Training

 

 

Training programs for solid peak performance Globalization, changes and updates in guidelines, latest trends of compliance and audit and regulatory authorities such as FDA require constant adaptations and regular trainings of your staff.   Nagano Science offers training services based on thorough research of updates and trends in the international guidelines. Moreover, we have implemented tools like regular information systems to inform and train industrial personnel and specialists with regular public information events or customized events at your site.   The training programs range from basic knowledge to highly specialized information systems, covering updates and changes of guidelines, inspection and trend analysis of authority activities to help you know the latest in, technical development and market relevant trends.

Operator training We provide basic operator training at the time of installation of the stability chambers and additional operator training to inform about changes and updates or relevant functions of the equipment to assure the correct operation of Nagano Science's equipment at all times.   Separate and regular technical trainings are offered to our partners to guarantee competence and permanent excellence in customer service wherever our customers are and will be.   GMP and FDA information and training programs We offer education and training for GMP and GMP PIC/S guidelines where we introduce FDA audit cases regarding the storage stability testing process and inform about global trends and updates of guidelines, regulations and authority activities.   Training for stability testing This module provides various training sections, ranging from basic knowledge of storage stability testing and conditions of ICH guidelines to validation principles and equipment reliability assurance, implementation of safety and security measures as well as specific and process related subjects requested by customers.   GMP training This course offers training and information for the general interpretation of control and compliance to provide high quality pharmaceutical products in accordance to the latest GMP standards.   Global audit training The module introduces and informs about the latest auditing practices and trends by international authorities and gives an understanding how to maintain and prepare the facility for international and external audits and certifications.    Examples of education programs previously provided ● Explications for stability testing guideline ICH Q1A (R2) ● Outline for photo-stability testing ● Stability testing for transportation of pharmaceuticals and contingency planning ● Implementation of ICH chapters Q8, Q9 and Q10 in storage stability testing processes ● FDA audit cases (FDA 483 audit observations), FDA warning letters and stability testing trends The list of services you may engage Nagano Science for include:   ● Risk Management ● Risk Assessment ● Back-up storage ● Validation ● Daily inspection ● Operator training ● Documentation ● QMS and SOP