TrainSMART’s Senior Instructional Design Consultant has over 20 years designing, developing, and implementing training and training programs for pharmaceutical and medical device organizations – specifically compliance and SOP-related training. Her multi-faceted background in training, quality, compliance, electronic regulatory system implementation, and quality system management.
She utilizes a collaborative methodology to assess business issues and provide training programs with high impact and interaction.
Key Competencies
Key Experience
- Manager of Quality Assurance and Compliance, Documentation, and Training, for a Japanese global pharmaceutical organization
- Developed and implemented global electronic solutions for training and controlled documentation systems.
- Assisted in numerous rollouts of global electronic systems that support regulatory requirements
- Facilitated compliance training in global operations including experience with Japan, Europe, and Puerto Rico.
- Division Quality Assurance & Compliance Training Consultant for a major pharmaceutical organization
- Training Specialist and training coordinator for a major pharmaceutical organization
- OJT for major medical device organization
- Research, manufacturing, and laboratory technician for a major medical device organization
- Teaching Assistant
Design Experience
Experience in project managing, designing, developing, and implementing a multitude of instructional delivery methods including:
Core Strengths
- Project Manager
- Instructional Designer in a variety of delivery methods
- Process Mapping
- A clear understanding of the regulatory environment for pharmaceutical and medical devices
- Quality System Management
- Commanding facilitator
Philosophy
When working with clients, I strive to be a collaborative trusted partner. I focus on providing a client with a solution that meets their business and training need as well as work to provide a sustainable solution.
I remain involved in training organizations and continuously participate in forums, cohorts, certifications, and training programs in order to stay abreast of the most modern approaches, industry trends, and challenges. When working on a project, I utilize my experience and pool of colleagues to provide the best solutions/ recommendations and modern approaches.