Breeding Reining horses
JOANNE SCHLOSSIN
Ivanhoe,TX
Summary
Accomplished Consumer Safety Officer at the FDA with expertise in regulatory compliance and inspections. Proven track record in leading complex audits and training junior staff. Adept at liaising with stakeholders and ensuring adherence to GCP/GLP standards, enhancing operational efficiency and regulatory readiness.
Overview
32
32
years of professional experience
2
2
Certification
Work History
Consumer Safety Officer
Food and Drug Administration (FDA)
Dallas, NY
01.2009 - 01.2026
- Executed inspectional assignments with minimal guidance under new regulations, ensuring compliance amid media scrutiny.
- Investigated practices for adherence to GCP regulations and the Food, Drug, and Cosmetic Act.
- Directed complex domestic and international inspections within bioresearch monitoring programs.
- Evaluated findings for compliance, recommending and implementing follow-up actions.
- Reviewed violation reports, assessing evidence sufficiency to support regulatory actions and ensure compliance.
- Coordinated with foreign governments to establish inspection procedures, enhancing effectiveness in addressing bioresearch monitoring issues.
- Served as an expert advisor, providing consultative services for BIMO programs to stakeholders.
- Provided leadership and on-the-job training to junior staff on technical and policy matters.
Clinical Research Associate
Roswell Park Cancer Institute
Buffalo, NY
06.2008 - 01.2009
- Managed research regulatory documents and facilitated the submission of new studies, amendments, continuing reviews, and all other study documentation to regulatory bodies.
- Monitored patient recruitment and retention for ongoing clinical studies.
- Collaborated with investigators to manage study timelines and deliverables.
Head of Quality Assurance Unit / Drug & Treatment Development
Roswell Park Cancer Institute
Buffalo, NY
01.1994 - 06.2008
- Evaluated documents submitted for FDA filing in support of clinical trials and facilitated successful FDA GLP inspections.
- Monitored preclinical research procedures for adherence to protocols, FDA regulations, and GCP/GLP requirements, ensuring compliance and integrity of studies.
- Managed the GLP Compliance Group, which audited approximately 60 GLP toxicokinetic, drug metabolism, pharmacokinetic, and dose formulation studies and their associated reports.
- Prepared audit reports, ensured timely responses, and assessed effectiveness of corrective actions to enhance compliance and quality assurance.
- Monitored contractor/vendor compliance with GLP requirements and maintained the GLP Master Schedule Sheet.
- Developed and delivered training on compliance, GCP, and GLP to enhance staff understanding and adherence to regulatory standards.
Education
Associate of Science (A.S.) - Veterinary Technology
SUNY Delhi
Delhi, NYDelhi, NY
Skills
- Regulatory compliance
- Inspections and investigations
- Quality assurance and auditing
- Biomedical compliance
- Clinical trials management
- Regulatory documentation
- Risk management
- Training and leadership
- Liaison and communication
Training
- Clinical Monitoring & Site Management
- Auditing Clinical Trials for GCP Compliance
- Good Laboratory Practices
- Basic Nonclinical Bioresearch Monitoring
- Basic Clinical Bioresearch Monitoring
- Advanced Clinical Bioresearch Monitoring
- Advanced Nonclinical Bioresearch Monitoring
- Basic Drug School
- Active Pharmaceutical Ingredient Manufacturing
- Process Validation of Drug Manufacturing Operations
- Industrial Sterilization for Drugs and Devices AMDUCA/Compounding Animal drugs
- Soft Skills for Professionals
- Postmarketing Adverse Drug Events and Risk Evaluation and Mitigation Strategies
References
References available upon request
Accomplishments
I was the lead investigator for two inspections which resulted in Official Action Indicated classifications of firms for noncompliance with GCPs:
• Untitled Letter dated 09/19/2022
• Warning Letter - dated 03/22/2023
I have been awarded multiple individual cash incentive and time-off awards for my dedication to ensuring the safety and health of the public.
• Untitled Letter dated 09/19/2022
• Warning Letter - dated 03/22/2023
I have been awarded multiple individual cash incentive and time-off awards for my dedication to ensuring the safety and health of the public.
Certification
FDA Certified Bioresearch Monitoring Program Investigator
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Quote
Education does not just come from a classroom
Interests
Timeline
Consumer Safety Officer
Food and Drug Administration (FDA)
01.2009 - 01.2026
Clinical Research Associate
Roswell Park Cancer Institute
06.2008 - 01.2009
Head of Quality Assurance Unit / Drug & Treatment Development
Roswell Park Cancer Institute
01.1994 - 06.2008
Associate of Science (A.S.) - Veterinary Technology
SUNY Delhi