Summary:

 –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 

Details:

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. 

• Ensured all consent decree, cGMP Workplan commitments and regulatory compliance initiatives were completed ahead of time and in full compliance with company standards. Completed commitments on time for compliance audit responses and preventative actions on protocol variances. 
• Supervised group towards the completion of over 150 equipment qualifications and packaging validations in support of the Validation Certification Program (VCP), New and Base Business Product Presentations. 
• Drove Continuous Quality Improvement as a mindset. Reduced equipment qualification protocol variance occurrence rate to 13%. Achieved 75% first pass regulatory compliance approval rate for protocol variance reports. 

• Audited existing validation reports and 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. 
• Developed and executed IQ, OQ, PQ and PV protocols/reports for the validation of analytical laboratory instruments, liquid, cream and tablet packaging equipment for contract packaging and drug manufacturing companies. 
• 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 and completed 40 calibration SOPs. 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.
• 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. 
• 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. 
• 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. Help redesign and build packaging dies in three months. 

• Chairman of 3.5 hours Regulatory Compliance and Business Excellence Workshop: Regulatory Compliance and Business Excellence Lessons Learned (Seminar Speaker); Case Studies on How-To Troubleshoot Quickly and Correctly Your Material and/or Process Problems With Analytical Laboratory Expertise/Know-How; Data-Driven Methods for Regulatory Compliance and Business Excellence; Case Study - Improving Manufacturing Performance & Cycle Time at DuPont Pharmaceuticals, Interphex 2007 - April 26, 2007, New York, NY
• Seminar Presenter: Developed and presented 3 hour workshop with subject “Lean Six Sigma for Pharma Manufacturing: Benefits of Compliance” with only 4 hours prior notice and was congratulated by the seminar attendees and Conference Director, July 24 - 26, 2006, Philadelphia, PA 
• Conference Chairman: GMP Requirements, Outsourcing and Manufacturing of Active Pharmaceutical Ingredients. Presented seminar on Technology Transfer Strategies, 26-27 March 2001, New Orleans, LA 
• Conference Chairman: R&D Alliances for Pharmaceutical/Biotechnology: Build Collaborations and Consortiums to Achieve Maximum Commercialization. Presented seminar on Valuation, Contracting and Licensing Agreements, Strategies for Newly Developed Technologies, 23-24 October 2000, Boston, MA 
• Seminar Presenter: Manufacturing Active Pharmaceutical Ingredients (APIs): Effective sourcing and supply chain management of APIs. Cleaning validation for API manufacturing facilities. Critical strategies for API regulatory requirements, validation, outsourcing and technology transfer. Presented seminar on technology transfer strategies, 6-7 December 1999, Atlanta, GA 
• Conference Chairman: Biotechnology and Pharmaceutical Conference: Patents, Licensing, Trademarks and Intellectual Property ’99: Strategies to maximize protection and financial profits. Presented seminar on Intellectual Property Valuation, 28-30 July 1999, San Francisco, CA 
• Seminar Presenter: Business Transformation Through Re-engineering and Continuous Improvement - powerful models and practical strategies for an ever rapidly changing global business environment, 19 May 1999, Princeton, NJ

Summary:

Barry Graziano, is Director of Quality Assurance, Quality Management and Quality Systems for TechnoBusiness Solutions. Barry has 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.

Details:

• Developed and implemented Documentum based Global Quality Standards Electronic Document Management System and website in 6 months. Lead the development teams for 12 Facility and Equipment Global Standards and 35 Quality System Global Standards. Exceeded all historical expectations for development and approval of these standards. Implemented Web-based global training program using WEBEX and INTERCALL that saved $500M in travel costs. 
• Development and implemented a global Quality Document Management System. Including development and rollout 130 global, Quality Standards to pharma and device plants worldwide. Developed/led training workshops for site responsible individuals. Lead standards development team. Developed Standards Rollout Website and online assessment and implementation tracking tool. Developed matrix to ensure New Quality Standards fully comply with CFR 210 and 211, 220, EC and ICH guidelines and regulations. Implementation completed on time. 
• Developed and implemented an internal audit program for World Wide Medical Affairs (WWMA) Clinical Development Program. Lead corrective action for the Audit of the Drug Safety department that reduced late Serious Adverse Event Reporting from 70% to zero late in 3 months. Developed and implemented CMOM mission vision and values workshop to create esprit de corps for newly created department. Implemented WWMA Global glossary on Lotus Notes. Created CMOM Lotus Notes Workspace for intradepartmental communication. Directed development and implementation 30 Global Standard Operating Procedures for WWMA.
• Led implementation of Global Document Management System using Documentum. Develop new strategy for internal audit system that changed focus from static compliance to Improving ROI. Developed new Quality System Workshop and Global Quality Council Strategy. 
• Developed a strategy to transform the Quality Information System and obtained capital-funding approval of $5MM for this project. Selected and led a multi-plant team that developed and implemented an enterprise wide Laboratory Information Management System (LIMS). This is largest systems project in ETHICON’s Quality Assurance history. Cost reduction of $1.2MM, Quality System consistency, increased compliance, transcription error reduction. Validated, nationwide, integrated quality database, which provided key tool for strategy to foster organizational transformation from assessment to prevention mode of operation. 
• Chaired Needle Standards Committee, a team chartered to reengineer Needle Quality System. Developed and implemented revision to corporate defect classification policy that significantly reduced liability to 483 observations and recalls. Needle Quality System revisions and training program saved $1MM in rejects in 1995. Awarded Vice President’s Award for Teamwork in 1995 for this successful effort. 
• Provided QAE support to team that validated and implemented the change of Ethylene Oxide Sterilization from 12/88 EO/Freon to Oxyfume in six months. This team won the Vice President’s Award in 1995.
Supervised team that developed operator certification program that reduced QA headcount by 40% while maintaining quality metrics and compliance. 
• Provided in-process inspection, finished goods inspection/disposition, GMP Audits, quality engineering to the Somerville needle making, Suture Assembly and Sterilization processes (Co60 and ETO).
Initiated a Quality Improvement Process using employee empowerment that reduced by 70% and 60% the finished goods failure rate and process deviation, respectively. Facility recognized as best in Quality Improvement Process in 1991.
• Initiated Good Manufacturing Practices (GMP) Committee to develop and implement GMP education program for the 1200 associate plant work force. Reduced Corporate Regulatory audit observations by 80%. Ethylene Oxide Sterilization audit of July 1991 was the first ever to receive zero observations.
• Pioneered ETHICON’s Quality Career Development Program in 1989. This program refocused associates to other jobs; resulting in a H/C reduction from 90 in 1989 to 40 in 1993, without a layoff. 
• Established a validation committee and teams in 1989. Completed validation of all critical processes within 2 years in response to new FDA requirement.  Only facility that achieve our targeted goals.
• Led plant QA team in program that achieved ISO 9000 certification in 1994. 
• Directed the Quality Assurance Program for Becton Dickinson’s transnational, sterile-pre-filled syringe business. Technologies included: Ethylene Oxide and Cobalt 60 sterilization, glass forming, stainless steel and rubber processing. Responsible for domestic and international regulatory affairs. 
• Trained, audited and assured cGMP in three production facilities located in the US, France and Mexico. Worldwide sales $60MM. 
• Developed Quality Systems, process validation protocols and related training programs for transfer of syringe manufacturing from US to Mexico. 
• Developed and implemented process/facility validation program for new Ethylene Oxide facility in 1987. 
• Revised and streamlined complaint analysis and documentation system.
• Hired to revitalize the quality program of a division that had over $100MM yearly sales, four plants (US & UK) and produced over two billion units per year of high volume glass, plastic and rubber disposable blood collection devices as a strategy to counter a Japanese entry into B-D’s market that had taken 40% of market share from B-D in 5 years. Provided QAE support to a quality improvement program that help regain all lost market share and increase it 10% over pre-threat level in four years.
• Directed the design of new facility for startup in vitro diagnostic reagents, H/W & sterile plastics (IVD) facility. Vendor program saved $300K in costs. 

• ASQ Quality Conference led session on PAT in Pfizer 2005. Lead American Society for Quality, Seminar on Computer System Validation in 2003, 2002, 2001, 2000 and 1999. 
• Developed and hosted American Society for Quality, Seminar on Computer System Validation, Jan. 22, 1998, Radisson Htl, Seacaucus, NJ. Presented session on, Model Life Cycle for Software Validation. 
• Chaired and organized ASQ’s Metropolitan Section 53rd Annual Deming Conference, Practical Applications of Deming’s Philosophy. December 8-10, 1997. Resorts Hotel, Atlantic City, NJ. 
• Chaired and organized ASQ’s Metropolitan Section 52nd Annual Deming Conference, Deming’s System of Profound Knowledge. December 9-11, 1996. Resorts Hotel, Atlantic City, NJ. 
• Chaired and organized Seminar on Leadership and Quality Improvement, February 7, 1995, Fordham University, NYC. Presented session on Leadership and Human Emotion.

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:

Summary:

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.

Details:

• Purchased, operated, and interpreted Analytical Research Lab data including a Nicolet FTIR Microscope with Micro ATR objective and Mettler Hotstage, Perkin-Elmer GC/MS, and a SIS Thermal Desorber (ThDsb) for GC/MS sample introduction. Developed numerous analytical methods using such lab instruments to quantitate and characterize the application of drugs and other active surfaces to drug-eluting stents, catheters, and other implantable medical devices for preventing restenosis, pain, infection, excessive friction. Completed various cardiology catheter extrusion and material science/spectroscopic characterization studies for catheters and respiratory devices.
• Installed, operated, interpreted, and maintained Analytical Research Lab including: a Shimadzu GC/MS with a Direct Insertion Probe, a SIS ThDsb, a Hewlett-Packard GC with an FTIR Detector, and a Nicolet FTIR Microscope with Micro ATR and Mettler Hotstage. Sherwood's expert in polymer, elastomer, and biomaterial processing, technology, chemistry, physics, characterization, analysis, and additives. Developed numerous methods of ThDsb/GC/MS and ThDsb/GC/IR analyses to identify and quantitate coatings, drugs, contaminants, "blooming" and additives in and on medical devices, and contaminants, vent clogs, plate out, and causes of corrosion on injection molds and other processing equipment. Troubleshot various processes to eliminate "blooming", vent clogs, plate out, corrosion contaminants. Developed numerous methods using Nicolet software and Micro ATR FTIR for "instant analyses on contact" of many devices for quantifying radiation dose, plasticizer content, formulation, durometer. 
• Part of team that ended voluntary recall of extremely successful bioresorbable implant, AngioSeal arterial puncture closure device. Designed polarized microscopy videotaping analytical method that identified the molding defect causing spurious low break force failures. Correction of this defect ended recall and maintained critical production launch. Eliminated bubble formation during AngioSeal molding, preventing a recall and maintaining critical production launch. Prevented shutdown of $100 MM/yr. syringe factory by rapid solution of resin problem and development of FTIR method and software for statistical incoming inspection of pellets by factory labs. 
• Part of team that implemented new material for Genius Tympanic thermometer that could withstand cleaning chemicals without cracking, improving quality/saving millions of dollars in replacement costs. Worked on numerous implantable, bioresorbable and biostable coated/drug coated devices.
• Consulted start-up company on all technical issues involved in startup of new plastic medical devices product including design, mold acquisition, production cost analyses, raw material selection and prototyping.
• Managed Analytical Research Lab including a Hewlett-Packard 5890 Series II GC with a Thermo Nicolet Infrared Detector and software, and a Thermo Nicolet FTIR Microscope with ATR objective and Mettler Hotstage. B-D's expert in polymers, additives, formulation, deformulation, and competitive analysis. Team participant in first release of E Beam and Gamma sterilized syringes in the USA. Wrote all the Engineering Change Orders and implemented all these new high melt flow polymers. This increased productivity 14%, saving millions of dollars per year, and dramatically decreased the number of injection molds required for production. Patented radiation stable polyolefin formulation. 
• Completed a number of projects at DuPont’s Potomac River Works Development Laboratory in Martinsburg, WV that involved polysaccharide hydration, crosslinking, thermal stability, and shelf life.

• “Predicting Shelf Life from Accelerated Aging Data: The Variable Q10 and D&A Techniques” in MD&DI magazine; June, 1998; J. Donohue, S. Apostolou.
• Medical Design and Manufacturing Conference Proceedings; Anaheim, CA; February, 1997; “How to Predict Shelf Life from Accelerated Data”, J. Donohue.
• METCON ’96; Worldwide Metallocene Conference; Houston, TX; June, 1996; “Syndiotactic Polypropylene: Stability to Gamma Radiation”, J. Donohue. 
• ANTEC ’96; The Annual Technical Conference of the SPE; Indianapolis, IN; May, 1996; “The Donohue and Apostolou Process: Predicting Post-Rad Shelf Life from Accelerated Aging Data”; J. Donohue, S. Apostolou.
• SPO ’95; Business Forum on Specialty Polyolefins; Houston, TX; September, 1995; “Syndiotactic Polypropylene: Radiation-Induced Oxidative Degradation”, J. Donohue.
• “Metallocene Catalysts: Driving the Polyolefin Revolution”; in Medical Plastics and Biomaterials magazine; Fall, 1994, J. Donohue.
• ANTEC ’94; San Francisco, CA; May, 1994; “Thermal Decomposition of Bis-Toluidene Sorbitol into Benzoates during the Molding of Polypropylene”, J. Donohue. 
• SPO ’93; Houston, TX; September, 1993; “The Fire Within: Post-Irradiative Degradation of Polypropylene”; J. Donohue, S. Apostolou.
• ANTEC ’91; Montreal, Quebec; May, 1991; “Radiation Initiated Oxidation of HALS Stabilized Polypropylene”, J. Donohue.
• ANTEC ’90; Dallas, TX; May, 1990; “Radiation Effects on Polymers and Hindered Amine Light Stabilizers”, J. Donohue.
• “Free-Radical Degradation and Protection in Irradiated Plastic”; in MD&DI magazine; April, 1990, J. Donohue.
• “Shelf-Life Prediction for Radiation-Sterilized Plastic Devices”; in MD&DI magazine; January, 1990; J. Donohue, S. Apostolou.
• United States Patent No. 4,710,524; Granted December 1, 1987; “High Energy Radiation Stabilization of Semi-Crystalline Polymers”; Inventor, John Donohue; Assigned to Becton Dickinson.

William J. Scherder, pharmaceutical, vaccine processes and equipment, engineering analysis; computer analysis; power plant engineering, consultant, expert. He has had an impressive and verifiable list of industrial accomplishments for 19+ years in validation, regulatory compliance,  power plants engineering and management.  His validation and regulatory compliance record includes:

Summary:

William Scherder is Director of Validation - Medical Device/ Pharmaceutical/ Biotechnology and Power Plant Engineering Services for TechnoBusiness Solutions. He is well known in the medical device industry since 1989. Developed and reviewed equipment specifications, factory acceptance testing, engineering studies, and qualification activities through process validation for pharmaceutical packaging equipment and processes. Projects ranged from product/line extensions to new products/lines. Developed and ensured adherence to project plans and schedules. Developed validation strategies which included: protocol generation and execution of engineering studies, commissioning, installation and operational qualifications, and performance qualifications.  These activities were related to liquid, ointment, cream, and tablet filling / thermoforming lines.  Developed, performed and reviewed commissioning, installation and operational qualification of simple GMP and non-GMP computer systems and programmable logic controllers.  Managed up to 6 contract validation specialists hired to perform qualification activities for pharmaceutical packaging equipment within the scope of an FDA consent decree.  Responsibilities included: technical oversight, budget planning and scheduling.  

Technical Lead – Managed the accident analysis functional area (FSAR Chapter 15) for power plants operated by the Southern Company, a Westinghouse premier customer.  As a primary customer interface, proposed engineering solutions to customer, conducted off-site customer training courses, supervised and coordinated the activities of other engineers and technicians.  Performed thermal hydraulic analyses of transients in nuclear power plants using a variety of PC and UNIX based computer programs.  Primary function included computer simulation, preparation of engineering reports, and 10 CFR 50.59 safety evaluations for the utility customer and the US Nuclear Regulatory Commission.  Developed finite difference models for power plant steam generators.

Business Unit Coordinator/Fluid Systems Analysis – Coordinated computation, distribution, and approval of thermal hydraulic parameters for power plant modifications. Position required a significant attention to detail as the calculated parameters form the basis for all analyses related to major programs.  Interfaced with all major engineering disciplines within the corporation, and with the utility/customer personnel to reach consensus and determine acceptable thermal hydraulic parameters that satisfied economic, safety, design and contractual requirements. Project Management – Managed external customer projects of varying size.  These projects required the teamwork of several internal functional groups.  Responsibilities included proposal of engineering solutions to the customer, development of budget estimates, manpower plans, supervision of analysis activities, preparation of final reports, and ultimately the defense of the engineering approach and report to the customer and the US Nuclear Regulatory Commission.   For larger projects, was also responsible for the coordination of functional group activities, including the analysis strategy, and team progress. Regulatory/Licensing – Functional group expert for power plant modifications related to instrumentation and control digital equipment, fluid systems and mechanical component modifications and replacements. Authored licensing report sections, developed technical strategies and solutions, authored safety evaluations, and safety assessment reports supporting plant modifications and upgrades related to I&C, fluid systems, and mechanical systems.  Updated required licensing documentation and defended changes to the US Nuclear Regulatory Commission.  Functioned as the Technical Lead for the verification and validation of the primary licensed analysis computer model for the next generation advanced power plant.  Developed a successful technical approach, supervised computer model modifications and team input to licensing documentation, authored licensing report, managed schedule and defended to regulatory body. 

Mr. Scherder worked at the University of Pittsburgh Material Science & Engineering Department as a Graduate Research Assistant – Designed an experimental apparatus for measuring the mass transfer coefficients of polymer/monomer devolitization under a forced flow field. In addition, He was Graduate Teaching Assistant for Mechanical Design Course and Lab Instructor for Mechanical Measurements Course, both for the Mechanical Engineering Department,  University of Pittsburgh Medical Center Clinical Chemistry – Lab technician (1987 – 1989) Part time (20 hours/week) employment while obtaining graduate degree.

Mr. Scherder  has been received a M. S. Mechanical Engineering and B. S. Chemistry, cum laude degrees from the University of Pittsburgh.  In addition, he has received a  A. S. Biology degree from the Community College of Allegheny County.

Pharmaceutical Consultant, Regulatory Compliance Consultant, Pharmaceutical Quality Assurance Expert, Quality Control Consultant, Regulatory Compliance Consultant, Product Development Consultant, Due Diligence Audit, Investigation, Expert, Engineering, Consulting, Services, Validation Study Consultant, Specialist, Investigation, Expert, Engineering, Consulting, Services
Expertise in quality control, quality assurance and regulatory affairs, medical products businesses, chemistry, manufacturing and controls (CMC) section of drug master files, DMFs, analytical methods and process plans, protocols and reports, form FDA 483 and warning letter responses, corrective and preventive action plans, training, general cGMP, general validation, and test method validation, negotiations with regulatory agencies, customers, distributors and internal group, data analysis including specification development and rationalization, trend analysis, expiration and retest date justification, test method characterization and validation, site qualification processes, product design validation documentation, test method validation document evaluation, data traceability audits, manufacturing process validation master plans, new product development, planned discontinuance of out-dated products, NDA pre-approval inspections, corrective actions, responses and re-inspection, chemical manufacturing processes, good manufacturing practice (cGMP), total quality management and ISO 9001 registration processes, in vitro diagnostic reagent, instrument design control and quality control. Expertise in pharmaceutical quality assurance, quality control, project management, regulatory affairs, product development, management, 26 years experience in product development, process development, validation, large scale manufacturing facility validation and startup, process development, validation, production management, quality assurance, quality control of FDA licensed biotechnology, small molecule and device products, regulatory experience, GMP audit, regulatory compliance, quality system development, validation, document control, laboratory management, facility environmental monitoring, internal compliance and auditing, process validation, microbiologic and chemical testing of materials and finished product, product stability, plant EM, product test and release programs, stability programs, instrument validation, and cleaning validation programs, statistical process control based production planning, QC laboratory management, drugs, ointments, creams, tablets, aseptic processing, powders, dissolution rate, deformulation, remediation, significant investigations, variances, protocol deviations, preventative actions, corrective actions

* Except any incurred travel, lodging and conference room expenses.

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