Sterile Process Validation, Steam Sterilization, and Aseptic Processing Microbiology Pharmaceutical Expert

Expertise

• Regulatory affairs and quality assurance certified with ASQ.
• Over Twenty-five year's expertise in sterile process validation, steam sterilization and aseptic processing.
• Pharmaceutical microbiology, and chaired PDA's Microbiology and Environmental Monitoring Interest Group for over fifteen years.
• GMPs, data integrity, sterile process validation, steam sterilization, microbiology, environmental monitoring, regulatory updates, and conducting regulatory submissions.

Expert Witness Experience

• International patent dispute regarding steam sterilization.
• Wrongful death and Injury due to Sterility Failure Class Action Suites (several).
• Patent dispute sterilization of a drug product.

Experience

Undisclosed Company, Senior Consultant, 2007 - Present

• Serving as a Senior Quality and Regulatory and Microbiology Consultant for several companies.
• Consults on various areas of quality management and quality engineering, microbiology, rapid microbiology, sterility assurance, aseptic processing, risk assessment, compliance and regulatory submissions.
• Worked with compounding pharmacies for use to provide guidance on implementation of USP; and microbiology and aspetic support for regulatory submissions.
• Worked with regulatory submission in the device, drug and biologics areas.
• Conducted audit, for compliance, sterile processing and microbiology for data integrity.

Jordan Pharmaceuticals Inc, Elk Grove Village, IL, 1998 - 2000

Vice President Regulatory Affairs and Technical Services

• Developed and implemented a technical services department, which included validation, calibration, a microbiology department and QC Microbiology.
• Staffed all departments, and implemented policies and procedures that were subsequently approved by the FDA.
• Resolved regulatory issues, which had been acquired by Jordan Pharmaceuticals in the purchase of the company from its former owners, with the FDA District and Washington offices.
• Implemented Jordan's regulatory affairs and compliance departments, and created ANDA and NDA templates to be used for regulatory submissions.
• Implemented a Regulatory Affairs department and trained staff.

Fujisawa USA, 1992 - 1998

• Implemented and established the quality systems for documentation for the company's manufacturing plants, which included corporate specifications, requirements for documentation of equipment, normal operation, release criteria, validation, and handling of aberrant conditions.
• Member of the team responsible for analyzing, identifying and correcting a nationwide recall of over 500 batches of product due to "short-fill". The error was corrected quickly, which allowed for production to resume with minimum downtime, and the regulatory compliance issue with the FDA was resolved.
• Managed the submission of numerous NDA and ANDA products that were successfully approved by FDA. Responsible for the on-going maintenance of these submissions; responsible for the development, submission and maintenance of numerous Drug Master Files.
• Developed and standardized regulatory documents to support sterile process validation for drug product applications to the FDA. In addition, assessed the validation statistics of domestic and foreign facilities for process validation and regulatory liability risk.
• Trained audit teams, identified deficiencies, and determined necessary requirements within established timelines.
• Developed a validation strategy to meet FDA requirements for the software used for the microprocessor control of sterilizers.
• Designed and conducted training for the software manufacturer's employees on validation procedures and applicable regulatory requirements.
• Conducted an intense review of regulatory requirements and sterilization cycles, and devised a plan to standardize sterilization cycles. This standardization reduced sterilizer down time, resulting in a $13 million cost reduction per year.

Healthcare, Inc. , Round Lake, IL, 1992 - 2000

• Developed an action plan to disprove the FDA determination that a method used for thermal death time testing of a drug was not appropriate.
• Managed the investigation and prepared the final report for Baxter senior management and the FDA. The drug was subsequently approved, and the FDA praised the quality, accuracy and approach used in the report.
• Developed a lab design for Baxter and coordinated the building, stocking, validation and implementation of the laboratory.
• Participated on multiple project teams which developed better strategies for how and when testing should be performed. Additionally, developed and validated microbiological methods for more than 50 different "difficult to validate" drugs, resulting in FDA approval on all.

Legal Work

Bracco, Expert Witness

• Provided expert witness support for an international suit on sterilization development and validation winning the suit.

Baxter Healthcare, Senior Research Associate

• Developed an action plan for a FDA determination of product, prepared the final report for Baxter senior management and the FDA. The drug was subsequently approved, and the FDA praised the quality, accuracy and approach used in the report.
• Developed a lab design for Baxter and coordinated the building, stocking, validation and implementation of the laboratory.
• Participated on multiple project teams which developed better strategies for how and when testing should be performed.
• Validated and developed microbiological methods for more than 50 different "difficult to validate" drugs, resulting in FDA approval on all.

Educator

Seminars and lectures in the pharmaceutical and healthcare industry, course topics:

• Sterilization Microbiology
• Feasibility of Using Scan RDI for Biological
• B. coagulans resistance in various Parenteral solutions
• Risk Based Manufacturing
• Auditing Facilities
• Sterile Process Validation Documentation
• Requirements for CMC Development
• PAT Submission-Rapid Microbiology
• Rapid Sterility Testing, Overview, Validation and Implementation

Honors & Publications

Credentials

• Certified Quality Management from ASQ
• Certified Quality Engineer from ASQ

Academic and Professional Affiliations

• Parenteral Drug Association
• International Society of Pharmaceutical Engineers
• American Society of Quality
• Regulatory Affairs Professionals

Awards

• PDA, Distinguished Author Awards for five different books
• PDA, James Agalloco Award for Teaching at the PDA-Training and Research Institute
• PDA, Service Award

Publications and Patents

• Author (including international) of educational text books (training manuals, instruction booklets).with topics.
• 1 patent - serum replacement

Education

• M.S. Biology, Loyola University, Chicago, IL
• B.S. Biology, University of Missouri, Columbia, MO