Howard Cooper


A.    Background Summary

·         Over 40 years designing, implementing, and managing GMP and Regulatory Affairs systems

·         Development, clinical trial, and commercial pharmaceuticals, biologicals, medical devices, & in vitro diagnostics, Nutraceuticals-Includes some combination products

  • BS Biology-Chemistry & Political Science; 32 credit hours toward an MBA
  • CQM, CBA, & CQA
  • Submitted device applications and provided QA support in the preparation of CMC for IND/NDA submissions
  • Chairperson, ASQ Biomedical Midwest Discussion Group,2012 & Other Offices from 2008-Present


  1. Areas of Expertise

·         Designing & implementing GMP systems

·         Consent decree and warning letter experience

·         Supplier & outsourcing qualification

·         Pre-Approval Inspections (PAI)


·         Corrective and Preventative Action (CAPA) systems

·         Documentation & Change Management

·         Regulatory submissions

·         Medical Device and Pharmaceutical Quality Systems


  1. Management Skills
·         Managing People/Leading Groups

·         Changing/Improving Systems & Processes

·         Diagnosing & Evaluating Situations


·         Persuading and Negotiating

·         Systematizing

·         Problem Solving


  1. Examples of Professional Accomplishments


  1. Visualizing, designing, & implementing GMP Quality Systems that resulted in successful product launches


  • Directed the design, staffing and implementation of a startup combination medical device & pharmaceutical manufacturing and packaging operation-manufactured drugs, devices, &, combination products. Included design controls (not required by the device GMP’s at that time) and control activities throughout the product lifecycle.


  • Directed the design, staffing, startup, and commercialization of facilities manufacturing active pharmaceutical ingredients, drug products, and medical devices-included two incubator companies (device & pharmaceutical) and pharmaceutical site manufacturing active pharmaceutical ingredients and finished pharmaceuticals.


  • Directed the development & implementation of a Quality and Regulatory Affairs function for a medical device company importing Class I & II products from Asia and Europe . Included provisions for ISO 13485 certification which was achieved quickly. Quality system featured Design Controls combined with strong Purchasing Controls supported by incoming testing and controls.


  • Audited & assessed pilot production facility for a developmental nutraceutical product in order to prepare a plan for constructing a new facility that would be compliant with the required GMP quality system requirements. Included a complete set of flowcharts showing all inputs and outputs. Included project tasks. Included input from all functions.


  1. Auditing and diagnosing improving & remediating quality systems


  • Assisted a small medical device manufacturer work with a foreign device manufacturer to resolve design control issues (Spring 2015)
  • Assisted Senior Management and Legal Counsel assessing major quality and compliance Issues including merger with another medical company- Large Corporation-$8.5B Total Sales (FDA Products $1B) (Summer-Fall 2015)


  • Consent Decree-Intl. Biological Manufacturer-joined the company to assess the quality system failures and recommend and implement solutions: -participated in the following activities
  • Designed & implemented supplier & outsourcing programs, including databases for managing audits, contractor & supplier qualification, follow-up & corrective action, raw material specification controls, and risk-based reduced testing programs. Led an external auditing group as well as lead team audits of suppliers and contractors
  • Provided support, as needed, to the internal auditing function
  • Member of the Facilities Management and Computer Validation team
  • Participated in close-out meetings and briefings
  • Interfaced with FDA on consent decree related activities


  • Warning Letters-Large pharmaceutical manufacturing company


  • Assisted a division of the company respond to an FDA 483 findings and implement solutions
  • Led a multi-functional ad hoc group to respond to a 483 findings linked to a warning letter-this multi-functional group developed corporate-wide policies and equipment maintenance and calibration for all domestic and international operations.


  • Revamped facilities to comply with the 1976 Medical Device Amendments-small medical device contract manufacturer
  • Implemented a GMP quality system for contract medical device manufacturer when the medical device industry became regulated by the 1976 medical device amendments
  • Established A Regulatory Affairs function for the submission and approval 510K products


  • Medical device components manufacturer with quality issues (3 sites)
    • Used Pareto and SPC identify the causes of failures
    • Implemented successful quality system improvements and regained customer confidence


  • Virtual biological manufacturer of an injectable combination device-biological product(Ophthalmic)-Phase 3-NDA submitted to FDA
    • Prepared and implemented QA remediation plan in preparation for preapproval inspection-passed FDA scrutiny
    • Assessed & identified “show-stopping” contract manufacturing issues -identified remediation team


  • Led a cross functional team to qualify a monoclonal antibody (MAB) contractor for a life-sustaining biological. Quickly learned the MAB production and purification process and the associated regulations. Directed corrective actions and assisted in the technology transfer. Resulted in project goals being met.


  1. Regulatory Affairs


  • 510K Submissions
  • Assisted in “re-vitalizing” a 510(k) having major submission deficiencies achieving FDA clearance (Small device manufacturer (Winter-Spring 2015)
  • (Began 510K submissions work when the 1976 Medical Device Amendments established the medical device classification and approval systems
  • Prepared/written and submitted 510Ks, worked in team environments, & advised and directed 510K activities
  • Examples of product categories include:
    • Urological & gynecological
    • Devices with adhesive constructions such as wound care, electrodes, & TENS
    • Brachytherapy
    • Inhalation control instrumentation
    • Drug delivery devices (primarily syringes & pens
    • IVF
    • Pharmacy compounding
    • Anesthetic
    • Dental
    • Food (Primarily Beverages)
    • Cosmetics
    • Dietary Supplements


  • Designed and implemented internal group to audit Abbreviated New Drug Applications prior to submission for compliance, data integrity, and congruency between internal documentation and the CMC sections (large generic manufacturer.)


  • Persuaded FDA to reclassify a product from drug to medical device, then guided efforts to obtain approval via the 510K route (mini-PDA), resulting in speedier approval of the device


  • Successfully petitioned NRC medical committee to amend regulations adding palladium as a standard radioisotope for medical use. Improved shipping efficiency and delivery time to customer


  • Clinical Studies-
    • Managed clinical trials for brachytherapy devices
    • Reviewed clinical study data and reports as part of the submissions process
    • Monitored clinical trial activities


  • New product promotion-advised large medical device company concerning claims for new product-Winter 2015


  1. Training & Instruction


  • Directed the training for personnel in a combination medical device and drug facility to include on-the- job and GMP training. Utilized GMP workbooks, seminars, and outside consultants as well as personal direction. Expanded training to include other affected USA & European sites.
  • Assisted in leading a large Pharma’s ad hoc GMP Training Improvement team to improve introductory GMP training. Efforts resulted in improved attendee course tests and evaluations.
  • Currently conduct quality training sessions at professional organizations, on-line, and on-site using a combination of text & graphics to illustrate quality concepts
  • Tutored and mentored personnel and consultant clients to develop their leadership and technical capabilities


  1. Experience

1, Independent Consultant, EQACT, Inc.-2004-Present

  • Provided compliance and quality consultation to Pharmaceutical, Medical Device, and Biological Companies
  • Designing, Developing, and Implementing GMP Quality Systems
  • Developed and implemented GMP systems for virtual & brick-and-mortar companies
  • Audited and Qualified contractors and suppliers in the USA, Europe, & India

·         Conducted GMP training for Medical Companies and Professional Organizations


  1. Associate Quality Consultant, Corporate QA Research, & Development, Eli Lilly and Company, Indianapolis-2000-2004
  • Provided compliance and quality consultation to Corporate and Third Party sites developing new products. Included branded products as well as joint agreements with other pharmaceutical companies. Included sites in the United States, Japan, & Europe.
  • Led and participated in audits of Corporate, Third Party, and contract sites. Included follow-up to assure corrective and preventive action was complete and effective.
  • Involved in the ongoing review and approval of Corporate QA/GMP policies

·         Corporate QA Consultant to Company’s Medical Device Operations


  1. External Audit Group Leader, Aventis-Behring, Chicago area1997-2000
  • Implemented a supplier audit and qualification program to meet FDA regulations
  • Performed and led supplier qualification audits and supplier quality improvement activities
  • Provided quality and compliance expertise to Computer Validation, Materials Management, and Laboratory Information Management Project


  1. Pharmaceutical Compliance Manager, BOC Gases/Ohmeda Pharmaceutical, Baton Rouge 1994-1997

Managed the QA/GMP function for design, startup, and validation of bulk and finished drug facilities. Assisted in the quality and regulatory management of medical gases.


  1. Manager, Regulatory Compliance, Lemmon Company, Div. of TEVA Pharmaceutical, Philadelphia. 1991-1994

Managed the compliance function for manufacturing solid and liquid dosage forms. Developed and managed internal and external audits including a group dedicated to reviewing submissions to the FDA. Participated in process validation.


  1. Director, Medical & Regulatory Affairs, Theragenics Corporation, Atlanta 1988-1991

Directed development of GMP Quality System from incubator to commercialization and directed FDA submissions work.


  1. Manager, Regulatory Affairs & Quality, Avery Medical, Div. of Avery, Cleveland 1982-1988

Directed the design and development of a combination medical device and transdermal drug GMP Quality system


  1. Director, Quality Assurance, Akron Catheter/Latex Industries, Cleveland 1977-1982

Implemented the Medical Device Amendments (Quality & Regulatory) for contract manufacturing


  1. Technical Support Representative, Gilford Instruments 1973-1976

Responsible for compliance of manuals and procedures for an in vitro diagnostics instrument and reagents


  1. Assistant Dept. Head, Brewing Quality Control, Anheuser-Busch, St. Louis, & Cleveland 1968-1973

Completed the Quality Management Program then managed incoming, in-process, and finished product quality at the Columbus brewery


  1. Educational Background & Professional Affiliations


  1. BS, Biology/Chemistry & Political Science, University of Arkansas, Little Rock, AR
  2. 32 credit hours toward an MBA, Lake Erie College, Painesville, OH (GPA=3.6/4.0)
  3. American Society for Quality -CQA & CQM Certification; Biomedical Quality Auditor Certification
  4. Member of ASQ, PDA, RAPS, MWSQA, Association for the Advancement of Medical Instrumentation (AAMI)