialized training course designed for Validation Engineers in the Pharmaceutical Industry, focusing on the validation life cycle for systems and equipment according to cGMP requirements. This hands-on program provides a deep understanding of: The validation...
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Medical Device ISO 13485 Quality Management System Requirements Training

Oct 14, 2026

By Dana Manaim-Tirosh

Cycle 16.0

Location: Frontal
Duration: 2 Days
Starts at: 09:00
Language: Hebrew
This comprehensive two-day course provides in-depth knowledge and practical skills for implementing and maintaining ISO 13485:2016 Quality Management Systems in medical device organizations. Participants will gain essential competencies in establishing effective...
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Medical Device Quality and Regulation Training Course – Full

Oct 14, 2026

By Sivan Luder, PhD & Avital Levertov, MA

Cycle 16.0

Location: Frontal
Duration: 5 meetings
Starts at: 09:30
Language: Hebrew
Medical Device Quality and Regulation Course This comprehensive 5-day course provides in-depth knowledge and practical skills on Medical Device Quality Management Systems and Regulatory Requirements. Participants will learn how to establish and maintain effective...
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Navigating FDA Requirements-Quality & Regulatory Essentials for Medical Devices

Oct 28, 2026

By Avital Levertov, MA

Cycle 16.0

Location: Frontal
Duration: 1 Meeting
Starts at: 09:30
Language: Hebrew
FDA Requirements: Quality & Regulatory Essentials for Medical Devices – 1-Day Seminar The seminar will focus on introducing the key medical device regulations, the main FDA regulatory pathways for 510(k) clearance, De Novo granting, or PMA approval based on...
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Medical Device EU MDR Seminar – Regulation (EU) 2017/745

Nov 4, 2026

By Dana Manaim-Tirosh

Cycle 16.0

Location: Frontal
Duration: 1 Meetings
Starts at: 09:00
Language: Hebrew
Medical Device EU MDR 1-Day Seminar 4/11/2026   900-1600 This comprehensive seminar provides essential knowledge for navigating the EU Medical Device Regulation (MDR) 2017/745 requirements. Designed for medical device professionals, this program focuses on the...
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Medical Device Risk Management Seminar (ISO 14971:2019)

Nov 11, 2026

By Sivan Luder, PhD

Cycle 16.0

Location: Frontal
Duration: מפגש 1
Starts at: 09:30
Language: עברית
This interactive training provides a comprehensive understanding of ISO 14971:2019 and ISO/TR 24971:2020, covering the application of risk management principles to medical devices throughout the product life cycle. Participants will gain practical skills to identify...
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Process Validation (PV) for Medical Device Industry

Nov 16, 2026

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

Cycle 11

Location: Online + Frontal
Duration: 3 Days
Starts at: 09:00
Language: Hebrew
3-Day Comprehensive Training Program Master the essential requirements for process validation in medical device manufacturing. This intensive program covers regulatory compliance, statistical analysis, and measurement system validation to ensure robust manufacturing...
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FDA QSR to QMSR Transition Training – Online

Dec 14, 2026

By Sivan Luder, PhD

6.0

Location: Online
Duration: פגישה 1
Starts at: 09:30
Language: Hebrew
QMSR Transition Training: Adapting to the New FDA Regulation The FDA’s new Quality Management System Regulation – QMSR – has officially replaced 21 CFR Part 820 and incorporates ISO 13485:2016 by reference. For organizations that have not yet fully...
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Process Validation with focus on Quality Aspects for the pharmaceutical industry – On-demand

By Maya Gefen, M.Sc

Location: Online/Frontal
Duration: 1 day Seminar
Starts at: 09:00
Language: Hebrew
This course offers an in-depth overview of process validation in the pharmaceutical industry, following FDA and EMA regulations. It covers key regulatory terminology, validation approaches, Quality by Design (QbD) principles, investigation methodologies, and continuous...
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Cross-Contamination Seminar for the Pharmaceutical Industry – Coming Soon

By Iris Shamir, M.Sc.

מחזור 1

Location: Online/Frontal
Duration: מפגש 1
Starts at: 09:30
Language: עברית
...
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Computerized Software Validation (CSV)

By Sara Levy

Cycle 6.0

Location: Online + 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...
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GMP Laboratory Analyst Qualification

By Rivka Goldik, D.Sc.

Location: Online + Frontal
Duration: 2 Days
Starts at: 09:30
Language: עברית
Overview A practical two-day course designed to qualify analysts for compliant work in QC laboratories within the pharmaceutical and medical device industries. The course focuses on the practical implementation of pharmacopeial requirements, specifically USP-NF and EP,...
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MDSAP Audits – Coming Soon

מחזור 1

Location: Online/Frontal
Language: Hebrew
...
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