- 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.
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
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
Director, Quality Assurance
- 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
- 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
- Certified Quality Engineer
- ISO Certified Lead Auditor
- 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
- B.S. Psychology and Chemistry, Elmhurst College, Elmhurst, IL