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
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.
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.
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.
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.
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.
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.
Bio-Chem articles for you
-
Risk Assessment and Risk Management in the Medical and Pharmaceutical IndustriesRisk Assessment and Risk Management in the Medical and Pharmaceutical Industries
Articles, Medical Device, Medical Device, Phama/BioTech, Phama/BioTech articles, איכות ו-GxP, אמ”ר, ולידציה והסמכות, מצוינות תפעולית, פארמה וביוטק
Risk Assessment and Risk Management in the Medical and Pharmaceutical Industries
The medical and pharmaceutical industries are involved in new product development and manufacturing of medicines, medicinal products, biological products, [...]
Fermentation in the biopharmaceutical industry
1. Background Many biopharmaceutical and biological products are based on (different) cell-type fermentation. Biopharmaceutical products can be either intracellular [...]
New drug development and regulation from pre-clinical to clinical trials
Background and history The FDA (US Food and Drug Administration) was established in 1901 as a bureau of the [...]