My career has spanned almost 50 years beginning with Norwich-Eaton Pharmaceuticals ( Norwich, NY, Brantford, Ontario and Greenville SC), Carter Wallace laboratories ( Decator IL), Cumberland Swan ( Smyrna, TN), Perrigo (Allegan MI), Banner Pharmacaps ( High Point NC), Herbalife ( Los Angeles, CA) and Pharmachem Laboratories ( Kearny, NJ).
All of the positions involved managing Quality Control, Quality Assurance, Documentation Control responsibilities relative to Plant GMP Compliance ( Prescription, OTC, Dietary Supplement and Food categories). In most cases the responsibilities were US multi-plant locations. I have also had experience interacting with regulatory agencies in Mexico, Brazil, Canada and China.
The overall responsibilities covered quality systems associated with the following areas:
- Receiving, Testing and Release of Raw Materials, Finished Product and Packaging components
- Development of Raw material, Finished product and Packaging component specifications
- Warehouse controls associated with received components
- Development and approval of Master Manufacturing, Production and Packaging Batch Records
- Cleaning and Sanitizing of Manufacturing and Packaging Equipment
- Environmental Monitoring
- Training Programs
- SOP Development and approvals
- Complaint Programs
- Returned Goods
- Recall Procedures
- Raw Material Supplier Qualification program
- Third Party Laboratory Verification and Approvals
- Internal and External audit programs
- Handling of FDA Audits
- Handling of Third Party Audit Programs ( NSF, FSSC 22000)
- Pest Control program
- Calibration Programs
The hands on experience at the plant level early in my career and later providing management direction to quality and operations departments has allow me to implement a very practical interpretation of applicable regulations which results in quality systems that minimize compliance challenges.
I have been directly involved in FDA GMP inspections of many US facilities. This participation included during the audits, post inspection exit discussions and finalizing responses to any FDA-483 observations that may have been noted.