Beschreibung
e-Learning: Responsible Person | FvP Fachtechnisch verantwortliche Person
The Responsible Person (RP/FvP) – A Key Role in the Swiss GMP and GDP Landscape
The Fachtechnisch verantwortliche Person (FvP) – or Responsible Person – is the recognized, named representative and primary point of contact for regulatory authorities. The RP ensures that all necessary measures are in place to comply with national and international laws and regulations within the license-holding organization.
Acting as the technical and operational supervisor, the RP oversees compliance and ensures the proper handling of medicinal products.
In this e-learning module, we introduce you to the role and responsibilities of the RP, focusing specifically on medicinal products in the contexts of manufacturing and distribution.
Beyond the legal framework and key terminology, the spotlight is on the individual in the RP role. You will learn about qualification requirements, competencies, and responsibilities. Real-world tasks and everyday scenarios round off the training content.
Content
- Legal Foundations
-
- HMG (Therapeutic Products Act)
- AMBV (Medicinal Products Licensing Ordinance)
- SMI.TI
- GMP/GDP rules and international guidelines
-
- Key Terminology
-
- Swissmedic
- Marketing Authorisation Holder
- Establishment Licence Holder
- Manufacturing Licence
- Wholesale Licence
- Manufacturer
-
- The RP as a Role
-
- Importance and significance
- Qualification requirements
- Professional and legal expectations
-
- Duties and responsibilities
-
- Technical release
- Market release
- Delegation rules
-
Learning Objectives
- Understand the core requirements and responsibilities of the RP
- Complete a final assessment and receive a certificate of completion
Audience
- Employees seeking an introductory overview of the RP’s role and regulatory responsibilities
Features
- Interactive exercises
- Self-paced learning
- Accessible directly from your workplace
- Ideal as an initial, refresher, or supplemental training
- Certificate upon completion
Industries
- Pharmaceutical industry
- Contract manufacturers
- Contract laboratories
- Pharmaceutical wholesalers
Wissenswertes
Individual solution
This e-learning module can also be customized by our learning engineer team for your company with your internal information (e.g. contact details), content (e.g. organizational charts, schedules, forms, leaflets) and your corporate identity. Feel free to contact us!
Lizenz
Single license with a 365 day term.
e-Learning: Responsible Person | FvP Fachtechnisch verantwortliche Person
