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.

FDA QSR to QMSR Transition Training – Online

Jan 25, 2026

By Sivan Luder, PhD

3.0

Location: Online
Duration: 1 Meeting
Starts at: 09:30
Language: Hebrew
QMSR Transition Training: Adapting to the New FDA Regulation This training provides a comprehensive overview of the U.S. FDA’s new Quality Management System Regulation (QMSR), which replaces the existing Quality System Regulation (21 CFR Part 820) and incorporates...

Process Validation (PV) for Medical Device Industry

Jan 26, 2026

By Jose (Yossi) Chvaicer, M.Sc.

Cycle 10

Location: 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...

Medical Device ISO 13485 Quality Management System Requirements Training

Jan 28, 2026

Cycle 15.0

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...

Medical Device Quality and Regulation Course – 5Days

Jan 28, 2026

By Sivan Luder, PhD & Avital Levertov, MA

Cycle 15.0

Location: Frontal
Duration: 5 meetings
Starts at: 09:30
Language: Hebrew
Essential Training in Quality and Regulatory Affairs for the Medical Device Industry This course focuses on an in-depth understanding and practical implementation of quality standards, U.S. and EU medical device regulations, and risk management in the field. Through...

Metrology, Measurements & Calibration Training

Jan 29, 2026

By Elias Morany, M.Sc.

מחזור 1

Location: Online/Frontal
Duration: מפגש 1
Starts at: 09:30
Language: עברית
...

FDA QSR to QMSR Transition Training – Online

Feb 1, 2026

By Sivan Luder, PhD

4.0

Location: Online
Duration: פגישה 1
Starts at: 09:30
Language: עברית
QMSR Transition Training: Adapting to the New FDA Regulation This training provides a comprehensive overview of the U.S. FDA’s new Quality Management System Regulation (QMSR), which replaces the existing Quality System Regulation (21 CFR Part 820) and incorporates...

Navigating FDA Requirements-Quality & Regulatory Essentials for Medical Devices

Feb 11, 2026

By Avital Levertov, MA

Cycle 15.0

Location: Frontal
Duration: 1 Meeting
Starts at: 09:30
Language: Hebrew
FDA Requirements: Quality & Regulatory Essentials for Medical Devices – 1-Day Seminar This seminar highlights the practical application of regulatory tools and pathways within the US market.  Through real-world examples and interactive exercises,...

Validation Engineers Pharmaceutical Industry: Qualification Course for Systems and Equipment

Feb 16, 2026

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

8

Location: 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...

Medical Device EU MDR Seminar – Regulation (EU) 2017/745

Feb 18, 2026

Cycle 15.0

Location: Frontal
Duration: 1 Meetings
Starts at: 09:30
Language: Hebrew
Medical Device EU MDR 1-Day Seminar   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 practical application...

Medical Device Risk Management Seminar (ISO 14971:2019)

Feb 25, 2026

By Sivan Luder, PhD

Cycle 15.0

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 comprehensively understand the latest regulatory requirements and the risk management process throughout...

Out of Specification (OOS) Investigations: Advanced Training for Pharmaceutical QA

Mar 3, 2026

By Jenny Sverdlova B.Sc.

2.0

Location: Online
Duration: 1 Session
Starts at: 09:30
Language: Hebrew
Transform Your Out-of-Specification (OOS) Investigation Approach with Expert-Led Training Join our comprehensive seminar designed to elevate your Out-of-Specification investigation capabilities. This intensive session combines regulatory guidance review, real-world...

Medical Device EtO Sterilization Validation Masterclass

Mar 11, 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...

Computerized Software Validation (CSV)

Mar 16, 2026

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...

Batch Record Review and Release Seminar in the Pharmaceutical Industry

Mar 25, 2026

By Rina Harari, B.Sc

1.0

Location: Online
Duration: 1 Session
Starts at: 09:30
Language: Hebrew
Course Description: A seminar designed to provide Quality Assurance professionals with essential tools for reviewing product batch records prior to final release by the Qualified Person (QP) or other authorized personnel responsible for product release. The training...

Medical Device Verification & Validation (V&V) Essentials

Apr 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...

GDP (Good Distribution Practice) Seminar

Apr 27, 2026

By Iris Shamir, M.Sc.

2.0

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 and medical devices, in full alignment with international regulatory requirements and...

Validation and Verification of Analytical Methods – in Pharma & Medical Devices

May 13, 2026

By Anat Sokol, M.Sc

2

Location: Frontal
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...

Mastering Vendor Management in Clinical Research

May 14, 2026

By Nadia Niemeryanski, M.P.H, B.Sc

1

Location: Online/Frontal
Duration: 1 Meeting
Starts at: 09:30
Language: Hebrew
Mastering Vendor Management in Clinical Research Practical strategies for selection, qualification, oversight, and collaboration with CROs and other clinical vendors This course provides a practical and comprehensive overview of clinical vendor management — from...

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...

Medical Device Lead Auditor Certification

Jun 10, 2026

מחזור 8

Location: Frontal
Duration: 3 מפגשים
Starts at: 09:00
Language: עברית
...

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...

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...

Internal and External Auditors Certification for Pharmaceutical Industry

Dec 23, 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,...

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...

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
...

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,...

MDSAP Audits – Coming Soon

מחזור 1

Location: Online/Frontal
Language: Hebrew
...
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