“The expert in asepsis and sterility assurance“

Quality and Compliance Training

Quality and Compliance Training

If your staff understand the quality systems you use and why they are important, they’ll be more effective at implementing them – improving your products.
And when your company has clearly defined the roles and skills required for each position within your company that is relevant to quality and compliance, you take a big step towards ensuring your quality goals are met.

These are the two main areas where training from Galenisys can help you substantially improve your quality systems, and the competence of your staff.
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 quality systems – and their day-to-day implementation.

Training for your staff

Understanding the ‘what’ and ‘why’ of quality systems is essential if your staff are to implement them effectively.

Our bespoke training for your staff covers areas such as:

  • Product registration with the FDA and the European authorities
  • The legal requirements for quality and compliance in Europe and the United States of America
  • The organisation and ways of working of the European Authorities and of the FDA

Defining quality and compliance positions in your company

Galenisys can create tailor-made programmes for defining, explaining and providing training for all the key quality and compliance roles within your company.This process will also include giving you the means to evaluate the competency of your staff and the resources to promote the development of individuals.
Each of our targeted training courses in quality systems and pharmaceutical expertise can be held in either French or English and tailored to your needs.

Training for regulatory bodies

If you work to regulate the pharmaceutical industry, our training courses can help you as well.

Our consultants have worked closely with both European and American regulatory bodies in the past, and can provide the detailed instruction your inspectors need to properly and consistently evaluate the quality systems of pharmaceutical manufacturers around the world.
Our decades of experience will give each participant in our training courses reliable insight into industry practices and how to approach and evaluate manufacturers in different countries and markets.

Examples of our courses include:

Manufacturing, storage and distribution practices

  • Good manufacturing practices (GMPs)
  • Implications for manufacturing and control activities
  • Good storage and distribution practices
  • The storage, control and use of printed packaging materials
  • Good maintenance and engineering practices
  • The design, use, control and maintenance of water systems
  • 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
  • Change control
  • Performance monitoring for quality and compliance
  • Complaints and ADEs
  • Reporting for quality and compliance
  • The principles of Qualification, Validation and Calibration
  • The principles of documentation management
  • Data management
  • Auditing

Maintaining sterility and dealing with nonconformity

  • Sterility assurance – how to achieve it
  • Sterilisation methods and their control
  • Aseptic filling – design and control
  • Solid dose manufacture and the prevention of cross contamination
  • Nonconformity detection, investigation and resolution
  • The management of Out of Specification (OOS) and invalid results

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 11, rue Notre Dame de
Nazareth 75003 Paris – France
+33 (0)1 45554414

Galenisys USA Inc. 4359, Ravinewood
Dr. Commerce Mi 48382 USA
(248) 676 0521