Pharmaceutical and Medical Device GMP and Compliance Expert

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