We offer a choice of white papers based on our concepts. Please choose the white paper in the dropdown list and enter your contact data in the “Order Download” form. We will send it to you as soon as possible by e-mail. Thanks for your interest!
- Interim Leadership & Project Management: We first understand your situation and then develop a concept. Due to our comprehensive, diversified experience we are in the position to produce practical concepts, reliable project plans and cost estimates within short time. Our project organization is transparent, goal orientated, effective, and tailored to your needs and expectations.
- Operational Excellence: The basic principle of our approach to operational excellence is to identify the overall target of the operational excellence first, then to define the KPIs that support it best, to make things measurable, to assign responsibility, measure results, give feedback, reward achievement, request improvement, keep it simple, transparent and practical. There are 6 operational excellence practices in this concept that should be implemented.
- Strategy & Turnaround: Our approach is completely goal orientated. The target of the turnaround is clearly and measurably defined, and from there the targets for all employees down the hierarchy pyramid developed step by step until all have clear targets that fully support the overall goal. Operational excellence practices (targeted continuous improvement) are implemented in parallel.
- cGMP / FDA Readiness Concept: First we produce a scalable remediation plan with a resource and cost estimate based on a gap analysis of your company. The remediation project, based on your internal expert’s decisions, will be implemented by external experts. A well-tried and standardized process management with templates assures the most effective and transparent project execution.
- Transport Validation / GDP: Usually transport validation projects encompass a complex matrix of few to few thousands of products, hundreds of destinations, several transport categories (e.g. 2-8°C, 15-25°C, 2-25°C) and road, sea and air transports. MVLSC analyzes the data and produces a concept with few clusters that can be qualified in 5 – 30 validations.
- Process Validation: Often validation projects involve re-validations of many older products that need to be upgraded to todays standard and few new products that need to be prepared for launch. MVLSC assesses the situation, produces the concept (e.g. Master Validation Plan, Guideline etc.) and a scalable project plan. Then it sets up the validation team and helps with the first validations in order to train the internal team on best practices.
- Cleaning Validation: Often cleaning validation projects deal with a complex environment of many products being produced in many equipment units. The complexity often leads to laborious validation projects, and a laborious or even non-compliant cleaning approach. Through its experience MVLSC is able to realize significant efficiency gains and develop a simple, robust, practical, and cGMP compliant concept.