Skills and Successes

• Leadership, Organization and Management:  Successfully managed complex teams. Structured organizations for success including plant start-ups, re-organization, closures and transfers. Built and managed strong and effective organizations in multiple situations in the areas of operations, manufacturing, quality, regulatory, engineering, and corporate.
• Regulatory Turnaround:  Successfully completed multiple turnarounds of broken quality systems and FDA relationships.
  
• Quality Systems and Quality Assurance:  Built successful, self-sustaining quality systems including design controls, process validation programs, CAPA, management systems, process controls, documentation systems, supplier controls and others. 
  
• Regulatory Compliance:  Successfully applied practical solutions in compliance with Food and Drug law while enhancing business outcomes.
• Regulatory Affairs:  Implemented regulatory strategies that ensure strategic advantage for organizations including compliance, FDA relationships and submissions.
• Project Management:  Improved systems, cultures, and organizations through project management, continuous improvement, and teamwork. Led projects in multiple situations including crisis management, FDA enforcement and quality systems implementation.  
• Auditing and Assessments:  Audit and conduct gap assessments for upgrading QSR and ISO13485 quality systems.
• Training:  Developed and implemented training and organization development programs related to Quality Systems, QSR, Compliance and CAPA.
• Strategic Planning:  Experience with design, implementation and measurement of strategic plans.  Experience linking improvements of key measures to strategic plans.  Established successful strategic planning systems.
• Diverse Industries:  Significant experience with multiple industries including Medical Devices, In-Vitro Diagnostics, Human Tissue, and Blood testing. 
• Diverse Device Types:  Significant experience with IVDs, complex electromechanical devices, active implantable devices, spinal implants, single use products, LASER products, infusion pumps, ablation catheters, high-volume disposable devices and others.
• Diverse manufacturing locations:  Significant global experience including US, Mexico, China, Thailand, Israel, Korea and many European locations.

Contract Management Positions Held from the period of 2000 to present.

• Vice President, QA/RA, In Vitro Diagnostics
  
• Vice President, Quality, Boston Scientific Neuromodulation. 
• Vice President, Quality/Regulatory; Orthopedic Manufacturer, start-up.
• Director (multi-site), Quality; Boston Scientific
• Director, Quality, midsized infusion pump manufacturer.
• Director, Regulatory Affairs, small infusion pump manufacturer.
• Director, Quality, start-up orthopedic manufacturer.
• Director, Quality Systems, CAPA, NC; major medical device manufacturer.

Summary of Companies Cleared of FDA Warning Letters and Resolved Consent Decree

• Dialysis Electromechanical, Class II/III Devices
• Dialysis Solutions, Class II Devices
  
• Dialysis Disposable Tubing, Class II Devices
  
• High Volume Disposable Tubing, Class II Devices
• Human Tissue Processing
• Infusion Pumps, catheters and disposables, Class II Devices.
• Infusion catheters and disposables, Class II Devices (consent decree)
• Ablation Catheters, Class II and III Devices
• Cutting Balloon Catheters, Class II and III Devices
• Neurostimulators, Class II and III Devices
  
• Infusion Pumps and disposables, Class II Devices
  

Samples of Completed Consulting Projects

FDA Consent Decree of Permanent Injunction

          Client:       Manufacturer of Class II infusion devices and tubing sets.

Problem:    FDA Warning Letter led to Consent Decree, shutting down all product lines.

Solution:    CERICON assisted in editing the Consent Decree from the company’s perspective.  CERICON executed a work plan with company personnel to revalidate all products and processes, and upgrade core Quality System elements. CERICON conducted and delivered to FDA certification audits of the Quality System.

Result:      Within 4 months, after a successful FDA inspection, company's products were back on the market.

FDA Warning Letters

Client:        Major manufacturer of Class III implantable electronic devices.

Problem:    FDA Warning Letters existed with parent company.  Company was sold and the new parent company was under a FDA Corporate Warning Letter.

Solution:    We established a task force approach with several teams resolving the identified issues. We hired personnel to staff QA and regulatory departments. Implemented and redesigned several Quality System elements including CAPA and NC processes.  Also hired many consultant experts to tackle specific issues within the Quality System.  We held short interval management tracking including frequent follow up.

Result:       All known issues were corrected.  The subsequent FDA inspection resulted in no 483 findings.

FDA Warning Letter

Client:       A global provider of electromechanical and high volume single use medical devices.

Problem:    FDA warning letters existed for multiple plants. Consent decree was likely.

Solution:    We established a task force approach with several teams resolving the identified issues in all plants. We hired internal personnel to staff QA and regulatory departments. We held short interval management tracking including frequent follow up. We also held frequent communication meetings with FDA. We allocated funds to cover needed investments.

Results:     All known issues in all plants were corrected. The FDA inspections were successful for all plants and resulted in clearing all open warning letter issues. The client has gained tremendous credibility with the FDA. Operations have been greatly stabilized.

FDA Warning Letter

Client:        A U.S. supplier of a liquid-based non-sterile medical device.

Problem:    The company received two FDA warning letters within two years.

Solution:    We conducted warning letter, QSR and ISO gap assessment with the management team. We trained the management team and developed a project management approach to addressing issues through sub-teams. We held frequent meetings with the FDA to resolve concerns. We allocated funds to cover needed investments. We also designed and developed a strong and sustainable quality system.

Results:     All known issues were corrected. The subsequent FDA inspections were successful and resulted in clearing the open warning letters. The company has achieved ISO certification and the plant has had good compliance results since.

Orthopedics Start Up

Crisis Management

Client:       A global provider of single-use medical devices.

Problem:    The client had a patient safety crisis resulting from defective products.

Solution:    We implemented a crisis management plan. We stopped all nonessential activities and product distribution. We coordinated the press, FDA, other regulatory agencies, and internal resources.  We also led the overall team that coordinated the specific action teams.

Results:     The root cause of the problem was determined and was solved. Production and distribution was reinitiated. The successful result prevented the product line and company from incurring permanent damage. The company is now successfully growing again.

Design Controls

 Client:       A global provider of single-use high volume medical devices.

Problem:    The client's new product design process was inadequate. The company was also out of compliance with FDA and ISO9001 design control requirements. New designs were not being released rapidly.

Solution:    CERICON audited the design controls and defined gaps. We developed and trained the organization in new design control procedures based on FDA guidance documents and customized to meet their needs. We clarified the design planning approach, input documents, output documents, approach to design validation, design verification, design reviews and design history file and wrote validation protocols.

Results:     The design control program is understood by all engineers and is in compliance with FDA and ISO9001 requirements. The client's most recent new product project is progressing on time and on budget and will meet the user needs as originally defined.

Process Validation

Client:        A global provider of single-use medical devices.

Problem:    The client's production processes are not validated.

Solution:    CERICON audited the process validation approach and defined gaps. We developed and trained the organization in a new process validation procedure based on GHTF and FDA guideline documents and customized to their needs. We developed a process validation master plan defining action items and a process validation implementation team. We also wrote process validation protocols and completed validations.

Results:     The client now is in compliance to FDA and ISO process validation guidelines and requirements. Problems were solved in key processes resulting in higher quality, yields and productivity for the product line.

Continuous Improvement Process

Client:       A global supplier of a high technology product serving the process control industry.

Problem:    The company's rate of change and completion of projects were inadequate to keep up with market demands.

Solution:    We defined a continuous improvement process, philosophy and tools. We implemented a team-based improvement approach throughout the company.

Results:     The improvement process is used throughout the company and projects and change initiatives close at a high rate. The company is first in its industry for quality, sales and profitability.

Ineffective Quality System

Client:       A major U.S. blood testing laboratory.

 Problem:   Several elements of the company's quality system were not defined resulting in poor operational efficiency and effectiveness.

Solution:    Cericon conducted a needs assessment with all key personnel. We audited the quality system and identified gaps, created action plans and oversaw implementations. We also created and implemented specific systems including project tracking, management review, document control and training documentation.

Results:     Management is better-informed and making improved decisions through the new management review process.  The implemented changes resulted in significant improvement to the overall operation.