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FDA Approval, Regulatory and Compliance Process in Life Sciences for Program and Project Managers
AP-WLS      $149

FDA Approval, Regulatory and Compliance Process in Life Sciences for Program and Project Managers

About the instructorSandie Anderson

Sandie Anderson
As a management executive and proven innovator, Sandie Anderson has over 15 years experience as a Project and Portfolio Management leader, directing global drug development teams at Procter and Gamble, Alza Corporation (a Johnson and Johnson company), and Alexza Pharmaceuticals, shaping consumers’ interactions with products through expert leadership of early-stage to late-phase drug development programs. She has leveraged her background with pharmaceuticals, medical devices, and consumer products to develop and establish highly efficient systems, processes, and tools that led to multiple regulatory submissions and launches in Asia, Europe, and North America for products. Sandie, who has a passion for sharing her knowledge and mentoring others, has created learning interactive modules and training courses for team members and external partners aligned with FDA regulations and the drug-device development process. Sandie holds a PhD, MS, and BS degrees in Chemical Engineering

About the Workshop
Are you new to the pharmaceuticals and the biotech industry? Do you want to understand how you can translate your project and program management skills for drug and medical device development? Would you like to get a refresher on the medical device and drug development process? Would you like to learn more about cross-functional activities and how you can be more effective on your project team?

This course will provide an overview of pharmaceutical and medical device development from discovery and concept development to commercialization. We will review the high-level FDA requirements for drug and medical device development, regulatory compliance and approval, including elements of design controls. The course will also discuss the important interactions with the FDA and review groups, high-level cross-functional activities of the project team, including the role of project management, and key decisions required at each phase of drug development.

Structure of core teams, and the role of members and stakeholders
Overview of the FDA and review groups
Purpose and scope of the New Drug Application (NDA), Premarket Notification 510(K) and Premarket Approval (PMA)
Key FDA requirements, goals and outcomes for each phase of development
Purpose, design and scope of clinical trials at each phase of development
Introduction to Design Controls and their importance for medical devices
Cross-functional activities to support clinical trials and product development at each phase
Hands-on exercises, references, and tools for managing team interactions, decision-making, and driving your projects to success
PDUs: 8
Prerequisites: None
Delivery Methods:Instructor Led Classroom
Who Should Attend:
Project Managers who are new to pharmaceuticals and the biotech industry;
Executives who want a refresher on drug and medical device development;
Team members who want to better understand their role and their cross-functional interactions at each phase of development.


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