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Our courses & webinars for the pharma & medical industries

Join Bio-Chem training and courses for applied knowledge

Courses and training taught by Eran Yona in the diverse fields of pharma, medical and product development.

Knowledge is power. Training is an essential part of the success of any company and individual. We live in a very dynamic industry. We want to make sure everyone is appropriately trained and exposed to the most up to date information available to ensure the achievement of our client’s long term success. As a consulting company, we believe that our clients should be as independent as possible after we finish the project we were hired to do. We have already conducted dozens of training and courses that led our customers to success, and can provide tailor-made training or courses for any position, job or role needed by the company, on site or remotely. We at Bio-Chem have the specific goal of improving companies’ capability, capacity, productivity and performance.

Our Courses:

  • Introduction to validation for cleaning processes

  • Introduction to pharmaceutical manufacturing technology

  • Introduction to clean rooms

  • Introduction to Risk Analysis, Risk Evaluation and Risk Management

  • Introduction to creating solids – tablets, capsules and granules

  • Introduction to validation processes – IQ, OQ, PQ, PPQ
  • Introduction to cross-contamination in the pharmaceutical industry

  • Introduction to Quality Management Systems in the Pharma Quality System PQS

  • Introduction to GMP and quality assurance in the pharma industry + workshop for writing procedures and production instructions

  • Introduction to the transition from research to clinical trials and commercial production of pharmaceuticals

  • Introduction to regulatory strategy, classification / screening, health and digital health trends and challenges

  • Introduction to advanced labs and principles in lab design, lab certification and safety

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Our services

Our consulting services

Research and development

Consulting in a variety of areas, including design, research laboratories and clean rooms, development technologies, investor business presentations, regulatory strategies, market analysis, clinical trial protocols, GLP, GCP, ISO 17025, calibration, CMC and 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 biomed regulations and in accordance with GxP principles.

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Manufacture and packaging

Consulting on manufacturing plant design, manufacturing process development and engineering, selecting the most appropriate technology, process scale-up, technology transfer, GMP, process improvement, yield optimization and improvement, employee training, validation of equipment, systems, and production and cleaning processes.

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GxP, quality and validation

Advises, establishes, accompanies and upgrades various types of quality management systems, offers GMP training and courses, coordinates adoption of GxP principles, ISO 13485, quality assurance and preparation for global regulatory audits while conducting risk analysis and evaluation, and verification and validation of equipment, systems, software, test methods, manufacturing and cleaning processes, until  a successful audit outcome is obtained.

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Regulation and registration

Regulatory consulting and drug registration,  medical devices, CE mark, dietary/nutritional supplements and cosmetics in Israel and worldwide, building a smart regulatory strategy, helping to prepare documents and meet requirements in a professional manner, in a short time, product labeling, shelf life and graphics, import licenses and meetings with regulatory bodies, until approval  (marketing authorization) is received.

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Software and systems

Digital healthcare consulting, software development and medical applications in accordance with US  FDA 21 CFR part 11 / EU Annex 11 / US HIPAA / EU GDPR requirements, ISO 13485/ISO 27001/ISO 27799, CE marking, risk assessment, verification and validation of software and control systems until marketing authorization (approval) is obtained.

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