An analytical method is a process. The FDA process validation guidance applies to test methods, like all other processes in the pharmaceutical industry. Therefore, the laboratory or laboratories must demonstrate that a test method performs as intended through the method lifecycle.
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point".
Computer Intrusions are the cyber actor's portal to invade and burglarize homes and business across the nation and the threat will only continue to grow. The Financial Industry is faced with increasingly complex threats almost daily. These threats challenge traditional models of law enforcement, IT Management and Regulations. The SEC's Cyber Sweep Exam is not only another regulatory task for Financial Advisors but also serves as an outline to help your firm defend against the Cyber Criminal. Education, awareness and communication will help defend against the criminal element and protect our clients and our firms. The ongoing impact to financial firms is of critical importance to all. We hope this session will help educate you on your role in the defense process as well as review the regulatory landscape surrounding this topic.
Business Administration is often very generalized and even more often overlooked by project managers. This course is targeted to teach you the strategic and business administration concepts that are specific to project management.
Cyber-attacks and breaches dominate the media and are a significant focus of the government. Businesses and financial institutions are faced with the grim reality that a cyber-attack is inevitable. It's not a matter of if an attack will occur, only when. Entities large and small are under siege by sophisticated attacks that often are financially driven, draining accounts as effectively as they cut off the entities operations. Incident Response Plans today have to consider a myriad of possible attack methods to ensure Plans appropriately mitigate unique threats.
Grab a cup of coffee and join us to learn how to improve your KPI focus, and juice up virtually every facet of your organization's operations from marketing, to finance, to HR, to customer service and sales. Ensure your Performance Dashboards are crisp, attention grabbing and clearly identify significant performance trends. Know whether your business is meeting or exceeding its goals with your early warning system of leading and trailing performance indicators.
Join us and you can begin to develop a solid plan to move your company toward sales and use tax compliance. Experienced CPA and businessman, Miles Hutchinson, will review the basics of sales and use taxation with you and answer your questions. He will discuss legal developments in the area of taxation of internet sales. You will receive practical guidance to avoid penalties due to the ever increasing instances of audits by state taxing authorities.
Gain valuable insight into the complex issues of interstate sales and the obligations of out-of-state (foreign) sellers to collect the destination state’s taxes. Get up-to-date information about the retailing giants and their fights with the various states. Take a ring-side seat with an expert who will share the anticipated outcomes.
Miles Hutchinson, experienced CPA and financial analyst, will discuss the basic principles of FATCA, the affected businesses and individuals, the new and revised forms to effect compliance and provide you with simplifying charts and tables to help you determine your steps to full compliance. He will provide practical instructions and guidance for applying FATCA and will identify the key issues that will help you avoid potential penalties for noncompliance.
Meeting regulatory specifications is the minimum that a business needs to get done to operate in a market without falling in the risk of non-compliance. This type of requirements are analog to those required by the customers, and the Continual Improvement tools used for quality control are interchangeable. The idea of this webinar is to provide a visualization of regulatory requirements from a Continual Improvement angle. Ideas and examples of how Continual Improvement tools can be utilized to facilitate the management of regulatory issues will be provided.