OVERVIEW This Computer System Validation Training will explore proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Today, the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements and companies must update their systems and processes to maintain compliance. Many companies outsou...

OVERVIEW Corruption is no longer a viable option for businesses engaged in international commerce. A number of laws, such as the US Foreign Corrupt Practices Act (FCPA), the UK Bribery Act, and international conventions, including the UN Convention against Corruption call for significant limits on the ways that businesses can solicit and conduct their business transactions. Substantial penalties can apply to businesses that fail to take proper...

OVERVIEW Participants will take away key insights about the mind and brain that will inspire new vision and possibilities and change the rules of the game for leadership and company success. Imagine you and your company operating in: A sustained “flow state” Unshakable (non-reactive) presence Positive stress-resilience Calm emotional grounding Spontaneous, creative leveraging of opportunities Deep listening to understand first and...

OVERVIEW When there is a need to make some change to an environment and/or resolve a problem, we must think about a project that could implement the necessary change and address the problem. But we can’t just run our project without proper justification. Justifying the project is a great mechanism to confirm that our project really addresses the need and paves the way for improvement. It helps us assure interested parties or stakeholders...

OVERVIEW This Computer System Validation Training will explore proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Today, the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements and companies must update their systems and processes to maintain compliance. Many companies outsou...

OVERVIEW "The Times They Are A-Changin” There are many practice opportunities for physicians to consider for the future. Will you remain in solo practice? Merge with others to form a bigger single specialty, multi-specialty group or ACO? Join a Foundation or University Affiliation? This workshop will present a balanced discussion of options and issues for physicians to consider before making these important practice decisions. This works...

OVERVIEW Bitcoins have gotten much more traction than early detractors and pundits expected. With that reality, what do banks need to do, if anything, to prepare for their existence and surprising acceptance? This session will present the fundamental workings of virtual currencies with an emphasis on bitcoin and the current state of the regulatory front. We will get your thinking caps energized as to how bankers might approach virtual currenci...

OVERVIEW Lookup formulas such as VLOOKUP allow you to return data from other locations in your spreadsheets without linking to individual worksheet cells. However, VLOOKUP can't always return the data that you need. In this webinar, Excel expert Dennis Taylor explores the nuances and limitations of VLOOKUP, helps you expand your use of this function, and then presents you with a handful of alternatives. WHY SHOULD YOU ATTEND Compare and contra...

OVERVIEW Don't spend another day worrying that you and your organization might end up in legal trouble from immigration law violations. The crucial information provided in this one-hour webinar will give you the knowledge and know-how needed to ensure your documentation is filled out appropriately, your records are kept correctly and your organization is legally compliant. WHY SHOULD YOU ATTEND Immigration law is one of the most pertinent and...

OVERVIEW This FDA compliance webinar will leave you with the information needed to create and maintain good documentation that meets FDA compliance standards. You will learn about what must be done and what must not be done. In addition, you’ll learn about the various computer system validation deliverables and how to document them through the entire process. FDA requires that all documentation related to GxP (GMP, GLC, and GCP) products...