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Expert has performed validation of aseptic processes including technologies such as blow-fill-seal, high-speed automated liquid and powder filling lines, lyophilization, barrier and isolation technology, and bulk pharmaceutical and biological processes. Expert has developed an airflow visualization procedure to assist the design of planned and unplanned interventions during aseptic processing. Using this procedure, he has been able to modify HVAC and air directional systems to address process simulation (media fill) failures.

Expert has developed and executed cleaning validation master plans for multi-product parenteral facilities and solid dosage manufacturing facilities. He has recently developed a cleaning validation master plan for a manufacturer of oligonucleotides using solid phase reaction vessels. In the execution of these plans, Expert has aided clients in the development and validation of sampling procedures and analytical methods.

Expert routinely conducts cGMP audits and pre-approval inspections at clients' manufacturing facilities and at third party manufacturers. These inspections evaluate all aspects of pharmaceutical manufacturing and control, including quality systems, laboratories, material handling systems, facilities, equipment, and documentation systems. In addition to providing a detailed list of observations, Expert provides suggested remedies to address these observations.

Expert has provided guidance to clients on the validation of manufacturing processes for numerous types of drug products including liquid parenteral products, lyophilized parenteral products, solid dosage forms, metered-dose inhalers, and sterile suspensions. He has worked directly with filter manufacturers on behalf of clients for the validation of sterile filtration processes of numerous products.

Expert routinely conducts cGMP audits and pre-approval inspections at clients' manufacturing facilities and at third-party manufacturers to ensure continued compliance with FDA regulations and the accuracy of information submitted to the FDA as part of an ANDA or NDA. These inspections evaluate all aspects of pharmaceutical manufacturing and control, including quality systems, laboratories, material handling systems, facilities, equipment, and documentation systems. In addition to providing a detailed list of observations, Expert provides suggested remedies to address these observations.

Expert has provided guidance to clients on the validation of manufacturing processes for numerous types of drug products including liquid parenteral products, lyophilized parenteral products, solid dosage forms, metered-dose inhalers, and sterile suspensions. This guidance incorporates both "good science" and compliance to the FDA guidance on process validation. He has worked directly with filter manufacturers on behalf of clients for the validation of sterile filtration processes of numerous products.

Expert uses HACCP in the development of process validation protocols and in conjunction with "root cause analysis" for failure investigation. As a pharmaceutical quality assurance professional for more than 30 years, he has conducted both Out of Specification (OOS) and manufacturing deviation investigation and prepared reports to identify the root cause of failures and prevent their future occurrence. Expert has developed training programs for personnel involved in HACCP and failure analysis and has provided direct training for clients involved in this task.

Expert has provided guidance to clients on the validation of manufacturing processes for numerous types of drug products including tablets, coated tablets, capsules, creams, ointments, and suspensions.

Expert has assisted in the design of pharmaceutical manufacturing facilities and processing systems for the manufacture of parenteral products. He has also conducted HACCP evaluations of both solid dosage and liquid drug products. He brings both practical production and quality assurance perspectives to the evaluation of drug processing facilities and systems.

Expert has designed validation protocols for the validation and continued monitoring of systems used to generate "purified water" including carbon filters, water softeners, reverse osmosis (RO) systems, deionized water (DI) systems, and ultra-filtration systems. He has also designed validation protocols for the validation and continued monitoring of systems used to generate water for injection (WFI) and pure steam. The scale and complexity of these systems has ranged from laboratory scale to large manufacturing plant systems with a multiple effect still, several storage tanks, and multiple recirculating loops.

Expert has performed validation of aseptic processes including technologies such as blow-fill-seal, high-speed automated liquid and powder filling lines, lyophilization, barrier and isolation technology, and bulk pharmaceutical and biological processes. Expert has developed an airflow visualization procedure to assist the design of planned and unplanned interventions during aseptic processing. Using this procedure, he has been able to modify HVAC and air directional systems to address process simulation (media fill) failures.


Expert has advised clients in the development, manufacture and control of injectable drugs. Expert has experience with pre-filled syringes, cartridges, vials, ampoules, lyophilized products and aseptically filled powders for injection.

Expert has developed training programs for inspectors responsible for the 100% inspection of parenteral products for foreign particulate matter.

Expert has developed facility validation master plans and cleaning validation master plans.He has performed HACCP for aseptic processes for both microbial and particulate matter contamination. Expert has managed the technology transfer of several parenteral and solid dosage products between companies and at inter-company sites.He has developed a cleaning validation master plan for equipment used to synthesize and purify oligonucleotides. Expert managed the validation startup of numerous automated filling lines for the manufacture of parenteral products.