Pharmaceutical and Medical Device GMP and Compliance Expert

Technical Consultant #1864


Expertise

  • GMP and ISO matters relating to quality control and quality assurance in the medical device, dietary supplement and pharmaceutical industries.
  • Good Manufacturing Practices (GMP), and ISO Certified Lead Auditor.
  • Document control, training, supplier and quality assurance.
  • Auditing, document control, training, supplier and contract quality assurance.
  • Process validation and contractor management
  • Quality control and quality assurance for a facility producing tablets, aerosols, suppositories, time-release capsules, medical devices and small volume parenterals. Injection and blow molding clean rooms.
  • Managed NDA and ANDA product approval inspections, annual inspections and DEA (Drug Enforcement Agency) controlled drug inspections.
  • As Quality Coordinator for Hollister, Inc: Supervised quality control function in pilot plant.
  • Performed government contract review/approval, complaint handling, incoming inspection, change control and supplier qualification.
  • Prolific author and presenter, authored the internationally acclaimed text GMP/ISO Audit Manual for Healthcare Manufacturers and their Suppliers.
  • As Chemical Technical and Quality Engineer for Baxter Travenol: Performed chemical analysis on raw materials resident expert on injection molding, disposable needles and syringes for international division.
  • Developed auditing, document control, third party, incoming quality assurance, supplier and contractor control systems in their entirety, for world-class companies.

Expert Witness Experience

  • Analyzed data and provided reports for use in product liability cases.

Experience

Independent ISO and GMP Consultant, 2002 - Present

  • Performed gap analysis and consulting of facility versus new Nutritional GMP's.
  • Provided courses on GMP requirements and FDA inspection preparedness to domestic and foreign drug and device firms anticipating FDA inspections.
  • Performed clinical drug supply production facility audits.
  • Audited contract laboratories for research and development and quality assurance testing.
  • Audited numerous drug, medical device and dietary supplement manufacturing operations.
  • Developed device and Drug Quality Systems Manuals.
  • Performed PAI readiness audits.
  • Analyzed data and provided reports for use in product liability law suits.
  • Performed ISO 9001-2000 surveillance and registration audits For Perry Johnson Associates.
  • Assisted firms on 483 and Warning Letter resolution and responses to FDA.
  • Performed GMP training at medical device facilities.
  • Reviewed nonconformance investigations and provided corrective/preventive action guidance for remediation of FDA consent decree requirements for Abbott, Schering and J & J.
  • Evaluated drug distributor and prescription dispensing operations.
  • Performed API audits.
  • Wrote SOP's for client firms.

Abbott Laboratories, Abbott Park, IL, 1982 - 2002

Positions
Manager, Quality Systems Training
Manager, Internal Audit Systems
Manager, IQA & Document Control
Validation Projects Leader
Manager, Contract Quality Assurance

  • Derived a Quality System Manual for third-party contract manufacturing operations.
  • Derived and managed a global GMP training system.
  • Derived and managed a worldwide internal audit system for compliance to GMP and ISO.
  • Audited 9 international manufacturing locations annually for four years.
  • Standardized the performance of internal audits at 11 manufacturing sites through the use of audit checklists and reporting of metrics to division management.
  • Developed and managed a cost and quality effective incoming quality assurance program; including a supplier certification program.
  • Developed validation protocols and managed associated validation runs for new product projects.
  • Internal Audit System inspected by FDA 4 times; no observations.
  • Training System inspected by FDA 1 time, no observations.

Searle Pharmaceuticals, Inc., Skokie, IL, 1978 - 1982

Positions
Director, Quality Assurance
Compliance Manager

  • Managed all quality control and quality assurance functions for a sterile product manufacturing location that also produced tablets, capsules, liquids and aerosols.
  • Acted as the quality assurance liaison to Regulatory Affairs on new drug applications and 510K submissions.
  • Managed the product complaint handling function.
  • Derived and managed a global document control function.
  • Derived and managed a global internal audit function.
  • Directly accommodated 7 FDA Inspections, including NDA/ANDA approvals: 1 observation (room use log book concern).
  • Directly accommodated 1 DEA (controlled drug) inspection; no observations.
  • Directly accommodated 1 ATF (Alcohol, Tobacco and Firearm) inspection; no observations.

Arnar Stone Laboratories, Mount Prospect, IL, Quality Assurance Auditor, 1977 - 1978

  • Audited and assisted in the qualification of a new, small volume parenteral production facility.
  • Performed audits of internal facilities, suppliers, and contractors.
  • Participated in small volume parenteral production facility FDA approval inspection.

Hollister Incorporated, Lincolnwood, IL, Pilot Plant Quality Assurance Supervisor, 1974 - 1977

  • Designed and supervised the quality control function in the pilot plant.
  • Performed internal and supplier audits.

Baxter Laboratories, Morton Grove, IL, 1969 - 1974

Positions
Quality Technician
Quality Engineer

  • Performed USP testing on raw materials and finished products.
  • Provided quality engineering support to ten international production locations.
  • Reviewed and approved injection molds for components.

Honors & Publications

Credentials

  • Certified Quality Engineer
  • ISO Certified Lead Auditor

Awards

  • The GMP Institute - Inducted into the GMP Hall of Fame for Auditing

Publications and Patents

  • GMP/ISO Quality Audit Manual for Healthcare
  • 9 article series on GMP Training Systems for FDA News and Information Newsletter
  • 3 article series on Internal Audit System Ailments for FDA News and Information Newsletter
  • Article on Random Roving Inspections for FDA News and Information Newsletter

Education

  • B.S. Psychology and Chemistry, Elmhurst College, Elmhurst, IL
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