MES: Establishment of an MES application for PIC (Powder in Capsules, tabletting & steriles.

Root cause analysis:

• Deviation, OOS, OOE and complaint handling for products of key customers related to release testing, solution prepa ration, sterile and aspetic filling of vials and ampoules, vi sual inspection, packaging and stability testing.

CAPA, change and project management:

• Supported CAPA implementation, handled changes and performed FMEAs (failure mode effects analysis) for all vial and ampoule lines, implementation of new glass manage ment, optimization of filling lines related to glass breakage prevention, dispersion of glass particles in case of glass breakage events, reduction of glass to glass and metal to glass contact, optimization of setup process for filling and crimping stations, FMEAs for blind spots of semi and fully automated visual inspection (AVI), optimization of AVI and full revalidation incl. Knapp study, optimization of test instructions for HPLC analysis of assay and known and unknown impurities of specific drug products, optimization of production planning and order fulfillment, improvement of plant logistics and WIP (work in process) storage facilities to ensure cold chain for refrigerated products.

Customer & Healthcare Authority Audits:

• Preparation of customer and healthcare authority audits.
• Support during ANVISA, FDA and Russian Heathcare authority audits.

Investigation lead:

• Investigation lead during significant investigation initiatives involving glass and stopper vendors.

Key account management:

• Single point of contact for Merck Sharp and Dohme for all deviation, OOS, OOE, CAPA, complaint, validation, product transfer, regulatory and supply related topics.

Training/ SOPs:

• Improvement of test instructions, creation of new glass breakage procedure, improvement of laboratory organization of IPC and release sample testing and associated SOPs, new SOP for handling of glass breakage events at the vial and ampoule filling lines, training of shopfloor staff how to perform discarding of glass contaminated objects after glass breakage incidents whether witnessed or unwitnessed, training how to apply root cause investigation tools

secundary project

Melsungen for Greenfield project in Rumania

• Creation of Process description for incoming and release testing, plant logistics, weighing & dispensing, solution preparation, filling (blow fill seal technology), visual inspection sterilization and packaging for LVP (large volume parenterals), In- process controlls (IPC).

IT & automation concept:

• Development of automation concept and IT Infrastructure concept, creation of URS, FRA (functional risk assessments) & tender documentation, Workshop preparation and moderation, scheduling & budgeting of activities.   

• Planning and managing of analysis, design, build and deployment phases for Pharma template, Medical Device template and ERP adapter (for SAP ECC).
• Technical guidance on Core documentation (URSs, Validation Master Plan, GxP & ERES Assessments, Functional Risk Assessments, traceability matrix), organisation and moderation of workshops and Steering Committee meetings, development of validation concept, development and establishment of infrastructure concept for global QA, site QA and Productive systems, development and implementtion of harmonization concept for eBR (electronic btach records), MBR design training, establishment of site deployment plans for the production sites in Italy, Poland and Hana (Carribean).

secundary project

• Setup of global Track & Trace project by definiton of core strategy, creation of Track & Trace system description, definition of IT- Infrastructure concept for all B.Braun sites, VMP (validation masterplan), Core Track & Trace URS, Functional Risk Assessment (FRA), URS for local/ site Track & Trace systems, FRA, URS for global SAP Track & Trace system (SAP ATTP), FRA, development of offline print centers for fixed layouts and variable data. 

Preparation of Core Documenation for leveraged commissioning for complex Track & Trace labelling and packaging hard- and software solutions for leading Pharmaceutical companies such as Novartis, Sandoz, Bayer, BMS, Sanofi, Boehringer Ingelheim.

Related Equipment:

• Flight Conveyer, Checkweigher and integrated solutions for item serialization,
• aggregation and dis-aggregation (items to bundle to case to pallet), incl. interfaces to MLS Multiline server, SAP Aii & ATTP, MES (Werum PAS- X).    
• Prepared, updated Configuration Matrices, Functional Specifications, Hardware Design Specifications, Validation Plans, test scenarios for System tests, FAT (factory acceptance test) testpalans, SAT (Site acceptance test) testplans and product updates of core documents for customers such as Parameter setting lists and Traceability matrices.  

Root Cause Analysis:

• Supported software department in moderating root cause analysis to identify cause for data base inconsistencies, for instance time stamp errors, incorrect batch data, verified correct export of batch data from Single Unit to Multi Line Server and export to SAP Aii.

Impact Assessments:

• Conducted Impact Assessments for changes, created installation procedures for software updates and associated test plans.    

UDI implementation:

• Identified and resolved gaps in bespoke packaging and labelling software, implemented neccessary changes due to UDI (Unique Device Identifier) requirements, created Validation Plan, updated URS, conducted FRA, created traceability matrix and required test plans for label creation software part and for label printing at packaging lines, managed IQ/ OQ and PQ with a small team, created cutover plan, trained the plant team and successfully implemented the new GAMP5 category SW version on the shopfloor.

CAPA related activities:

• In parallel implemented nomenclature of product desciptions and arranged CAPA related proper translation of about 10000 items into the 25 languages of the target markets.

• Ensured compliance to the Novartis Quality Manual and Good Manufacturing Practice of all activities related to commissioning and qualification of the New Solids Launch Facility for Novartis PharmOps covering utilities, process equipment (OSD oral solid drug manufacturing/ inhalation drug manufacturing) packaging, Plant Automation, IT Systems, Manufacturing Execution System and laboratory equipment.
• Reviewed engineering documentation such as URSs, Functional Risk Assessments, Qualification Plans, Design documents (drawings, R&ID - process and instrumentation diagrams), Qualification Reports, IQ, OQ & PQ testplans and reports, Validtion plans and protocols to assure accordance with GMP regulations and the Novartis Quality Manual.

Training concept & Delivery:

• Developed training plan and matrix according training needs of different job roles within the project, created standard operating procedure and implemented training at NSLF, mainained scheduling by LMS electronic training system and monitored training performance of all team members. 
• Delivered classroom based GMP, Deviation handling, CAPA handling, Validation and Qualification and Testplan training.

Audit Program:

• Developed and established Self- Inspection program and conducted Self Inspections as the lead auditor to drive continuous im improvements.

Deviation & CAPA handling:

• Established Deviation Handling and CAPA system, conducted Root Cause Analysis and assessed impact of deviations from predetermined acceptance criteria.

Vendor evaluation:

• Managed vendor selection, evaluation and CARs (ANA Audit Need Assessments, Corrective Action Requests)

• Successfully re- organized cleaning, sterilization and compounding section of Novartis Steriles by implementing work stations, 5S; established and executed classroom based and on the job training (OJT) and qualification of personnel in sterilization processes, compounding and filtration, established new layout of cleaning section, developed URSs for new equipment, accomplished various projects to qualify new cleaning and sterilization equipment and optimized loading schemes and recipes for autoclaves.

Quality, regulatory and development related activities:

• Established and implemented Quality Management System for Medical Devices according ISO13485 and cGMP requirements of QSR 820 CFR21 for the US market into already existing structure of the Pharmaceutical organization.
• Created Quality Manual, top level SOPs such as Management Reviews, Design and Development, Internal Quality Audits, CAPA, Post Market Surveillance Activities and Supplier Management- established a supplier selection, evaluation, qualification and effective performance repor- ting system with KPIs, established an effective CAPA process  based on a risk evaluation matrix with adequate root cause analysis tools, CAPA plans and evaluation of effectiveness.

Regulatory and product development activities:

• Support of development activities of the SUREPAL PEN drug delivery device with new drug dosis and associated documentation for 510K and CE- Marking.

• Managed large cross functional team with various suppliers for 510 (k) PMN (premarket notification) filing of a complex CAD/ CAM platform for dental prosthetics such as crowns, copings, implants, supra structures and bridges.
• Conducted gap analysis regarding necessary documentation for successful filing of Medical Device software with FDA “Moderate Level of Concern”, created templates and necessary documents for architectural design, Software Requirement Specifications (SRS), Software Design Specifications (SDS), Conducted risk analysis, planned and conducted verification & validation activities, performed Traceability Analysis and ensured appropriate Configuration and Life Cycle Management.

Update of Quality Management System (QMS):

• Gap analysis of existing QMS, adjustment of various subsystems of organization´s Quality Management System for the new software product not covered by the existing QMS of the company

• Improvement of IVD platform for an IHC immunohisto- chemical assay, review and adoption of existing documentation and successful validation.
• Clinical trail support, regulatory support for market release of combination product “drug/ in- vitro diagnostic” for a new indication (lung cancer NSCLC) of an existing cancer therapeutics.

• Juran Institute, Inc. provides training, certification, and consulting services to organizations, focused on quality management including services such as lean, lean six sigma, benchmarking, problem solving, cost reduction, innovation, quality planning, quality improvement, quality control, Baldrige assessments, and continuous improvement, catering to organizations in healthcare, service providers, manufacturing, finance, automotive, education, government, and oil and gas sector.
• Gap analysis between approach and deployment of company´s business operating system (BOS) e.g for Johnson controls within 160 plants to gain baseline, to identify weaknesses, to develop and implement QIR ( Quality Improvement Roadmap).
• Conducted various audits as a lead auditor in electronic, interior, metal plants to analyze and score the following subsystems:
  • Management
  • Customer Firewalls
  • Product Safety Certification
  • Quality Systems
  • Supplier Quality
  • Corrective Action
  • Problem Solving, 5S/ 6S, Error Proofing
  • Standard Work
  • Kaizen
  • Tooling and Equipment
  • and Engineering Resources to identify areas for improvements, developed and success fully implemented improvement roadmaps.

• Dentronic was trading dental accessories and units and besides that has started to develop and manufacture devices for dental instruments. Conducted gap analysis, set a framework for the QMS, reviewed existing documentation and closed identified gaps within Device Master Files (DMRs) Device History Records (DHFs), created SOP´s, defined Quality policies, Quality management principles and objectives, Quality guidelines for each function and Q- Plans.
• Defined processes for non- conformance and CAPA handling, defined and aligned sales, marketing, procurement, production and supporting processes (order process, personnel management, complaint handling, communications, labelling, storage & dispatch), defined and set in place performance measurement system, process measurement & analysis of quality relevant processes, trained and intro-duced QM system to employees, defined supplier selection criteria, evaluation of suppliers and type and extent of control for incoming material to meet specified requirements.
• ISO 13485 QM System was successfully approved by LRQA, Cologne

New product development of dental device- control system for dental drills and scalers (rotation speed and torqueDesigned project and deliverables:

• Work Breakdown, Gantt Chart, Activity network diagram, critical path, defined and maintained project evalution, resource management and budget.
• Closely worked with R & D departments, head of regulatory affairs, procurement, marketing and international 

  subsidiaries of business partner of a Swiss Dental company and sucessfully developed a device for precisely controlled speed range 20 – 40000 rpm and with 1:5 contra angle up to 200000 rpm, change of rotation, torque control for dental applications such as root canal treatments, cavity preparations, gross caries removal & bone surgery with 4 preselectable speed and power levels and automatic reverse function.

• In 2006 the ADA (American Dental Association) tested performance of dental instruments of the 8 leading manufacturers in the world and theSwiis dentral drill controlled by the Dentronic Device was the only instrument reaching pricesely the target rotation speed of 40k rpm and 200k rpm with 1:5 contra angle.

The product was launched as a package including BienAir MX mirco-motor with Dentronic “Optima T+R” control device in the US market and Europe.  

Developing, implementing and maintaining a Supply Chain Management system:

• According to requirements of Quality Management System and the desire of achieving higher performance by reducing variation in the processes, better utilizing resources and more focussing on value stream reduced number of vendors and to established formal process for collecting, analyzing and reporting supplier performance. Identified and defined external customer´s requirements and needs by customer surveys, focus groups, questionnaires e.g., identified internal customer interfaces, their needs, performed gap- analysis, set improvement objectives & measurements, implemented system for tracking & reporting performance and for continuous improvement, defined and negotiated QLA.
• Communicated product & process requirements, order & delivery requirements and safety & environmental requirements to suppliers, established supplier scorecard with metrics for PPM, accuracy, timeliness, completeness, responsiveness, return of rework, technical support given, supplier performance Cpk and supplier process Ppk to periodically compute numeric score along with total score and category labels.
• Developed certification process to foster relationship with labelled suppliers to reduce inventory with various interim steps ( from ship to stock – JIT) to end up with modular assembly

Continuous Improvement with SIX SIGMA tool box

• To reduce lead time to completion, to improve quality significantly and to optimize the overall performance implemented Six Sigma DMAIC- cycles in all departments of the organization ( sales, marketing, procurement, production, delivery and service). Analyzed processes and sub-processes at all levels and defined areas for improvement
• At a very early stage reduced cycle by eliminating non value added work by simplifying and streamlining processes, reduction of unnecessary complexity, reduced motion, conveyance, overproduction, overprocessing, waiting, inventory, correction and rework.
• Created an "As- Is" and developed a "Should- be" process map, trained and coached staff with process improvement tools for defining, measuring data, analyzing data (e.g. root cause analysis tools, cause & effects diagram, process mapping), tools for improving and control (failure mode effects analysis, Statistic Process Control), identified projects for improvements, built cross- functional teams, defined problems, developed project charter, gathe- red data, validated measurement & measurement system, determined baseline levels, baselined capability and Sigma levels, determined and quantified performance objectives, analyzed data, root causes or key factors for process variation, identified or selected solutions, defined implementation by action plans, communicated solutions to all stakeholders, implemented solutions and monitored improvements versus objectives, replicated and standardized improvements.