Prof. Dr. Florian Priese

Your expert for pharmaceutical manufacturing and quality management cGMP-solutions

You need support with process analysis and process optimization to increase efficiency and quality in GMP-production, with CAPEX-projects realization, technology transfer, internal and external audits or quality assurance and quality management?

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MY COMPETENCES

Process analysis and optimization

Lean / SixSigma, certified Black / Green Belt and Lean Leader

Certified Green and Black Belt, Lean Leader
Profound knowledge of lean methods (SMED, TPM, TQM, value stream mapping, Kaizen)
Deep statistics knowledge for process analysis
Certified KATA Coach

Root Cause Investigation expert

Certified Deviation Investigator

Expert in investigation methods depending on complexity (5 Why, know – don’t know assumption, Ishikawa, contradiction matrix)
Taskforce lead for investigations, use of static methods for data analysis

Head of Manufacturing according AMWHV

Many years of experience as Head of Manufacturing

Responsibility according to AMWHV §12 und 13 for solid and liquid (aseptic) forms, medicine products
Batch release, analysis and optimization of manufacturing processes (validation, and qualification; Batch Record Review) according current GMP-standards

Quality Management

Many years audit experience as audit host and subject matter expert operations

Above 10 years experience in Quality management within the pharmaceutical and medical device industry
Audit preparation and host for national and international authorities (e.g. FDA, ANVISA) and customers
External / interim quality management for risk management, complaints, internal and external audits, change control or CAPA management
GAP analysis for evaluation of regulatory compliance

Senior Project Manager

Successful implementation of CAPEX and technology transfer projects

Training in change management training and project leader (Lead at the Frontline certification, MS-Project expert)
Project Lead/ Analysis and support of internal project manager
Stakeholder-Management (establish status report for senior management)
All project phases from specification, implementation and ramp up

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Cooperation