Consultant Biographies - AQSN - A Quality Services Network

 
     

  AQSN
 A Quality Services Network

World Class Customer Driven Quality

Home Consultant Bios Customer Satifaction Background
 Supplier Management Quality Systems Contact Me 

Consultant Bios

LARRY E. PENNINGTON

 BRIAN DUNCAN

BILL AUER

ED BLESS
GARY ZARO JANE  DILLNER
CARL WOLF DALE THANIG
FRED LAFONTAINE STEVE HANSEN
NIGEL P.C. JOHNSON ROBERTO VALOTTA

     AQSN

              A Quality Services Network

LARRY E. PENNINGTON _______________                                                                                                       

1394 Tularcitos Drive
Milpitas, California 95035

Residence: (408) 263-7235
Business: (510) 579-7890 cell

Larry Pennington is the principal developer and Chief Quality Officer of AQSN, a Quality Services Network, a network of quality professional resources specializing in Quality Systems, Supplier Management, and Customer Satisfaction solutions and implementation.  His primary area of focus is working with clients to provide solutions to their quality systems requirements customized to their bottom line needs through outsourcing of specific functions and programs to reduce costs.  The type of support provided, based on his background of over 30 years of industry experience in quality systems implementation, includes connections to inexpensive web based quality training, customized field support feedback systems, customer satisfaction measurement database reporting over the internet, supplier management through quality requirements and agreements with emphasis on manufacturing outsourcing programs.

Included in his extensive experience, after receiving his BSEE and MSEE from the University of Missouri, Larry provided his services to Xerox-Diablo Systems, Network Computing Devices, Daisy Systems, AG Associates, iLogistics, & Therma-Wave, with the past 15 years at the Director level.  In these senior level positions, he managed various quality, reliability and manufacturing engineering functions.

Prior to creating this AQSN web site, Larry was instrumental in the early creation of “The Quality Network” a quality consulting company which emphasized ISO 9000 implementation.  He also was an independent consultant with Eclipse Group, Inc., a supply chain management consulting firm.

Management Development Training

bulletCourses in: Management Development, Cost of Quality, Cost Reduction, Conducting Effective Meetings, Time Management
 

bulletZenger-Miller - Leadership 2000 Training
 

bulletJcIT - Demand Flow Technology/Business Strategy
 

bulletCost-Effective Supply Chain Management program from NAP
 

bulletSix Sigma Green Belt Course - Sanmina-SCI

Larry has demonstrated improvements in metrics such as board test yields, defective material inventory, out-of-box quality, installation cycle times, product reliability, equipment uptime, and customer satisfaction.  Due to these measures of success, he is directing his efforts in providing these proven methods to upcoming small companies and new growing organizations looking to establish a “World Class Image”, through a “Customer Driven Quality” approach.

BILL AUER

Bill is an operations consultant. He provides expertise for offshore manufacturing management, quality systems and Inventory control. He has guided remote manufacturing companies through new product development and Introduction from Intro to EOL. Bill has utilized ISO9000 criteria as the method of operation for all offshore manufacturing facilities. He has provided factory start-up instruction to factories in Ireland, Japan, Taiwan, China and the United States. Bill has more than 30 years experience in manufacturing operations from Printer Products, Hard disk drives, to Personal Computers. His latest assignment focused on cost reduction and Internet order entry procedures.
Included in his extensive experience, after receiving his BTEE from Oregon Institute of Technology, Bill was responsible for all stages of process test including; functional, download, configure to order and test equipment at OEM Portable Suppliers. He directed the inventory reduction program at the offshore suppliers facility-reducing inventory turns from 52 days to less than 10 savings of $5M annually were realized. He directed the inventory drop ship program, which required no more than a 3,000 DPM DOA level to succeed.

Bill was primary liaison with offshore suppliers for test suite, test specifications, process approval, problem resolution, and management of pre-production ramp schedule performance meeting deadlines and within budget.  Bill managed turnkey supplier early ramp material for lead-time, cost, 2nd sourcing and availability.  He Implemented state of the art innovations at overseas factories streamlining the PC assembly and test process from 24 hours to less than 8.

Bill was responsible for all stages of laptop computer products from definition, supplier selection, development, mass production through obsolescence. Working closely with the design team assessed components for ease of assembly and cost effectiveness increasing productivity and reducing product cost. Bill has completed 8 Portable Products starting in 1992 to the present. He deployed the above Laptop computer products to both OEM and domestic manufacturing facilities. Bill worked with the Portable Product Turnkeys international and domestic suppliers component sources on problem identification and resolution. He combined cross functional teams into a single team including design, materials, supply base managers, service and quality greatly reducing time to market increasing efficiency where by project cycle time was reduced from 18 months to 12 months.
Bill was responsible for directing a QA Department and providing for quality management activities. He implemented modern quality management methods and provided feedback to all levels of management to facilitate change. Responsibilities included Incoming Inspection, Process Audit, Quality Engineering and Reliability Engineering.

At Priam Corporation a manufacturer of state of the art Winchester hard disk drives Bill was Manager of Quality Assurance. Reporting to the Vice President of Operations. Responsible for organizing a QA Department and providing a direction for quality activities. Implemented modern quality management methods and provided feedback to all levels of management to facilitate change. Responsibilities included Incoming Inspection, Process Audit, Quality Engineering and Reliability Engineering. Implemented Quality training and certification program.

ED BLESS

Problem Solving, Organizational, General Management Professional

Team Based Problem Solver, General Manager, AQSN Business Process Improvement Manager for Costs, Profit, Customer Satisfaction, Cash flow from Renewable Energy Alternatives, On-time Delivery, Quality, Reliability.

Summary

 

bulletOrganizational leader with 5 years senior level experience and 20 years of business management experience.  Proven track record of data driven performance and achievement.

 

bulletSkilled in start-ups, business development, people management and planning.

 

bulletProactive leader who builds corporate excellence through a sustained focus on total process engineering

 

bulletTeam player, coach and senior manager, focused on leadership, vision, mission and goal deployment via strategic planning, teamwork, training, process efficiency and integrated information technology

 

bulletDrives increased customer satisfaction resulting in growing market share

 

bulletStrong focus on ROI, high volume cost effective manufacturing, activity based budgeting and organizational excellence

Performance Record

 

bulletHead of H2 Solutions Inc.  Leads with integrity

 

bulletPrevious VP of Manufacturing Technology, GM, COO, Engineering Director.

 

bulletLed multi-$M & multi-$B OEM product operations. Achieved 6-fold increase in profitability.

 

bulletStrong international supply base management expertise, driving highly competitive stakes for reliability, on-time delivery, business excellence, employee involvement and customer satisfaction

 

bulletProficient manager in the engineering, release, production and service operations of leading edge electro-mechanical, renewable energy, semiconductor, computer and robotics equipment

 

bulletLecturer in engineering release process, manufacturing, company re-engineering methods and continuous business process enhancement

 

bulletPrevious director, manager, VP and/or leader for Philips Corp., Tandem Computers (now HP), Apple Computer, Xerox, Electroglas and Asyst Technologies

 

bulletFounder and/or co-founder of 4 separate businesses

Education

 

bulletGraduate course in engineering management, Santa Clara University

 

bulletBS, Science and Engineering, Oregon State University

 

bulletElectronics Technology certified: U.S. Navy

 

bulletGraduate: Crosby Quality College - Executive Level

 

bulletISO 9000 Certified Internal Auditor, Alamo Learning Systems

 

bulletCertified Assessor:  European Federation Quality Management Excellence Model, Frits Institut

 

 

 NIGEL P.C. JOHNSON

http://www.reclipsegroup.com

Business Chain Solutions

nigel@reclipsegroup.com

Principal and Founder of Reclipse Group. A Management Consulting Company

Key Skill Area:  Change Management and Business Operations

Executive Summary:

An “end to end” strategic and tactical Supply Chain expert, embracing the notion of pragmatic “customer driven” holistic, business solutions with enabling supportive information system technologies. A talented team builder and a true believer in the critical role of continued learning and application of knowledge with a passionate and pragmatic “Vision to Action” approach applied to help customers, partners and employees. Very customer driven, supplier sensitive and drives for lowest total cost solutions best customer satisfaction solutions for Reclipse clients.

Special Areas of Expertise:

 

bulletStrategic Supply/Demand Chain Management  

bulletBusiness Solutions with supportive IT Technologies  

bulletGlobal Implementation of Outsource or Insource solutions  

bulletLeadership, Management Coaching and Change Management

Recent Assignment Examples:

 

bulletHW Systems and Operations /NPI Interim VP  

bulletStrategist business re-engineering advisor for a large metals company  

bulletBusiness strategy for a Global Software company  

bulletBusiness development for a Supply Chain Visibility Logistics company;  

bulletGlobal Design and Implementation of an Outsource Supply Chain Operation for a storage area networks company.

Experience: 

Previously, Founder and Chief Executive Officer of Eclipse Group Inc. (founded in 1994), a pragmatic end-to-end supply chain and global logistics professional services entity, headquartered in Silicon Valley, California.  Eclipse held a constant place within the Top 50 fastest growing private companies in Silicon Valley and was the fastest growing professional services Company. Customers included Acer, Apple, Alcoa, Banta, BAX, DHL, Intuit, KLA, Phillips Medical, Tumbleweed as a sample set.

Business Successes:

 

bulletThe original build to customer order (BTO) process for Diablo Systems in 1982 plus the design and implementation of a multimillion dollar “factory of the future”  

bulletHelping to create and grow the supply chain concept, he is credited with coining the phrases “Integrated Supply Chain” and “ Business Chain Management”  

bulletGlobal implementation of the “slip sheet” global material handling technique and information systems as a first in the electronics industry  

bulletLeading the successful operations turnarounds for a publicly traded direct response/ catalog reseller and a retail/catalog/internet computer reseller.  

bulletChampioned the creation of  “channel assembly” as a first for the reseller channel  

bulletMultiple 3PL / 4PL / EMS Global outsourcing implementations  

bulletDeveloped or improved many companies Global Business Models playing key “Senior Executive” leadership roles, to lead, coach or influence organizational and business change success

Education:

Educated in the UK, he served a 5-year technical apprenticeship with Wiggin Alloys (INCO) and earned a Higher National Diploma in Mechanical/Industrial Engineering and Information Systems. He earned a Management Services Diploma after 4 years of additional study.

Trained and mentored by some of the best thought and action leaders throughout his 30-year career with companies that include INCO, Rank Xerox, Diablo Systems (XEROX), Gavilan Computers, Visidata Corporation, Daisy Systems, Apple Computer, Inmac Corporation (now CDW), Eclipse Group Inc., Brocade Communications.

Affiliations & Certifications:

 

bulletMember of the Council of Logistics Management (now Council of Supply Chain Management Professions - CSCMP) bullet

bulletMember of the Association of Strategic Planning  

bulletMember of Institute of Logistics and Transportation  

bulletHas been a speaker at professional and at “what’s next” business chain creator events

BRIAN DUNCAN

Brian has over 18 year Years experience implementing ISO 9000 Quality systems and has held senior management positions with Silicon Valley Companies including Apple Computer, Acer America, Dysan, Velo Bind and Fairchild Semiconductor. He has implemented Quality programs for a broad range of High Tech products manufactured in Silicon Valley, the Far East and Europe.

As the Director of Quality for Apple Computer, Brian was responsible for worldwide Quality and established Quality programs at Apple manufacturing sites in Dallas, Ireland, Singapore, Ireland and Cupertino.

At Acer America, Brian was responsible for corporate Quality during which approx 60,000 computers a month were manufactured. He coordinated the ISO 9000 registration of Acer America in 1992 with 2000 employees. Acer America was one of the first companies to achieve registration in Silicon Valley.

Brian is a founder of Silicon Valley Quality Associates which offers a consulting service to companies who are preparing for registration to ISO standards which include ISO 9001, ISO 13485, ISO 14001, AS9100.

 

JANE DILLNER, C.P.M.

 Executive Summary:

18+ years experience as a profit driven, business/functional Supply Chain Professional/Practioner with extensive global experience in “total cost of ownership” concepts supporting cost reduction and increased process efficiency.  Utilizes well-honed analytical and communication skills with a talent for leading diverse cross functional teams in fast paced, challenging environments to streamline processes, accelerate efficiencies, reduce costs, and improve product quality.  Supply chain career track record includes customer focus, supplier management, sourcing-global and domestic, outsourcing, procurement, strategic contracts, and materials.

 Industries:

 

bulletSemiconductor

 

bulletSemiconductor Equipment

 

bulletContract Manufacturing

 

bulletMedical Equipment

 

bulletHigh Technology

 

bulletElectronics

 

bulletComputer

 

bulletTelecommunications-wireless

 

bulletRetail/Consumer

 

bulletSoftware         

 Education & Training:

MBA University of Phoenix San Jose, CA

BSBA, Major: Business Admin.

 Roosevelt University Chicago, IL
Certified Purchasing Mgr (CPM) Institute of Supply Mgmt Tempe, AZ

 Affiliations:

 

bulletPresident, ISM-Silicon Valley, San Jose, California

 

bulletMember, Silicon Valley Women in Business, San Jose, California

 

bulletMember, San Jose Chamber of Commerce

 Special Areas of Expertise:

 

bulletGlobal/Domestic Sourcing and Procurement

 

bulletVendor Auditing, Analysis/Selection

 

bulletContract Negotiations/Mgmt

 

bulletSupplier Scorecards

 

bulletOutsourcing – OEM and EMS

 

bulletMRO Value Programs

 

bulletP-Card Process Tools

 

bulletReverse Auction Tools

 

bulletProgram Management

 

bulletISO 9000/9001

 

bulletInventory/Cash Management

 

bulletMaterial Evaluation

GARY ZARO

Gary Zaro is a Quality Manager/Engineering Director with 30 years experience in quality and reliability engineering in production and new product development in diverse environments, including 16 years of Medical Device experience at Guidant Corp.  He has an MS-Physics from San Jose State University, and is an ASQ Certified Quality Manager and Certified Quality Engineer. 

As Quality Manager for Guidant Endovascular Solutions, Gary managed numerous quality programs, including evaluation of peripheral, carotid, neurological stent and embolic protection systems requiring CE Mark and Food & Drug Administration 510K approval and Investigation Exemption (IDE) submissions.  He managed review and approval of new product development process validation and approved project risk analyses. 

As Principal Quality Engineer for Guidant Endovascular, Gary completed a peripheral stent system project from concept phase to market release; he wrote the project risk analysis, quality plan, test methods, and filed test reports and protocols. 

Earlier, as Engineering Director for Guidant Vascular Intervention, Gary managed evaluation of coronary stent systems requiring FDA Pre-Market Approval and Investigational Exemption (IDE) submissions.  As Reliability Department head for Guidant Vascular Intervention, Gary managed evaluation of balloon dilatation catheters, guide wires, and accessories requiring FDA Pre-Market Approval (PMA), Investigational Device Exemption (IDE) and 510k submissions. 

Gary’s earliest experience was in regulatory compliance, quality engineering and reliability engineering with Victor Technologies, Xerox, Acurex and Westinghouse Corp. 

Most recently, Gary has been consulting in quality program management.  Recent assignments included completing quality system corrective actions to close out audit action items and processing and investigating complaints for CryoVascular Systems.

CARL WOLF

Carl's expertise is in the development, implementation, and management of hardware test, quality control, and reliability-related programs. Throughout his 30-year career, Carl has spent much of his time working with Asian-based vendors.  For the past 16 years, Carl has worked for Apple
Computer, based in California.  In addition to working at Apple, Carl has also worked for Sun Microsystems, Daisy Systems, Corvus Systems, and Xerox.
Carl has received BS and MBA degrees.

Carl has performed and managed audits throughout the product design and build process including: manufacturing process, quality control, hardware test, reliability, field service, and repair depots.  The majority of the audits were external to the Company, requiring extensive travel.

Reporting to the Director of Reliability Engineering, Carl developed a core reliability and continuation engineering team, responsible for the entire product life cycle of Apple's Imaging Division products (printers, scanners, and monitors).  Carl provided the impetus to use the better suited Bellcore data and process for reliability predictions, and developed several statistical tools to assist the internal prediction process.

Carl developed and implemented a design margin test process, and a fundamentally different MTBF strategy that substantially reduced the amount of hardware and time required to quality product, and simultaneously improved product robustness and customer satisfaction.  He developed a comprehensive test cross-functional plan and schedule, including all hardware and software activity, and has driven and tracked the completion of the tasks.

Carl was the cross-functional test leader and manager for all of Apple Computer products.  Working with a team of 50 engineers, Carl provided a focal point to track and drive all hardware and software test activity, and corrective action, worldwide.  Further, working with the field service organization, Carl used his expertise in formalizing the warranty prediction and spare parts depot inventory control process.

Carl was the reliability focal point for an entire portable computer division, which accounted for $2.5 billion in revenue.  Within that division, Carl developed the reliability and testing paradigm for the entire product life cycle, developed test specifications, negotiated and coordinated test activity responsibilities.  Carl implemented various reliability programs within the company, strategic manufacturing partners, third-party testing facilities, and vendors worldwide.  Using this leveraged testing approach, Carl streamlined the hardware design and test activities,
and saved the company millions of dollars per year.  The reliability of the portable products improved substantially, with the annualized failure rate dropping from 45% to 9% per year.

Carl lives in Bangkok, Thailand, and is available to travel worldwide.

FRED LAFONTAINE

Sentient Consulting Inc.

Global Supply Chain and Project Management, Six Sigma Implementations and Training, 

Business Reengineering

Consulting for 15 years, Fred has excelled at re-engineering business and supply chain processes and concurrent information systems through cross-functional teams. Focused principally on the global Supply Chain, his approach to the project management phase has saved over $300 Mil. for companies mainly in biotech, high tech and regulated industries.  His team approach uses Six Sigma, change management and empowerment tools at all levels. Fred has 30 years experience establishing and managing- global manufacturing, contract manufacturers, supply chains, and Quality and Materials organizations. Fred is a pioneer in establishing international facilities.

  
Consulting Achievements:

 

bulletFitting Image – Supply Chain and project mgmt for a dental and medical design company using global contract manufacturing. Developed the project plan and managed the Asian sourcing effort for the CEO.  

bulletAir New Zealand – Reengineered the supply chain for the maintenance function and materials operations focusing on outsourcing.  Redesigned operations methodology in payload, fueling and crewing using 6 internal cross-functional teams.  

bulletKaiser Permanente – Redesigned the business and financial processes of $1 B in IT assets from planning to disposal using 5 internal cross-functional teams.Pacific Bell – Reengineered the processes from product development and sales through operations and support in the Call Management and IRV business ($30MM).  

bulletSun Microsystems – Developed and implemented a new process of Supply Chain management for global purchasing and qualification of externally purchased products.  

bulletInhale Therapeutics – Restructured purchasing and materials processes to meet cGMP requirements using a team approach. Key member leading team installing JD Edwards (JDE) MRP module including project manpower, capital, and expense tracking.  

bulletCompaq– Program manager supporting 10 teams, developed project plan, schedules, timelines, milestones for the re-engineering of 5 supplier owned centers into three Compaq controlled international product centers; project manager for SAP and JDE implementation.


Corporate Achievements:

 

bulletNektar Therapeutics – Managed purchasing and Supply Chain for pharmaceuticals and devices. Managed costs and authorized payments- of global contract manufacturers;  $45 Mil for facilities construction, tooling and assembly vendors. Saved $2 Mil in European exchange rates. Restructured contracts in materials and services including software support saving $10 Mil. Completed two mock FDA audits and two ISO 9000 audits.  

bulletToshiba America – Managed quality and service for a $1Billion CD-ROM, floppy and hard disk division, including 4 manufacturing sites. Deployed a division-wide TQM and Quality Circle process. P&L and service strategy responsibility for service and configuration centers.  

bulletWyse Technology – Provided corporate direction and management for Asian facilities (3500 people). Developed Asian based manufacturing servicing global demand from $10 M to $1Billion. Managed the global Quality, Materials and Finance functions.  

bulletWestern Digital – Developed and imbedded the Six Sigma process throughout company of 10,000 at five sites. Overall governance of 80 cross-functional, self-directed teams in manufacturing, design and corporate functions saving over $100 Million.  

bulletKalok– Managed global contract manufacturers and materials and purchasing area into an effective supply chain. Restructured global vendor sourcing saving $10 million.  

bulletPfizer – Founded and managed a US plastics molding facility; and a Puerto Rican facility. Member of Warner Lambert’s and the industry-wide committee charged with responding to FDA initial Device Regulations developing cost and timing of compliance; member of the WL internal FDA audit response team.

Fred holds a M.S.in Management Science and Engineering from the Worcester Polytechnic Institute; a B.S. in Chemical Engineering, Plastics Specialty, from the University of Massachusetts; Certificate in Executive management from University of California.

Trained in Six Sigma methodologies at Motorola, and Quality Circles and Deming methodologies at Toshiba.

In addition to consulting, Fred has served as VP of Operations of Kalok Corporation, VP of Quality, Engineering and Continuous Improvement for Western Digital, VP Service & Quality for Toshiba America, Corporate Director of Quality, Manufacturing and Process Technology for WYSE Technology, Director of Operations for Miniscribe Corp and Director of Purchasing and Supply Chain for Nextar Therapeutics.

Fred completed certification through ASQ as a Six Sigma Black Belt (in Mar 05), completed the Project Management PMP requirements, completed the CCNA certification.

DALE THANIG

Dale has over 20 years of achievements in designing and implementing effective Quality Management Systems in medical device, in-vitro diagnostic and analytical product industries while ensuring compliance with ISO 13485, ISO 9001, FDA and international regulations.  Dale is expert at interpreting and integrating the requirements of standards and regulations into effective Quality Management System procedures, product design, process controls and management practices.

Dale has collaborated with FDA, Notified Bodies, Suppliers and Customers in quality system assessments and improvement projects.  He has extensive experience conducting Quality System Audits, preparing for FDA inspections, FDA 483 and Warning Letter responses, driving CAPA programs, conducting acquisition due diligence/integration, developing Supplier/OEM quality programs and delivering Quality Training.

His employment history includes quality and operations leadership positions with the following firms:

  Location Products/Technologies
Varian Associates Palo Alto, CA Radiotherapy linear accelerators
Nicolet Instruments Madison, WI FTIR Spectrometers, EEG/EMG
Dynatech Labs Chantilly, VA In vitro diagnostics
Datex-Ohmeda Louisville, CO Pulse oximeters, Gas monitors
GE Healthcare Madison, WI Anesthesia machines

He is a regular guest lecturer at Marquette University School of Biomedical Engineering and the Medical College of Wisconsin.

Dale served as a member of the Board of Examiners for the Malcolm Baldrige National Quality Award and has held ASQ certification as a Quality Engineer..  

Prior to his industry experience, Dale served as a commissioned officer on the Navy’s nuclear powered submarines, qualifying as Officer of the Deck and Chief Engineering Officer.

Dale holds a BS in mathematics from Marquette University and has done graduate work in statistics and reliability engineering at the University of Arizona. 

He is currently sole-proprietor of a quality consulting firm. Recent clients include ThermoFisher Scientific, VIASYS Healthcare, Byron Medical and TomoTherapy.

STEVE HANSEN

Steve has 21 years of experience in FDA/EU/GMP/GLP regulated industries, 14 years at the manager/director level in pharmaceuticals and 5 years consulting for medical devices. He provides Quality Assurance/Compliance consulting services and customer problem-solving to medical-product and related industries:

 

bulletPharmaceuticals/biotechnology (21 CFR 211/EU Directives)  

bulletMedical devices (Quality Systems Regulation, 21 CFR 820/ISO)  

bulletNon-clinical testing laboratories (Good Laboratory Practices, 21 CFR 58/OECD)

Steve uses a risk-based, even-handed, professional approach in handling issues. He has a reputation for working effectively under time-line pressure while maintaining customer and compliance requirements.

His background includes quality management and consulting positions:

    Products/Technologies
Genelabs Inc. Redwood City, CA Aseptic proteins, steroids, blood-typing diagnostics

Danforth Biomedical
/ ACT Medical        		 Santa Clara, CA Balloon catheters, sterile (Class III), extruded tubing

ALZA Corporation
/ Johnson & Johnson		 Mountain View, CA    Aseptic injectables, tablets, capsules, trans-dermal patches, combination products (firm-ware controlled), packaging & labeling

DURECT Corp.		 Cupertino, CA      Injectable analgesics, trans-dermals, bulk excipient manufacture, isolator technology, packaging & labeling

Steve offers services in four major functional areas as follows.  Examples of his experience and results are shown:

 Creating New Quality Systems

 

bulletHe has designed, implemented and maintained Quality Systems Regulation (QSR) infrastructure to allow a company to build finished products and to start clinical trials (Class III balloon catheter  

bulletParticipated in development and implementation of a successful ISO 9001 registration (current designation ISO 13485:2007)

Directing and Maintaining Quality Departments

 

bulletDirected a QA Operations group, responsible for GMP/GLP functions: Supplier assessment, quality agreements, product release; line inspections; specifications; raw materials & labeling; batch record review; analytical data and CMC section review; validation of equipment and test methods; deviations & investigations (CAPA); calibration and PM oversight; head of the Quality Assurance Unit (21 CFR 58)

Improving Effectiveness and Efficiency of GMP/GLP Procedures and Processes

 

bulletEstablished Quality Agreement requirements & templates where no prior agreements existed between the company and contract manufacturers and partners  

bulletStreamlined manufacturing batch records: resulting in increased record clarity, defined format ownership and compliance “must-have” requirements; reduced time & effort to create masters  

bulletSuccessfully improved products and processes using quality tools (quality plans, fast-cycle technique, brainstorming investigations/fishbone)

Compliance Auditing and Supplier Assessment

 

bulletDirected the suppler assessment department at medical device and pharmaceutical firms  

bulletExperienced external and internal auditor, e.g. API manufacturers including European sites (EU), contract manufacturers (CMO) & testing laboratories, bulk excipient manufacturers

Steve holds BS degrees in Biological Sciences and in Food Science from the University of California, Davis, CA.

ROBERTO VALOTTA

Roberto Valotta is the principal of Agile Technical Solutions. In this capacity, he is providing leadership for teams involved in all stages of product development.

Roberto founded this company in 2003 with the objective of assisting small and medium size companies in producing quality and reliable products based on solid processes and tangible customer satisfaction. 

Prior to his current role, Roberto, a four year veteran of KLA-Tencor and seven-year of Cisco Systems, repeatedly ensured product excellence for demanding customers. Under his direction, the products’ reliability boosted to an unprecedented level and the field returns reached a historical low with cost savings of about $1 Million/quarter.

He combines strategic and tactical skills enhanced by his technical expertise.

Before joining KLA-Tencor and Cisco, Roberto was responsible for all of Quality at Atari Corporation, and he also held several positions at Olivetti Advanced Technology Center, an R&D facility in Cupertino, developing high class servers and PCs. Among other technological and technical achievements, he brought to production the first Liquid Crystal Display for the first Olivetti Laptop.

Roberto has an M.S. degree in Electronics Engineering from the Polytechnic Institute of Turin, Italy.

Home Page    Background    Customer Satisfaction    Quality Systems    Supplier Management     Consultant Bios     Contact Me!

© 1999 - Larry E. Pennington