Negotiated manufacturing documentation in CMC section of three INDs, including site qualification processes, to assure consistency of stem cell, and pancreatic islets processing in two multi-center (3 to 10), Phase 3, NIH-sponsored clinical trials.
Upgrading Quality System of European subsidiary of US IVD company.
Led team that wrote major section of IVD Product Design Validation document
Evaluated over 200 test method validation documents
Trained over 300 people in test method validation
Advised materials control team on quality and regulatory compliance
Wrote CMC sections for 4 INDs.
Conducted numerous audits of API manufacturers, testing labs and suppliers.
Conducted numerous data traceability audits for finished drug stability studies.
Coordinated interactions of NDA team with API manufacturer
Wrote API manufacturing process validation master plans
Wrote manufacturing process validation protocols and final reports
Active member of 9 Project Teams, leading 3 of them, ranging from new product development to planned discontinuance of out-dated products.
Led an Active Pharmaceutical Ingredient manufacturer through its first NDA Pre-Approval Inspection (PAI) and subsequent corrective actions, responses and reinspection to gain FDA District approval recommendation for two NDAs.
Organized and documented the validation of API peptide chemical manufacturing processes. Reduced quality control turnaround time 40% by streamlining specifications and product disposition process.
Managed departments of 2 to 110 employees, the latter with a $7 million (1989) budget.
Designed quality and regulatory systems complying with current Good Manufacturing Practice (cGMP) regulations for two companies.
Kept an $8 million/year product on the market by negotiating with an FDA investigator and a distributor's QA and RA staffs during a recall and inspection. Received only one Observation on the FDA 483 after a 7-day inspection.
Wrote a successful pre-market notification, 510(k), for an in vitro diagnostic device.
Promoted the four-fold growth of a product line by: Anticipating and filling need for superior professional leadership in Quality Control. Balancing manufacturing efficiency and customer needs in negotiating a process to set expiration dates for reagents. Evaluating quality control and assurance personnel, facility, equipment and documentation requirements for expansion operations in Puerto Rico plant.
Initiated Total Quality Management and ISO 9001 Registration processes.
Wrote IVD Stability Study guidelines as member of Health Industry Manufacturer’s Association (HIMA) taskforce.
Led a team developing software control and validation requirements
GMP Compliance, including the Quality System Regulation for In Vitro Diagnostics and the Guidelines for Active Pharmaceutical Ingredients, Training, Auditing, Document Control, Biologics Responsible Head
In Vitro Diagnostic Reagent and Instrument Design Control and Quality Control
ISO 9001 Management Representative and Total Quality Management Implementer
Regulatory Submissions, Customer and Regulatory Communications.
