Consultant

  (610) 462-4090

  info@qualitysolutionsnow.com

Consulting professional with over 30 years of management experience in packaging, labeling, change control, production engineering, purchasing, and operations. Technical and project management knowledge gained in working with top drug, cosmetic, medical device, and food manufacturers. Background includes pharmaceutical, animal drug, catheter, diagnostic kit, cream and ointment, and supplement products.

CORE COMPETENCIES

  • Project Management/Change Management
  • Product Development
  • Primary Packaging Design
  • Secondary Packaging Design
  • Tertiary Packaging Design
  • Controlled Temperature Shipping
  • Labeling Development
  • Package and Equipment Design
  • Packaging Operations/Process Controls
  • FDA 21 CFR Parts 210/ 211/820
  • Gap Analysis/Impact Assessments
  • Internal Audits/Supplier Audits
  • Change Control
  • Corrective and Preventative Action
  • Root Cause Analysis
  • Failure Investigations
  • Procedural Development
  • Specification Development

SELECTED ACCOMPLISHMENTS

  • Developed primary and secondary packaging for drug manufacturer of respiratory product and liquid API that is ingested requiring special handling and product delivery requirements
  • Completed packaging development tasks for drug manufacturer of new weight loss product, including:
    • Designed primary and secondary packaging, preparing required packaging specifications
    • Created primary material testing protocols
    • Coordinated all distribution testing
  • Managed packaging initiatives for manufacturer of chemo drug, including:
    • Replaced primary packaging material by sourcing pouch material suppliers
    • Developed laminate material for slow release, moisture sensitive product
    • Developed all packaging specifications and test protocols
    • Coordinated outside test lab qualification testing
    • Developed comparability protocol for FDA submission
  • Specified packaging components for manufacturer of new animal drug product, including:
    • Developed primary and secondary packaging specifications
    • Designed special tray package to hold 10 vials with foam protection
    • Designed custom cold pack for delivery of product requiring transport at 2ºC to 8ºC for 72 hours
    • Coordinated cold chain and distribution testing
    • Developed finished labeling artwork
  • Managed various packaging project activities for medical device manufacturer of catheter-based therapeutic products, including:
    • Redesigned primary and secondary packaging to correct ship test failures for surgical kit redesign due to leakage failure during shipping
    • Constructed samples for testing
    • Developed new packaging specifications for all levels of packaging
    • Facilitated packaging line trials in house
    • Coordinated distribution analysis testing at outside lab
  • Led numerous project efforts for medical device manufacturer of test kit for HIV testing, including:
    • Conducted field testing of kits
    • Sourced components for all primary and secondary parts
    • Coordinated all container/closure testing
    • Coordinated distribution analysis testing, including environment controls
  • Led labeling/packaging transfer for drug manufacturer of Rx solid dose products, including:
    • Facilitated technology transfer and site evaluations during merger of two companies
    • Managed packaging/labeling team for all product integration
    • Invented and internationally patented tablet recovery system generating profit and savings in excess of $2,000,000 per year
    • Received award for six-month early launch of tablets to help control HIV infection
  • Performed engineering function for manufacturer of cosmetic products, including:
    • Managed all package and equipment design
    • Sponsored value analysis/cost reduction program resulting in five-year total savings of $10,000,000 in packaging/process changes
    • Acted as team leader on MRP II implementation program
    • Served as manufacturing site representative for all marketing teams for new and improved product launches
    • Conducted site meetings and maintained project schedules and budgets for all product launches and extensions
    • Conducted line trials and test production runs in packaging and manufacturing in conjunction with Marketing and Product Development
  • Led and managed change control operations for drug manufacturer of consumer healthcare, vaccine, and prescription medication products, including:
    • Directed cross-functional team that developed new comprehensive change control process
    • Implemented centralized change control process for U.S. and Canadian operations
    • Managed on-time processing, accuracy, and compliance of all changes that impacted products produced and distributed in U.S. and ROW market (process times reduced to no more than 14 days)
    • Served as U.S. representative for all world-wide change control activities and led two international workshops
    • Established as point of contact for change control and process deviation issues during FDA audits and inspections and conducted numerous successful audits
    • Provided expert recommendations and consultation to local and global product development teams, technical working parties, new product scale-up teams, and new product pre-approval matrix teams
    • Led and assisted in audits of critical contract and component/raw material suppliers
    • Managed investigations of product/process deviations, exceptions, and complaints to determine root causes and corrective actions
  • Managed variety of purchasing activities for drug manufacturer of pharmaceutical products, including:
    • Managed performance of buyers and other purchasing specialists
    • Negotiated contracts for capital purchases of equipment and MRO/operating supplies
    • Provided support to all engineering functions in preparation of confidentiality disclosure agreements and patent submissions
    • Established contracts program for qualified suppliers of goods and services insuring compliance with cGMP requirements and hazard communications, and developed and implemented policies and procedures
    • Developed and implemented methods for cost savings reduction for supplies and equipment resulting in millions of dollars in savings per year
    • Led team of inter-company associates and local town officials in successful pursuit of natural gas services to facility, resulting in utility cost savings
    • Led supplier certification program and established criteria for qualifications
  • Managed construction and startup of 70,000 sq. ft. particleboard laminating facility for chemical process plant, including:
    • Developed specifications, negotiated, and purchased plant equipment from Europe
    • Coordinated complete plant start-up on schedule with $10 MM budget, specifically project feasibility, incorporation, accounting systems, personnel hiring, sales and marketing assistance, technology transfer, building construction, equipment installation, raw material sourcing, contract negotiations, training and start-up, environmental and safety compliance, and hazard communication program
  • Completed construction and start-up of 400,000 sq. ft. modern snack food bakery for food manufacturer, including:
    • Managed operations with $45,000,000 budget for two facilities with total employment of 1000 union associates
    • Developed successful plan for existing facility closing and equipment relocation operations to new facility
    • Developed and implemented cost reduction and policy/procedure programs for cGMP compliance
    • Completed implementation of MRP II program, preventive maintenance management program, and business resource planning
  • Provided national seminar and training classes in areas of packaging and labeling, change control, compliance, complying with SUPAC, CAPA, FDA systems-based inspection, quality systems, cGMP compliance, risk management, internal auditing/supplier auditing, clinical supplier auditing, and investigations

PROFESSIONAL EXPERIENCE

  • Ingram Consulting Services, Inc., Consultant (Angier, NC)
  • (Contracted with Pharmaceutical Training Institute, PharmaDirections, Inc., Teva Pharma,
  • Arrow International, Medicis Pharmaceutical, Merck, Sandoz, Novartis, Cangene, Neurotech Inc., APlus Secure Packaging, BioNet Pharmaceutical Center of NC, GMSI, and Tunnell) – 2001 to Present
  • Glaxo Smith Kline, Inc., Change Control Mgr. (Zebulon, NC) – 1998 to 2001
  • Glaxo Wellcome, Inc., Principal Production Engineer (Zebulon, NC) – 1997 to 1998
  • Glaxo, Inc., Sr. Buyer Purchasing (Zebulon, NC) – 1992 to 1997
  • GVK America, Inc., Plant Operations Manager (Biscoe, NC) – 1990 to 1992
  • Bahlsen, Inc., Plant Manager (Cary, NC) – 1986 to 1990
  • Almay, Inc., Senior Manager of Engineering (Oxford, NC) – 1979 to 1986

EDUCATION

  • Associates Degree, Engineering Sciences, Central Carolina Technical College, Sanford, NC – 1973
  • Work towards B.S, Campbell University, Buies Creek, NC

CERTIFICATION

  • Certified Packaging Professional (CPP), Institute of Packaging Professionals – 2007

AFFILIATIONS

  • Member of Consultants Council for Institute of Packaging Professionals (IOPP)
  • Chairman of Board of Directors of Consultants Council of IOPP
  • American Institute of Plant Engineers (AIPE)
  • Institute of Industrial Engineers (IIE)
  • National Association of Purchasing Managers (NAPM)
  • Institute of Packaging Professionals (IOPP)
  • Member of College of Fellows for IOPP
  • Board of Directors for Wake Technical College Foundation
  • Board of Directors for Native American Health Education Fund
  • Institute of Packaging Professionals Consultant’s Council

PUBLICATIONS

  • “Capital Justification Process”, Packaging Digest
  • “Daily Supplier Report Card”, Pharmaceutical & Medical Packaging News
  • “Maintaining Production During Expansion”, Food and Drug Packaging

PATENTS

  • Patent #5,442,892 Tablet Recovery System