Abtract of projects
As a consultant, I generally don't talk about clients. Keywords: Trust and commitment.
But the following selection of projects that we have successfully worked on in the course of our professional activity.
Topic: Selection of suitable packaging systems for the registration (regStab) of pharmaceutical products.
Objective: Creation of a global process involving development locations with different cultural backgrounds.
Realization: Integration of an IT tool, ensuring data integrity, planning tool for storage and retrieval times for different climatic conditions and capacity planning climate cabinets.
Topic: Order planning of clinical test samples (IMP), approx. 1'200 orders p.a.
Objective: Creation of a global planning tool for over 2 locations (USA and Switzerland)
Realization: Development and integration of an IT tool with an integrated workflow system for planning packaging orders for clinical test samples and integration of worldwide shipping to test centers.
Topic: Two existing packaging system leakage
Objective: As fast as possible elimate the issues.
Realization: Elimination of the cause using the ATS method. Set up new manufacturing process development (CtM, CtQ, CtP), statistical evidence, adjust QC plan, documentation according to ISO 13485 Chapter 7.
Topic: Development of a modular packaging system for medical products (Sterile Barrier System)
Objective: Shorten development times, and reduce costs for performance testing and Stability testing (ISO 11607-1:2019).
Realization: Analysis of the worldwide distribution conditions, definition of the worst-case process, development of the modules, construction of prototypes, involvement of the stakeholders for the decision, definition of the worst-case products, testing, integration of the notified body (evidence by document), official change notification, consistent application of ISO 13485 and ISO 14971
Topic: A non ISO 13485 manufacturer outside of the EU creates a procedure & system and packs accord. to MDR Article 22.
Objective: Ensuring compliance with the MDR for market launch in the EU.
Realization: The customer has a QMS according to ISO 9001 - but not according to ISO 13485. Implement extensive regulatory clarifications and a supply chain concept. Establish a quasi-adapted "design control process" and create proof documents of product integrity. (Evidence-by-Document).
Topic: Ensure compliance to ISO 11607.
Objective: Within 30 working days cratioon 20 docuements, e.g. SOPs, WIs, and templates.
Realization: Early stakeholder involvement, application of SIPOC and RACI. Presentation of a holistic concept, get the buy in and create the documents at the same time. the review of the documents was much faster.