Expert Details

Expert in Sterile Process Validation, Microbiology, Steam Sterilization, Aseptic Filling, Rapid Micro Methods

Expert ID: 731857 Illinois, USA

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Expert has over 25 years experience in various aseptic of sterile process validation. She has worked for Baxter, Fujisawa (now Astellas), Jordan Pharmaceuticals, Vectech Pharmaceutical Consultants and Excellent Pharma Consulting. This encompasses steam sterilization, aseptic filling, process validation, development of microbiology methods and the like. She served on the Advisory Panel for FDA on the new Aseptic Processing Guidance. Additionally, she has been very active in the Parenteral Drug Association (PDA), serving on the Scientific Advisory Board, Technical Book Advisory Board, and Chair of the Microbiology/Environmental Monitoring Interest Group for many years. She also chaired the PDA Midwest.

She has been involved in the development of many technical documents for industry including guidance on Rapid Micro Methods, Steam Sterilization, Aseptic Processing, and Environmental Monitoring.

She has served as an expert witness for some legal cases. She has also written expert reports for use in disputes between FDA and Industry; for product submissions in Europe; and the like.

Expert may consult nationally and internationally, and is also local to the following cities: Chicago, Illinois - Rockford, Illinois - Aurora, Illinois - Naperville, Illinois - Joliet, Illinois - Elgin, Illinois - South Bend, Indiana - Gary, Indiana - Milwaukee, Wisconsin - Madison, Wisconsin

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Education

Year Degree Subject Institution
Year: 1977 Degree: Master of Science Subject: Biology/Microbioloy Institution: Loyola Graduate School
Year: 1975 Degree: Bachelor of Arts Subject: Biology Institution: University of Missouri

Work History

Years Employer Title Department Responsibilities
Years: 2007 to Present Employer: Undisclosed Title: VIce President Department: Responsibilities: Oversee consulting services for all employees. Perform consulting in the areas of sterile process validation, steam sterilization, microbiology, aseptic processing, regulatory affairs, regulatory compliance.
Years: 2000 to 2007 Employer: Vectech Pharmaceutical Consultants, Inc. Title: Pharma Consultant Department: Responsibilities: Consulting services for all employees. Perform consulting in the areas of sterile process validation, steam sterilization, microbiology, aseptic processing, regulatory affairs, regulatory compliance. Founder of the Rapid Microbiology User's Group (RMUG)
Years: 1998 to 2000 Employer: Jordan Pharmaceuticals, Inc. Title: VP Technical Services and Regulatory Affairs Department: Responsibilities: Oversee all activities in regulatory affairs and technical services
Years: 1992 to 1998 Employer: Fujisawa USA, Inc. Title: Manager of Sterility Assurance and Regulatory Affairs Department: Responsibilities: Responsible for sterility assurance activities conducted at all sites. This includes steam sterilization, microbiology, aseptic processing and validation. Was responsible for the sterility assurance sections of regulatory submissions.

Performed regulatory submissions for ANDAs and NDAs.
Years: 1980 to 1992 Employer: Baxter Healthcare Title: Sr. Research Associate Department: Responsibilities: Development of microbiology methods. Oversite of manufacturing site activities in steam sterilization.

Career Accomplishments

Associations / Societies
• Member of the PDA / Parenteral Drug Society – Microbiology/Environmental Monitoring Interest Group Leader, Scientific Advisory Board (2000-2015), Program Advisory Board (periodically), Technical Book Advisory Board, Instructor at the Training and Research Institute (periodically), Participant in Many Task Forces
• Regulatory Affairs Professionals Society (RAPS)
• Rapid Microbiology Users Group (RMUG), founder and Editor in Chief from 2002 to 2007
• Institute of Validation Technology
• American Society for Quality (ASQ) – Certified Quality Engineer, Certified Quality Manager
Licenses / Certifications
American Society for Quality (ASQ) – Certified Quality Engineer, Certified Quality Manager
Professional Appointments
Scientific Advisory Board, Program Advisory Board, Technical Book Advisory Board, Instructor at the Training and Research Institute, Participant in Many Task Forces Regulatory Affairs Professionals Society (RAPS), Rapid Microbiology Users Group (RMUG), founder and Editor in Chief from Institute of Validation Technology,
Awards / Recognition
Industry Awards
PDA, Distinguished Author Awards for five different books
PDA, James Agalloco Award for Teaching at the PDA-Training and Research Institute
Patented a serum replacement for use in cell culture applications.
PDA, Service Award
Medical / Professional
COURSES PRESENTED:
- Validation of Rapid Microbiology Methods
- CpK Analysis
- Sterilizer Validation
- Environmental Monitoring for Aseptic Filling
- Development of Quality Systems
- Quality Engineering Course
- Quality Manager Training
- Microbiology Laboratory Training
- Microbiology for Non- Microbiologists
- Pharmaceutical Microbiology
-Comparability Protocols
- Systems Based Inspections
- Quality By Design
- Risk Based Manufacturing
- Auditing Facilities
- Sterile Process Validation Documentation
- Submissions
- Requirements for CMC development
- Product Development Requirements
- Training for FDA Drug School
- Sterile Fill Comparability
- PAT Submission-Rapid Microbiology
- Conducting Audits
- Microbial Data Deviations
-Rapid Sterility Testing, overview, validation and implementation
Publications and Patents Summary
123 publications

Additional Experience

Expert Witness Experience
In the Patent Infringement case, Expert wrote a 166 page decision. She referred to Expert 40 times in the decision: Expert convincingly testified (73), persuasively explained that, (86); it also demonstrates, consistent with the testimony of Expert (90) This testimony was convincing.(93) Expert credibly testified.(95)
Other Expert Witness Cases
• International Patent Court – Steam Sterilization Issue
• Sealed Cases, four class action suits for patient damages – Sterility Failure Issues
• Patent Infringement for Microbiological Software Trending Program
Training / Seminars
Expert has participated in numerous seminars and courses that contribute to her continuing education in pharmaceutical manufacturing processes and technology and safety. Some of which include Phil Crosby Defect Free Quality, Train the Trainer-GMPs, CpK Analysis, Statistical Packages for Regulatory Submissions, Six Sigma Quality, Statistical Analysis and Design of Studies, Quality Improvement, Aseptic Processing, Kaizen Quality, Environmental Monitoring, Chemistry Manufacturing and Controls, Parametric Release Section Development, Sterilization and Aseptic Filling Regulations, Submission of ANDAs, PAC SAS Training, Sterile Process Validation Documentation, PDA meetings (At least two/year) for to be Submitted in Product the last 18 years Applications, Computer Validation Auditing of Suppliers, Pharmaceutical Microbiology, Preparation for the CQE Exam, Sterilization Microbiology and Engineering, Preparation for the CQM Exam, D-value and z-value analysis, Environmental Control for Aseptic Processing, Sexual Harassment Training, Sterility Testing – USP, Ethics and Integrity Training, Microbiology Data Media Fills, GMPs, Current uses of Microbiological Testing during Advanced GMPs, Stability Studies
Other Relevant Experience
Expert has presented numerous seminars and lectures during her career in the pharmaceutical and healthcare industry.

Fields of Expertise

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