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–Expert in regulatory compliance audits, remediation plans development and implementation, templates for and development, execution, data analysis, and final report development of ES/COMM./IQ/OQ/PQ/PkV protocols for facilities/utilities, equipment, and computer systems (GxP and 21 CFR Part 11 regulations)

–Experienced in development and revision of standard operational procedures (SOPs) and Validation Master Plans

–Have leading edge knowledge in biomaterials, material surface treatment, tribology, colloids, cutting tools, membranes, powders, gels, fluid pumping and processing, aseptic filling, lyophilization, sterilization and packaging

–Have developed proprietary models/templates for due diligence of regulatory compliance and operational excellence comprising systems of quality, facility and equipment, materials, production, packaging and labeling, laboratory controls as well as intellectual property, product’s commercialization phases, cost of quality, performance and productivity, manufacturing plants, and business entities

–Have thorough know-how in process analytical technology, quality by design, quality function deployment, design controls, system/component impact assessment, critical process parameters, critical quality attributes, deviation investigation, corrective action and preventative action (CAPAs), quality risk assessment, quality risk management, PMA, 510K and IDE, modeling, statistics, Six Sigma and Baldrige performance, lean manufacturing quality and productivity tools

–Have completed successfully numerous regulatory compliance projects for Abbott Laboratories, Becton Dickinson, Eli Lilly, Purdue Fredricks Laboratories, B. Braun, Schering Plough and many smaller size companies

Led the packaging validation group of medium size NJ pharmaceutical company comprising three equipment validation engineers for the validation of packaging processes for over 200 current and new liquid, ointment, cream, aerosol and tablet pharmaceutical products.

Led consulting teams and completed GAP analysis, remediation plans implementation, IQ/OQ/PQ protocol generation, execution, data analysis, and final report preparation projects for facilities/utilities, equipment, and computer systems (GxP and 21 CFR Part 11 regulations.)

Costas B. Chantzis, pharmaceutical, medical device, biotechnology, life science, healthcare, industrial goods markets consultant, expert. He has had an impressive and verifiable list of industrial accomplishments for 27 years in business / operational excellence, Six Sigma, Baldrige business transformation, continuous process improvement, re-engineering, turnaround, validation, regulatory compliance, intellectual property and business due diligence, research and development, technology transfer, process/system improvement and remediation, models/templates for due diligence of regulatory compliance and operational excellence comprising systems of quality, facility and equipment, materials, production, packaging and labeling, laboratory controls as well as intellectual property, product’s commercialization phases, cost of quality, performance and productivity, manufacturing plants, and business entities, biomaterials, material surface treatment, tribology, colloids, cutting tools, membranes, powders, gels, fluid pumping and processing, aseptic filling, lyophilization, sterilization and packaging, process analytical technology, quality by design, quality function deployment, design controls, system/component impact assessment, critical process parameters, critical quality attributes, deviation investigation, corrective action and preventative action (CAPAs), quality risk assessment, quality risk management, PMA, 510K and IDE, modeling, statistics, Six Sigma and Baldrige performance, lean manufacturing quality and productivity tools with an impressive and verifiable list of accomplishments in pharmaceuticals, medical devices, biotechnology, life science, healthcare and other industrial sectorprojects. Feel free to download our company's brochure.

Summary - Continuous Process Improvement, Change Management, Operational Excellence:

–Twenty-seven years of experience in business / operational excellence, Six Sigma, Baldrige business transformation, continuous process improvement, re-engineering, turnaround, validation, regulatory compliance, intellectual property and business due diligence, research and development, technology transfer, process/system improvement and remediation with an impressive and verifiable list of accomplishments in pharmaceuticals, medical devices, biotechnology, life science, healthcare and other industrial sectors

–Have helped such companies as Eli Lilly, Purdue Fredricks Laboratories, Johnson & Johnson, Schering-Plough, Sharp (Pharma. Contract Manufacturer), B. Braun, Alcoa, Minolta, B. F. Goodrich, Kimberly Clark, Abbott Laboratories, Medtronic, Cardinal, and numerous start-up ventures realize millions of dollars in quantifiable benefits

Details:

Reduced equipment qualification protocol variance occurrence rate to 13%. Achieved 75% first pass regulatory compliance approval rate for protocol variance reports.
Developed Periodic Quality Evaluation documents for lyophilization, autoclaving, washing, depyrogenating, aseptic liquid filling and packaging, air handling/conditioning (including environmental monitoring), laminar hood, tank, clean-in-place (CIP), sterilize-in-place (SIP) and sterile water treatment processes of a Fortune 50 pharmaceutical company.
Completed documentation and product quality audits about the state of control of about 100 manufacturing equipment and processes for over 3,000 products at 1,000 employee healthcare manufacturing facility. Assembled documented evidence that supported the continued use of manufacturing equipment and processes until validation activities were completed. Documentation audit comprised the assessment and remediation of over 2,000 SOPs. Product quality audit comprised the assessment of quality control, nonconformance, process yield and product incident report (complaint) data for the last 12 months.
Established template for correctly determining the criticality of over 3,000 medical products and reclassified their performance characteristics. Established template for and completed the development of 35 analytical, material and product test methods.
Brought medical device manufacturer into FDA compliance, reduced by 35% all required documents for manufacture, management and control of the related products and, significantly improved the quality of collected data.
Developed Cost of Quality, Performance and Productivity models for the identification, correction and prevention of related business inefficiencies in any company comprising 44 quantitative metrics.
Developed a simple but powerful due diligence intellectual property model for continuous screening and quantitative evaluation of new products throughout their commercialization cycle.
Invented methodology for quantification of adhesion force of a teflon coating film onto a stainless steel, cardiovascular catheter product. Assisted company gain product release to Japan, $100 million business opportunity. Refocused the technical efforts of biomedical start-up venture for a new, fiberoptic sensor product line. Business potential at $350 million.
Helped medical manufacturer modify its new product design so it could get around specific patent claims. Consulted company for completion of stability, accelerated aging/stress evaluations and 510K submission to FDA.
Helped heart valve manufacturer resolve new product design and cost overrun problems. Recommended surface treatment technologies for improved biocompatibility of fabric, other product components and suggested product manufacturing strategy.
Helped transdermal drug manufacturer identify technologies and develop manufacturing process for new product. Accelerated project schedule by seven months. Projected $12 million sales for first year.
Assisted client estimate the manufacturing cost of new drug delivery product and recommended commercialization strategies.
Completed technical and marketing assessments for antimicrobial technology and intravenous catheter product invention. Recommended technology transfer, alliance and overall commercialization strategies.
Completed market research and identified the size, type and growth trends of worldwide application opportunities for a hydrogel specialty chemical material. Established the top ten market opportunities and estimated the annual resources that each of the top twenty participating organizations had been allocating for the past ten years.
Completed due diligence of start-up medical device company for venture capital firm. Identified strengths and weaknesses of both intellectual and human resource properties. Compiled report with findings and made specific recommendations for resolving a number of technical and marketing issues.
Assisted client in developing overall business plan for a recently acquired business. Resulted in revision of existing mission, objectives and strategies. Led to the application of existing technologies in another market segment, $7.5 million business opportunity.
Assisted major diagnostic kits manufacturer with $3.1 billion in annual sales to complete re-validation of numerous marketed products that did not meet minimal FDA requirements. Activities included design controls, risk assessment, remediation, product and process characterization, protocols for and review of test method and process validation; equipment installation and operational qualification. Manufacturing processes involved various solutions, mixing, lyophilization cycle, filtration, pumping and aseptic filling, process hold time and sonic welding operations for hepatitis, retrovirus, cardiovascular disease, cancer, thyroid disorders, fertility, drug monitoring, congenital and respiratory related test products.
Turned-around the profitability of an electro-mechanical equipment manufacturer, having a 40 people business unit with $3.2 million annual sales but zero net profit. Performed critical evaluation of the strengths and weaknesses of current mfg., engineering and quality control operations and/or depts. Helped in the implementation of own recommendations for the resolution of systemic bottlenecks comprising structure and responsibilities for available resources, manufacturing process flow, quality issues for product components, how to avoid the "fire fighting" approach. Provided alternatives for resolving product design and/or manufacturing defects. Made specific suggestions for improving overall productivity, i.e. how to triple manufacturing capacity while having free resources for new product development. Presented recommendations for the business unit’s regaining of the trust and confidence of their corporate management, sales force and customer concerning their ability to manufacture and market a product line of profitable, high quality medical products. Provided a list of selling-off, acquisition, merge and/or alliance development strategies.
Helped a start-up company manufacturing patented fiber-optic technology catheter products streamline its operations and untap a new market, a $7.5 million opportunity. Streamlined the manufacturing processes and automated a number of critical, labor-intensive operations. Identified and resolved a number of safety and environmental hazards related to chemicals’ ventilation and mfg. site’s soil contamination. Resolved a number of quality product defects related to calibration and stability of electronic hardware; surface treatment and subsequent adhesive bonding of plastic, glass and metallic product component surfaces. Refocused activities of engineering staff and helped them apply proprietary know-how to other technologies for expanding their product line. Helped in the development and implementation of outsourcing strategy for improving net income profitability requirements.
Assisted sutures manufacturer improve by 52% and 15% respectively its quality and cost. The cleaning, siliconization and drying cycles were reduced to two from twenty-four hours. Resulted in $1 million annual savings.
Helped medical device manufacturer eliminate a chronic liquid filling product defect and increase its production rate by 20 fold. Resulted in $300 thousand annual savings.
Assisted plastic bottle closures manufacturer resolve chronic quality defect. Made tooling and equipment modification recommendations, which resulted in the renewing of long-term purchasing contract with previously unhappy, key customer, valued at $3.5 million.
Assisted high-speed color copier equipment manufacturer resolve stubborn contamination problem. Established chemical nature of contaminant and recommended solution alternatives. Annual cost savings at $370 thousand.
Helped diagnostics instrument manufacturer improve by 125% rehydration of multi-component powder reagent. Directed the optimization of both the client’s and its vendors’ manufacturing processes by adjusting granule particle size distribution, bulk density, mixing, concentration and drying of reagent mixture.
Assisted liquid medication manufacturer resolve chronic product defect. Recommended surface treatment technologies for modifying wettability and spreading of utilized liquids and help company improve by 28% product quality. Resulted in $2.5 million annual savings.
Developed outsourcing manufacturing strategy for cardiovascular products manufacturer. Presented advantages and disadvantages of each recommended option and helped in the establishment of new manufacturing plan.
Researched, developed and improved the performance of blood collection test tubes, needles, syringes, blades, lancets, catheters, drains, hemostats, wound healing and closure agents, sterile solutions, drapes, gloves, towels, bacterial filters and associated manufacturing processes; Transferred technology, validated, troubleshot and improved the performance of manufacturing processes in plants throughout the US, Mexico, Puerto Rico and England.
Improved by 32% sharpness of needle for blood gas syringe at manufacturing plant of a sister division. Validated process resulted in timely launch of "Precision Glide" worldwide advertising campaign and turned around politically explosive situation.
Improved by 35% dissolution of lyophilized heparin powder for blood gas syringe. Optimized granule particle size, binders, concentration and freeze-drying parameters. Validated process resulted in timely launch of new product, a $10 million market opportunity.
Improved by 50% quality of blood collection tubes with computer model predicting performance. Established and controlled silica powder’s particle size distribution and agglomeration, the most important process parameter. Validated process resulted in $2 million annual savings.
Identified and satisfied unmet needs of customer by inventing and completing quantitative competitive evaluation of suction catheters and suction canister membranes. Solved airflow restriction and sealing problems, which reversed $500 thousand product back orders. New advertising campaign resulted in $5 million sales gain.
Reduced tubing and adapter costs of molded suction catheter by $175 thousand annually. Validated processes eliminated seventeen-year-old extrusion and molding problems.
Led efforts of two venture groups developing biosensor technology for portable blood gas analyzer. Resulted in small company acquisition with $20 million market opportunity.
Designed and proved feasibility of blood plasma separation tube. Product was developed and marketed with $5 million first year sales.
Invented and developed suction catheter for airway management of critically ill patient. Received design patent. Coordinated market testing of new product.
Developed new package and product performance profile for haemostatic implant agent. Projected annual savings, $1.5 million with FDA efficacy test costs reduced by $225 thousand.
Qualified and validated PVC suction catheter kits for radiation sterilization. Evaluation schedule compressed from twelve months to six. Resulted in $125 thousand annual savings.
Qualified and validated new bottom web for sterile solution tray with high volume form/fill/seal packaging equipment. Helped redesign and build packaging dies in three months.

Speaking Engagements:

35 years experience in Drug/Device quality assurance and regulatory affairs: New product validation and design/transfer including design reviews. Experience leading global quality system software implementation/ validation projects. Extensive FDA/ISO/QSR training, auditing (developed internal and external audit programs) and procedure development. Twenty years experience with customer complaint investigation and resolutions that yielded increased market share. Expert in applying Quality Improvement Principles such as Corrective Action and Preventative Action (CAPA) to a large variety of processes, primarily chemical based, also includes biological, woven / non-woven textiles, stainless steel devices, tablet, capsule, Large Volume Parentals (LVP's), Small Volume Parentals (SVP's), rubber, glass and plastics. Responsible for QA and validation of class 100 environments, Ethylene oxide, Cobalt 60 sterilization processes. Provided strategic leadership for re-engineering and quality improvement that yielded significant competitive advantage. Proven cost cutter, systematic problem preventer, and inspirational people developer/educator.

Speaking Engagements:

John Donohue, pharmaceutical, medical device, biotechnology, life science, healthcare, industrial goods markets consultant, expert. He has had an impressive and verifiable list of industrial accomplishments for 29 years in Analytical Laboratory Test Services for Regulatory Compliance projects. His regulatory compliance record includes:

John Donohue is Director of Laboratory Test Services for TechnoBusiness Solutions. He is well known in the medical device industry since 1978. He has developed several successful methods for predicting the shelf life of products such as the failure or breakage of polymeric delivery systems, the chemical and physical effects of sterilization and radiation, and the dramatic entry of Metallocene Polymers into industry. John has had numerous publications in MDDI magazine, Medical Plastics and Biomaterials magazine, and has been a regular speaker at the ANTEC, Worldwide Metallocene Conference, and the Specialty Polyolefins Conference. One of John's unique abilities is the combined and synergistic use of analytical instrumentation, chemistry, and knowledge of industrial practice to solve material and/or processing problems that disrupt product development and/or production. His favorite machine is a FTIR Microscope and can literally do wonders with it by using it as a powerful secret weapon to uncover root causes to complex industrial material, manufacturing and product problems.

She has sixteen years of industrial experience in all aspects of system level activities with regard to 21 CFR Part 820, ISO 9000, EN 46000, and the Medical Device Directive. Completed projects include 510(k) Submissions, Customer Complaint handling, Corrective and Preventive Action (CAPA) program, Internal Auditing, Supplier/Vendor Auditing, company-wide Training, Advertising and Promotional claims, Product labeling, Regulatory input during FDA and ISO audits. She has developed, implemented, and maintained systems to receive customer complaints systematically and present trend analyses as part of the Management Review process. She has developed, implemented, and maintained the CAPA system that analyzes non-conformances through root-cause analysis. She has re-designed the internal and supplier audit program that is structured around the Quality System Regulation, ISO 9001, EN 46001, and Medical Device Directive. Validated Audit Master database that stores all audit information. Developed and instituted a company-wide training program that encompasses all elements of the Quality System Regulation, GMP, and ISO 9001. Prepared annual company-wide risk assessment for Management which was then implemented into the Annual Quality Plan. Prepared documentation for new and amended 510(k) submissions. Prepared all Regulatory Impact Statements for documentation change order system. Provided regulatory guidance on design and process validations, product labeling claims, advertising and promotional literature, clinical studies. Prepared and maintained Technical File for all product families for ISO and MDD requirements. Assured compliance with Quality System Regulation guidelines by providing technical review for equipment qualifications, process validations, and product performance qualifications. Performed technical review for all Engineering Change orders, MRB (Material Review Board) documents for non-conforming materials, and Continuous Quality Improvement files associated with the complaint handling system. Provided Regulatory guidance to assess product impact. Conducted internal and external audits of quality systems and validation studies to assure compliance with FDA, ISO 9001/EN 46001, and MDD regulations. Extensive experience with FDA and ISO auditors. Validated Audit Master. Audit Master is a data base maintenance system for all audits by which audit checklists, reports, and summaries are developed. Developed the audit program to meet the requirements of the Quality System Regulation guidelines. Participated on several Continuous Quality Improvement Teams. Assured compliance through inspection and maintenance of computer systems, in-house and contract facilities, validation records, personnel training records, SOP libraries, confidential inspection files, shop order control, and traceability. Maintained technical files to assure compliance with the Essential Requirements in the Medical Device Directive. Prepared and assemble documentation (i.e. process flow charts, validation reports, etc.) for PMA and 510(k) submissions. Conducted laboratory and manufacturing facilities audits. Conducted audits of systems and scientific studies to assure compliance with ISO 9002, EPA, and FDA regulations. Created and maintained Sandoz Archives. Supervised Scanner/Microfilm Specialist for the archives. Planned and implemented training seminars. Assembled documents for EPA submissions and state registration of products. Extensive experience with EPA, FDA, and ISO auditors. Provided support for the Vice President of Technology Development and for the Compliance Assurance/Scientific Systems Group. Mrs. Walley has earned a Business Management degree from East Texas State University, Commerce, Texas, completed Clinical Studies for Medical Devices – Center for Professional Advancement, Design Control Training - FDA and RAPS Process Validation Training - Cheryl Boyce, Failure Modes and Effects Analysis (FMEA) Training - Dr. Eden Chen, Taguchi Techniques for Quality Engineering - Philip Ross, GMP Training - GMP Institute, Introduction to GLP and Auditing - International Center for Health and Environmental Education, ISO 9000 Lead Assessor Training - Victoria Group, Crosby Total Quality Training Program, Statistics for Chemists and Biologists - Bill Miller, Toxicology for Non-Toxicologists - Government Institutes, Inc., Establishing Compliance with the Medical Device Directives - Dr. Euan Cameron, BSi; CEEM. In addition, Mrs. Walley is a ASQ Certified Quality Auditor, member of American Society of Quality, and Regulatory Affairs Professional Society (RAPS.) Her industrial affiliations include Inviro, Retractable Technologies, Inc., Mentor and Sandoz.

A molding engineering expert with over forty years of experience in the design of medical, healthcare plastic components and products; layout and design of multi cavity conventional and full-hotrunner molds; and, procurement of injection molding equipment.

A talented CAD, machine shop, packaging and automation professional with over twenty five years of experience.

Our 100% Satisfaction GUARANTEE:

Here’s where the rubber hits the road: If you work with us and for any reason you are not satisfied with our service, we will fully refund your fees (except pre-approved by you project incurred expenses)!

That’s right. We will do everything in our power to help you get where you want to go. We have an excellent track record or we wouldn’t be making you this guarantee, I’m so sure that we can do an extraordinary job for you I GUARANTEE IT! No other consulting company makes you this offer. Contact us today at (908) 387-0447 to get your project started, moving again, done or get your problem permanently resolved.

We will partner with you for your personal and company's success.

I am sure you know that a good consultant can get the job done and a poor selection could make things worse.

Contact us today at 908.387.0447, we look forward to working with you.

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