Project Management is defined as the planning and organization of an organization's resources in order to move a specific task, event or duty toward completion. However, Validation of Computerized Systems has a very specific set of tasks that are often mismanaged, resulting in missed deadlines, increased costs, and regulatory risk, and missed times to market for a company's product.
This webinar will examine the training that FDA inspectors receive on five regulations for inspecting medical device firms.It will present the specific guidance FDA inspectors receive for each of the regulations.
Importing FDA regulated products requires careful planning before you even start. Registration, product compliance, record and data submission must be exactly correct, or else, FDA's entry requirements with detain your product. Some mistakes are common, others reflect a lack of understanding of how FDA and Customs and Border Protection (CBP) operate a joint program.
The Value Proposition Canvas was created by Alexander Osterwalder of "Business Model Canvas fame". Its goal is to help business builders to be very clear about who a business is for and how it delivers value to them.
Every biopharmaceutical company has SOPs, and new staff members are told that the company "has to have them" and that each employee "has to follow them". But why do there have to be SOPs and why must we follow them as written? And how can we do this effectively?
This webinar describes the SharePoint Framework for Microsoft SharePoint Online. It is not addressed to a specific industry, as the technology presented in the course of this webinar can be applied to multiple domains.
What is a risky decision? How do you size up a risk's impact? How do you hold reckless risk-takers accountable?
Most managers and executives cannot answer these tough questions even though risk management is a key aspect of every manager's job. Universally, decision-makers are inadequately trained on how to deal with risk, so most major risks go undetected.
Bjarte Bogsnes, Chairman Beyond Budgeting Roundtable, has been heading up Beyond Budgeting implementation in two large international companies. More than twenty years of experience has given him deep theoretical and practical insights into this adaptive management model.