Galenisys Pharmaceutical Consultants - Pharma Consulting

“The expert in asepsis and sterility assurance“

Training

Galenisys has created more than 230 training modules in both English and French that cover all the activities of the Pharmaceutical industry, from basic GMP’s to the detailed aspects of Steriles manufacturing.

Our consultants have practical experience in conducting training sessions in the Emerging Markets. These training sessions are followed by workshops to ensure that the participants have gained a good understanding of the subject.

Each one of our training courses is specially designed to meet the needs of your company and your employees and will make a practical difference to the management of your systems and their day to day implementation. Understanding the “what” and “why” of the systems is essential if your staff are to implement them effectively.

Galenisys can support you in training your staff and also in developing your business if you plan to export your products to the EU and/or the USA

Business development

Our consultants have interacted successfully with both European and American regulatory authorities in the past. They understand the issues that the European and FDA’s inspectors focus on and their ways of working.

Our training covers areas including:
  • Product registration with the European authorities or with the FDA
  • Legal requirements for quality and compliance in Europe and the USA
  • The organisation and the ways of working of European authorities and of the FDA
  • How to prepare and manage regulatory inspections from the EMeA and FDA

Our decades of experience will give each participant on our training courses reliable insight into industry practices.

Training for your staff

Galenisys can create tailor made programmes for defining, explaining and providing training for all the key roles within your company. This process will also include giving you the means to evaluate the competencies of your staff and the resources needed for promoting the personnel development.
Each of our training courses can be held in English or French. They can be specifically tailored to your needs.

Our courses cover:

Manufacturing, control, storage and distribution practices

  • Good RM storage practices
  • Storage, control and use of printed materials
  • Global Good manufacturing practices
  • Qualifications and validations. Focus on cleaning validations
  • Calibrations
  • Good Maintenance and Engineering practices
  • Processes validations
  • Process robustness
  • Risk analysis and risk management
  • Manufacturing. Prevention of cross contaminations
    • Sterility assurance. How to achieve it
    • Sterilisation methods and their control
    • Aseptic filling. Design and control
  • Non conformity detection, investigation and resolution
  • The management of OOS and invalid results
  • CAPA’s
  • The design, use, control and maintenance of AHU’s and Water systems
  • Good Finished Products storage and distribution practices
  • The control and management of suppliers and sub-contractors

Regulation and compliance

  • How to prepare and manage regulatory inspections
  • Compliance with your commitments in regulatory dossiers and how to maintain them
  • The principles of Calibration, Qualification and Validation
  • Change control
  • Data management
  • Performance monitoring for Quality and Compliance
  • Reporting for Quality and Compliance
  • Complaints and ADEs
  • The principles of documentation management
  • Auditing

Please look at our list of training modules. If you do not find what you are looking for then do not hesitate to contact us. We can tailor training to meet your needs.

Galenisys Pharmaceutical Consultants - Pharma Consulting