Consulting services are offered globally in the following areas:

1. Purchasing Controls and Supplier Management (Quality & Development)
   — Are you facing a 483 citation from the FDA for your purchasing controls or supplier management (SCAR) program? Effective purchasing control necessitates the establishment of clear specifications and quality requirements that suppliers, contractors and consultants will meet. Contact me for help with remediation, diagnosis, re-design and implementation of FDA compliant purchasing controls Per QSR, 21 CFR 820.50.
   Essentially, what’s required is:

   1. Establish and maintain procedures to ensure that all purchased or otherwise received product and service conform to specified requirements. Suppliers need not to SELL product to the manufacturer/company to be subject to purchasing controls.
   2. Evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements.
   3. Document the evaluation.
   4. Define the type and extent of the control to be exercised over products, services, suppliers, contractors and consultants based on the result of evaluation. Usually, risk analysis is use to identify higher risk components or services and them more stringent supplier evaluation is applied to suppliers of higher risk components.
   5. Establish and maintain records of acceptable suppliers, contractors and consultant i.e., company shall maintained an Approved Vendor List (AVL).
   6. Establish and maintain data that clearly describes or reference specified requirements, including quality requirements for purchased or otherwise received product and services.
   7. And, finally, include where possible, an agreement that suppliers, contractors, and consultants will notify the manufacturer of changes in the product or service so that manufacture can determine the effect of changes on their finished good or device.

   In summary, there are six phases to implement best practices in order to establish excellent purchasing controls. Each phase requires extensive team work and discussion to successfully move to the next phase.

   • Phase 1 Planning (describe what is to be obtained, identify technical and process information; identify potential suppliers; identify risk(s) and finally identify controls)
   • Phase 2 Selection of Potential Suppliers (Investigate business and operational capability of supplier(s) and select potential supplier(s))
   • Phase 3 Supplier Evaluation & Acceptance (Plan for evaluation and selection criteria; communicate with potential supplier(s) and evaluate supplier(s) ability to fulfill specified requirements; select a final supplier).
   • Phase 4 Finalization of Controls (Establish purchasing information, supplier controls (acceptance activities, verification, etc.)
   • Phase 5 Delivery, Measurement and Monitoring (Receive product/service; perform acceptance activities; conduct measurement and monitoring and analyze data).
   • Phase 6 Feedback and Communication (Feedback and communicate supplier performance, conduct Corrective And Preventive Action (CAPA) process and re-evaluate supplier).

   Working with your team, I will lead an evaluation of your current purchasing controls to assess effectiveness and efficiency, as well as FDA compliance. We can determine the “current state” of your process to establish a baseline, then perform gap analysis, identify pain-points, and develop “future” and “ideal” states for the system. To reach the desired “future” state, a prioritized project plan is created to guide your team. In re-engineering your business process, I utilize lean tools to make it cost effective, user-friendly, and FDA compliant. I can assist with many facets of purchasing controls and supplier management, including: 

   • Development of purchasing control procedures
   • Requirement documentation (specifications and quality agreements)
   • Supplier search techniques
   • Supplier technology assessment
   • Supplier capability assessment
   • Developing qualified supplier registry (Approved Vendor List)
   • Development of quality controls (in-house or at supplier)
   • Root cause analysis of non-conformance
   • SCAR (CAPA) program management
   • Supplier audit program management
   • Supplier qualification and validation
   • Supplier scorecard development

   I can also support your in-house remediation activities and will make recommendations on potential technology or automation upgrades. Lean principles such as Jidoka and Poka-yoke will be incorporated where appropriate.

   Benefits of FDA-compliant supplier management and purchasing control process are:

   • Positive impact on the bottom line
   • Regulatory compliance
   • Risk management & mitigation
   • Operational improvements
2. CAPA (Corrective and Preventive Action) System Management
   — Are you facing a 483 citation for your CAPA system? A well-designed CAPA System can be effective and efficient, as well as compliant with FDA regulation 21 CFR 820.100. Contact me for help with a remediation effort that can lead to an FDA-compliant CAPA program.
   I have sixteen years of experience working in an FDA-regulated industry, and am familiar with GMP, ISO 13485, and the FDA’s Quality System regulations. For a major medical device manufacturer, I led a cross-functional team responsible for delivering an FDA-compliant CAPA program that was fully integrated with the existing ERP system. This effort also included remediation of hundreds of CAPA records. Once the new CAPA policy and procedures were approved for roll out, my team trained hundreds of users using both in-class and web-based instruction. Training records for each employee were appropriately created, digitized and logged within training record files. My efforts resulted in a successful follow-up visit by the FDA, and removal of 483 citations. Additionally, all CAPA records became compliant with the department’s policies and procedures.

   Over the years, I have successfully followed a general six-step approach in initiating, investigating, and closing CAPA cases:

   1. Problem Identification: Document the scope of the issue to be studied, and determine that it is indeed suitable for a CAPA project. Decision trees may be used to facilitate the discussion. Focus on the “inputs” and “triggers” underlying the CAPA request. Accurately describe problem characteristics. Gather evidence of core problems, and document sources of potentially useful information. Evaluate the problem’s impact, considering possible risks to customers and company. Anticipate effects of any remedial action that may be taken. Once the “Who, What, When and Where” of a problem is known, an effective investigation can begin.
   2. Investigation and Analysis: Develop a list of potential problem causes. Consider the data needed to accurately assess the validity of possible causes. Document the procedure by which data will be gathered and analyzed. This could include action objectives, an investigation strategy, assignment of action items, and required resources. Finally, gather all data to be used in problem analysis. Review data to identify the problem’s root cause(s). Focus on similar data points in search of common explanations. Based upon the outcome of the analysis, put forth a proposal for corrective and preventive actions. Statistical techniques are typically helpful in understanding non-conformance and improving efficiencies. These methods may include Statistical Process Control (SPC) charts, Pareto analysis, cause and effect diagrams, 5 Why analysis, change analysis, data trending, linear and non linear regression analysis, experimental design (DOE) and variety of graphical methods (such as histogram, scatter plots etc.) Non-statistical techniques may include management reviews, quality meetings, audits, FMEA, and Fault Tree Analysis. The outcome of this phase leads to an “action plan” that guides the following steps.
   3. Action Development: Investigation and analysis of non-conforming items will result in a list of corrective and/or preventive actions to be undertaken. Task responsibilities are assigned to appropriate resources. Action items are actively tracked to emphasize the need to complete tasks on schedule.
   4. Implementation: Assigned action items are implemented. I typically use an action item log to monitor and control this phase of the project. The CAPA project file is updated with relevant information and/or evidence of implementation.
   5. Verification: Corrective and preventive actions are verified as effective. Progress is recorded in the CAPA case file, and relevant evidence is attached. An independent review is potentially conducted to verify the effectiveness of actions taken.
   6. Closure: As the last phase of the CAPA project, the entire case is reviewed, and evidence of problem resolution is documented.

   My career path has provided me with extensive experience in analyzing, remediating, tracking, escalating, trending and closing CAPA cases to meet or exceed FDA guidelines. While working for a major medical device manufacturer, I also created a CAPA Quality Board to bring “cross-functional unified resolution” to “major” non-conformance as defined by internal quality policies and procedures. I have facilitated CAPA meetings using action, decision, and status logs to effectively document and efficiently communicate outcomes to all stakeholders in a timely manner. While upgrading departmental procedures and Area Work Instructions (AWI), I oversaw the remediation of hundreds of CAPA records. I also worked with the manufacturer’s IT department to develop a “requirement document” and supported the project to modifying the CAPA system. I am trained and have deep-domain expertise in managing and leading program/projects on a global basis.

3. Device Complaint Management Process
   — While compliance with FDA regulation 21 CFR 820.198 is a given for medical device producers, a properly executed complaint management program, integrated into an overall customer-focused approach, can serve to decrease customer maintenance costs, increase revenues, and improve a company’s ability to track historical customer and product trends. Contact me to help you make your process compliant, effective and efficient.
   An effective and FDA-compliant closed-loop solution will analyze the effectiveness of multiple departments, including Call Centers, Sales (Order Management), Warehousing & Shipping, Regulatory, Medical Affairs, Quality/Evaluation & Investigation, Product Development, and Legal. A six-step process generally includes:

   1. Receiving and Capturing Complaints
   2. Complaint Handling
   3. Evaluation and Clinical Analysis
   4. Investigation and Failure Analysis
   5. Regulatory Reporting, and
   6. Internal Quality Reporting and Analytics

   Benefits of a FDA compliant complaint management process are:

   • Positive impact on the bottom line
   • Regulatory compliance
   • Risk management & mitigation
   • Operational improvements
4. Manufacturing/Process Engineering & Tech Transfer
   — If you need intelligent support in either tech transfer or with your manufacturing /process engineering initiatives then contact me for assistance in developing and delivering creative solutions.
   During my twelve years of employment with a leading medical device manufacturer, I participated in a variety of projects related to product development and process engineering. These programs included prototyping medical disposables, developing production line equipment, overseeing the construction of manufacturing facilities, and qualifying production facilities. Many of these projects were conducted on a global basis, requiring that I coordinate and unify the efforts of geographically diverse teams. From a regulatory standpoint, I have authored production specifications and conducted IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Product Qualification) protocols. I have identified, selected, and qualified global suppliers, and transferred unique production methodologies from offshore plants to in-house facilities. When appropriate, I apply lean manufacturing and six-sigma concepts and procedures.

   My career has provided me with extensive training and practical experience in utilizing QbD (Quality by Design) and DFSS (Design for Six Sigma) to optimize the flow of material and information, thereby minimizing rework and waste. Among my many successful production projects are the following two examples:

   • Foresaw the need to create a highly flexible manufacturing platform that would permit the launch of multiple disposable products in diabetes care. I led a multi-disciplinary global team of scientists and engineers to develop and deliver a laser ablation production system (US Patent 6662439). I was responsible for the conception and invention of a novel production process with the ability to ablate 7-15 micrometer traces. Developed in Germany, and later transferred to a US manufacturing facility, this multi-million dollar project resulted in a production system with built-in auto-monitoring and rejection of critical quality parameters. Validated at six-sigma performance, this production line has generated product for a number of years.
   • Led a multi-disciplinary team of US and Japanese engineers and scientists to conceive, prototype and develop a high-speed hot adhesive coating process (desired coating thickness of 30 micrometer). The existing process was slow, wasteful and unable to meet product launch volumes. Incorporating this multi-million dollar equipment into the production flow for a brand-new product required close coordination of raw material suppliers, equipment developers, and manufacturing facilities. Development and qualification of the line was carried out in Nara, Japan, before it was shipped overseas and re-qualified in a US manufacturing plant. Eventually, this equipment transferred to a facility in Ponce, Puerto Rico. Fully automated, with critical quality control checks, the system eliminated post-production inspection activities. It easily met the production volume criteria for launch, and its 25% excess capacity was quickly used to keep up with better-than-expected sales. The on-line inspection system reduced production waste by 80%, and lowered associated inspection labor costs. Again, this production line was qualified at a six-sigma performance level.

   Nearly all of my work has been conducted on an international basis, involving multi-disciplinary teams of colleagues, consultants and suppliers from all corners of the globe. Significant portions of my time have been spent leading or working on projects in Europe (Germany, Switzerland, France, UK, Slovenia, Poland,) Turkey and Asia (Japan, India, Taiwan, S. Korea), as well as throughout the United States and Puerto Rico.

   I utilize “Leanovation” methods in my work, blending Lean and Six Sigma techniques with innovative, creative thinking to deliver superb value during the course of every project. Lean thinking is part of my DNA. To successfully manage programs and projects, I adhere to the following four principles:

   1. Respect: Give due weight to each individual’s concerns. Make every effort to build mutual trust. Proactively resolve conflicts before they can negatively influence the project.
   2. Teamwork: Develop and engage a sense of camaraderie through the vital process of team problem solving. Ensure that colleagues and subordinates see how their activities influence end results.
   3. Understanding: Seeking to understand the nature of a client’s process and requirements. Focus on resolving technical and systemic problems, rather than blaming individuals.
   4. Discovery: The most powerful tool for successful projects is the art of asking questions in a manner that reveals a true understanding of the problem at hand. I am normally quite tactful in my questioning. However, I can also be disarmingly frank when the situation demands a more blunt approach.

   I have been involved with all aspects of program management, including project initiation, planning, execution, monitoring, controlling, and evaluation. Software tools including MindTree, FMEA, Track & Trace, MS Project Management, Decision Log, Action Log, and Minute Management have aided me in successfully managing projects of significant size. I also consider myself a role model and “facilitator” in successfully leading project teams to deliver results.

5. Program/Project Management
   — Do you need a project management expert on your team? Contact me to support and/or manage your program initiatives.
   Over the past eighteen years I have led, and actively participated in, a variety of multi-million dollar global projects/programs covering a wide spectrum of business activities. My experience in manufacturing operations projects has included product design, technology sourcing, equipment development, and plant layout. On the administrative side of the ledger, I have overseen projects related to supply chain improvements, device complaint handling, and a major overhaul of purchasing practices. Nearly all of my work has been conducted on an international basis, involving multi-disciplinary teams of colleagues, consultants and suppliers from all corners of the globe. Significant portions of my time have been spent leading or working on projects in Europe (Germany, Switzerland, France, UK, Slovenia, Poland, Turkey) and Asia (Japan, India, Taiwan, S. Korea), as well as throughout the United States.

   I utilize “Leanovation” methods in my work, blending Lean and Six Sigma techniques with innovative, creative thinking to deliver superb value during the course of every project. Lean thinking is part of my DNA. To successfully manage programs and projects, I adhere to the following four principles:

   1. Respect: Give due weight to each individual’s concerns. Make every effort to build mutual trust. Proactively resolve conflicts before they can negatively influence the project.
   2. Teamwork: Develop and engage a sense of camaraderie through the vital process of team problem solving. Ensure that colleagues and subordinates see how their activities influence end results.
   3. Understanding: Seeking to understand the nature of a client’s process and requirements. Focus on resolving technical and systemic problems, rather than blaming individuals.
   4. Discovery: The most powerful tool for successful projects is the art of asking questions in a manner that reveals a true understanding of the problem at hand. I am normally quite tactful in my questioning. However, I can also be disarmingly frank when the situation demands a more blunt approach.

   I have been involved with all aspects of program management, including project initiation, planning, execution, monitoring, controlling, and evaluation. Software tools including MindTree, FMEA, Track & Trace, MS Project Management, Decision Log, Action Log, and Minute Management have aided me in successfully managing projects of significant size. I also consider myself a role model and “facilitator” in successfully leading project teams to deliver results.

6. Biosensor (Strip) Technology Assessment, Development & Transfer
   — Are you facing design or mass production challenges in your biosensor (strip) product?
   Contact me for cost effective and reliable remedies to typical strip production issues such as: slitting of polyester materials, noble metal adhesion to substrate, coating, reagent dispensing, drying, sealing (heat, PSA, ultrasonic or laser), roll-to-roll assembly, capillary generation, cutting or punching of assembled product, gumming up of blades or dies, build up of static electricity, laser ablation related issues, including moisture or dust control.

   I will diagnose your current process to facilitate a mutually acceptable solution to your strip manufacturing issues. I can also help re-engineer your strip production process utilizing lean tools to make it cost-effective.