Bioforum courses2020-06-16T11:21:12+00:00

Bioforum courses

Join Bio-Chem training and courses for applied knowledge

קורסים, הדרכות והכשרות בתחומים מגוונים המועברים ע”י ערן יונה בתחומי הפארמה, המדיקל ופיתוח מוצר.

על המרצה: יועץ GxP, טכנולוגיות ואיכות בעל ניסיון של למעלה מ-20 שנה בתחומי המחקר, טכנולוגיות, ניהול ייצור ופיתוח תהליכים בתעשיות הביומד.
במסגרת עבודתו ב-Bio-Chem ניהל פרויקטים רבים בתחומי הפארמה והמדיקל, עסק בתכנון מפעלים ומתקני יצור, הוביל פרויקטי פיתוח מוצרים, איכות ורגולציה וליווה חברות ביומד רבות להצלחה בהתאם לדרישות ה-FDA ורשויות הבריאות הארופאיות.

כמו כן, ערן מרצה במגוון קורסים והדרכות רבות בתעשיות הפארמה, המדיקל ומדעי החיים .

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    Research and development

    Consultancy in a variety of areas including design, research labs and clean rooms, development technologies, investor business presentations, regulatory strategy, market analysis, clinical trial protocols, GLP, GCP, ISO 17025, calibration, CMC, professional training.

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    Design and engineering

    Designing factories, clean rooms and laboratories, engineering documentation, certification, technology selection, process engineering, and validation with a combination of theoretical knowledge, practical experience, and in-depth understanding of the biometrics regulation and principles and in accordance with the GxP principles.

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    Manufacture and packaging

    Consultancy in manufacturing plant design, development and engineering of manufacturing processes, selecting the most appropriate technology, process gable, technology transfer, GMP, process improvement, utilization optimization and improvement, employee training and equipment validation, systems, production processes and cleaning.

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    GXP, Quality Validation

    Advises, establishes, accompanies and upgrades systems of various types of quality management, executes GMP trainings and courses, assimilates the company’s GxP principles, ISO 13485, assures quality and prepares for global regulatory audits while conducting risk analysis and evaluation, equipment, systems, software, testing methods, manufacturing processes. And cleanliness until successfully audited.

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    Regulation and registration

    Regulatory consulting and drug registration, EMC, CE Mark, nutritional and cosmetic supplements in Israel and worldwide, building a smart regulatory strategy, helping to prepare documents and requirements in a professional manner, in a short time, outlining the product, shelf life and graphics, import certifications and meetings with regulatory bodies and up to approval .

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    Software and systems

    Digital healthcare consulting, software development and medical applications in accordance with 21CFR part 11 / Annex 11 / HIPAA / GDPR requirements, ISO 13485/27001/27799, CE marking, Risk Assessment, and software validation and control systems up to marketing approval.

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