Jeanne Moldenhauer, M.S. - Microbiology Specialist

Qualifications

Jeanne Moldenhauer is a senior quality assurance/regulatory affairs professional with extensive background in the development and management of a variety of sterilization and validation processes in the healthcare industry. She has extensive practical background in both the manufacturing facilities and corporate operations. Jeanne has a proven track record of successful NDA, sNDA, ANDA, and DMF submissions to FDA. This has included an extensive background in CMC development for drugs, and special expertise in sterile process validation documentation. She also has extensive background in the rehabilitation of companies with negative FDA findings, restoring them to compliance. Additionally, she has substantial experience in assessing and validating laboratory and production facilities where solutions were needed for regulatory purposes. She is a Certified Quality Engineer (CQE) and Certified Quality Manager (CQM) (through the American Society for Quality). Jeanne has expertise in utilizing information technology to achieve results in quality improvement and cost savings. She is a Scientific Advisory Board, Program Advisory Board and Technical Book Advisory Board member and Interest Group Leader for the Parenteral Drug Association (PDA). Jeanne has also served on advisory committees for rapid methods, aseptic processing and sterilization for FDA. She is a frequent speaker and trainer for a variety of topics within the pharmaceutical and biotechnology industries. She serves on Scientific Advisory Boards for several companies in the area of rapid microbiology.

Work History

	Present	Senior Consultant - Microbiology Specialist	D.H. Gold Associates, Inc.
		Expertise in quality control and quality assurance requirements.  Highly experienced with preparation for and management of FDA  inspections.
		Vice President, Regulatory Affairs & Technical Services	Jordan Pharmaceuticals, Inc.
		As Vice President of Regulatory Affairs and Technical Services at Jordan Pharmaceuticals, Inc., Jeanne developed and implemented a technical services department, which included validation, calibration, a microbiology department and QC Microbiology. She successfully staffed all departments, and implemented policies and procedures that were subsequently approved by the FDA. Jeanne was instrumental in resolving 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. Additionally, Jeanne developed and implemented Jordan’s regulatory affairs and compliance departments, and created ANDA and NDA templates to be used for regulatory submissions. Finally, Jeanne developed and implemented a Regulatory Affairs department, which she staffed and trained.
		Senior Manager, Regulatory Affairs/Sterility Assurance & Manager, Sterility Assurance	Fujisawa USA, Inc.
		At Fujisawa, USA, Inc., Jeanne 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. She was a 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. Jeanne managed the submission of numerous NDA and ANDA products that were successfully approved by FDA. She also was responsible for the on-going maintenance of these submissions. She was also responsible for the development, submission and maintenance of numerous Drug Master Files. Jeanne developed and standardized regulatory documents to support sterile process validation for drug product applications to the FDA. In addition, she assessed the validation statistics of domestic and foreign facilities for process validation and regulatory liability risk. She trained audit teams, identified deficiencies, and determined necessary requirements within established timelines. While at Fujisawa, Jeanne developed a validation strategy to meet FDA requirements for the software used for the microprocessor control of sterilizers. She designed and conducted training for the software manufacturer’s employees on validation procedures and applicable regulatory requirements. Finally, Jeanne 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.
		Senior Research Associate	Baxter Healthcare
		As a Senior Research Associate for Baxter Healthcare, Jeanne developed an action plan to disprove the FDA determination that a method used for thermal death time testing of a drug was not appropriate. She 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. Jeanne also developed a lab design for Baxter and coordinated the building, stocking, validation and implementation of the laboratory. She participated on multiple project teams which developed better strategies for how and when testing should be performed. Additionally, Jeanne developed and validated microbiological methods for more than 50 different “difficult to validate” drugs, resulting in FDA approval on all.

Education

		Bachelor of Arts in Biology	University of Missouri
		Master of Science in Biology	Loyola University

Professional Associations

To further develop her awareness of technological developments within the pharmaceutical industry, Jeanne Moldenhauer participates in the following professional associations:

• Member of the PDA / Parenteral Drug Society – Microbiology/Environmental Monitoring Interest Group Leader, 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 2002 to 2007
• Institute of Validation Technology
• American Society for Quality (ASQ) – Certified Quality Engineer, Certified Quality Manager

 

 

Home | The Consulting Team | Consulting Services | Contact DHG | Why Choose DHG? | Our Success Stories | DHG Compliance Training | 483 Recovery

Questions or comments: dhg@dhgoldassociates.com Copyright © 2011 D.H. Gold Associates, Inc.