DAY 1: Overview of FDA Approval and Compliance for Drug and Medical Device Development.
DAY 2: Resume Writing and Interviewing Techniques
About The Workshops:
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?
DAY 1:
Overview of FDA approval and compliance of drug development and Medical Devices
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.
DAY 2:
Resume writing and interviewing techniques
This workshop will focus on leveraging your personal project management knowledge, experience and skillsets for transitioning into the pharmaceutical, biotech and medical device industry. Special emphasis will be on understanding the various project management roles in the lifescience industry, and how to translate your unique project management strengths for optimum fit within a given function. Many examples of project management roles in the pharmaceutical, biotech, and medical device will be discussed, along with several case studies. The examples will cover biotechnology, pharmaceutical, medical device, contract research organization and government programs. The course will discuss the responsibilities and challenges with each role, the key skillsets to overcome those challenges and how they apply to project management. This course will be useful to anyone who desires to obtain practical resume writing techniques and interview tips to pursue lifescience project management opportunities. The class sessions will include interactive discussions and exercises.
| Hands on Exercises, tools and references to manage team interaction, decison making and driving your projects to success |
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