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.

Qualification of Shop Floor QA Personnel in the Pharmaceutical Industry Course

Nov 20, 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...

Qualification of Validation Engineers in Pharmaceutical Industry for Systems and Equipment Course

Nov 25, 2024

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

מחזור 6

Location: Online + 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/...

Medical Devices Regulations: Europe Seminar

Dec 9, 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. 09.12.2024 Seminar hours –...

Computerized Software Validation (CSV)

Dec 15, 2024

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...

V&V ONLINE Course

Dec 17, 2024

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...

AI for Quality Assurance: Practical Ways It Can Help You

Dec 19, 2024

By Moran Dvora

1.0

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 QA...

Medical Device Lead Auditors Course

Jan 8, 2025

By Dana Tirosh B.A.

Cycle 5.0

Location: Frontal
Duration: 4 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:08.1.25 15.1.25 22.1.25 29.1.25 Course Hour’s...

Quality and Regulation Course for the Medical Device Industry

Feb 5, 2025

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

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...

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...

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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