Current Good Manufacturing Practices for Hospitals and for (Bio) Pharmaceutical Products

In the past decade regulations for the manufacture of therapeutic and diagnostic reagents for clinical use in vivo have become stricter. In recent years there is now also a focus on the use of pharmaceuticals, pharmacists and other medical staff in hospitals. Quality Assurance and Control throughout the development at all production stages as well as during clinical trials and administration to patients is necessary, in addition to the testing of end products.
In the Life Science industry as well as in the Biopharmaceutical industry this all needs to be in line with and according to the guidelines from the regulatory authorities such as the FDA. This involves the production utility unit, equipment (fermentor/bioreactor), process development and production, as well as optimal training of personnel working in pharmaceutical production areas or in hospitals.

The emergence of new products from biopharmaceutical industries, such as gene-therapy, stem cell therapy, vaccines and monoclonal antibodies, have added a dimension to Requirements for the Registration and bio-safety testing. It is also essential to be fully aware of these issues when products are still at the research stage, to achieve cost-effective product development and high quality products and to avoid delay at later stages.

This 3 day cGMP training course for manufacturers and for staff working in hospitals will give you an introduction and overview of current EU as well as USA-FDA regulatory requirements and GMP for biotechnological products and production processes as well as for medical devices and/or will update your present knowledge in this rapidly developing field. Furthermore a workshop will be held dealing with case studies and GMP problems and solutions. In addition during this course you will visit and be guided through some new (GMP) facilities for the manufacture of (bio) pharmaceuticals such as monoclonal antibodies.

Who Should Attend

This course is designed for personnel involved in the development, production, validation, control and registration of pharmaceutical products derived from biotechnological processes within the (bio)pharmaceutical and related health care industries as well as decision makers such as:

  • Production managers and supervisors
  • QA and QC personnel involved in self-inspections
  • Personnel involved in Regulatory Affairs
  • Clinical trial supply personnel and hospital staff members
  • Pharmacists
  • Personnel involved in the registration requirements and the set up of the registration dossier
  • Researchers in the development of bio(techno)logical products for clinical use
  • Executives responsible for these sections

Dates courses:

We don’t have courses scheduled at this moment. But if you would like to follow our courses, we kindly ask you to call or mail us. When we have enough participants we will organize courses.

In-house courses are an ideal solution for ten or more people and are very cost-effective. We come to you at a time and date suited to your organisation.

Please contact us if you are interested in a detailed offer.