Overview: By attending this seminar, you will be able to: Communicate more effectively in all media - verbal, written, and electronic modes Refine interpersonal skills as they relate to dealing with diverse personal perspectives, attitudes, and motivational techniques Develop and utilize task schedules Demonstrate effective management of all resources (people, tools, and budgets) Apply techniques for scoping programs/projects (resource needs,...

Course "Regulatory Affairs aspects of clinical trials and clinical Product Development in the EU" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: The main document from a regulatory perspective in the development of a medicinal product is the regulatory plan. In this Seminar it is explained how to write the regulatory plan, and which aspects to consider....

Course "Applying U.S. FDA Laws and Regulations to Each Phase of Total Product Life Cycle (TPLC)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This workshop style training course is supported by comprehensive knowledge of U.S. FDA laws and regulations and 30 year of extensive experience working within in the U.S. FDA regulated industries. In these 2 da...

Overview: This two day seminar will provide the foundation for the application, concepts and theories of clinical research. Within the two days, attendees will learn about the historical evolution of research, current regulations and guidelines including the Common Rule, FDA regulations and HIPAA. We will discuss site and study staff responsibilities in the conduct and reporting of research, types of studies and the regulatory requirements tha...

Overview: In keeping with the book published by McGraw Hill, what key steps do you want to take TODAY to address your effectiveness with: Managing a team Customer service Communication Facilitating change Removing troublemakers Managing your boss Clashes between two teams Managing performance Budgeting Taking a team from any of three stages to peak performance Managing a remote team or teams effectively Why should you attend? Would you like yo...

Course "Mastering the HIPAA Privacy, Security, and Breach Notification Rules: Coping with Rule Changes, Managing Incidents, Preparing for Audits, and Avoiding Penalties" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This session is designed to provide intensive, two-day training in HIPAA compliance, including what's new in the regulations, what's chang...

Course "Statistical Process Control & Process Capability" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This course teaches participants the fundamental concepts and methods needed to establish effective control charts and estimate process capability. In addition to learning traditional control charts (e.g. xbar, r/s), participants will be exposed...

Overview: We will be discussing the history and evolution of HIPAA Privacy/Security and the major points you need to understand to proactively protect your practice or business from the imminent federal auditing process: Specific areas covered will be: HIPAA now has teeth and funding - a background Be proactive NOT reactive - importance of this based on real life experiences What is involved in a HIPAA audit - from real life events Patients su...

Overview: Does your Complaint Management system provide value to your company? It does if your company handles complaints efficiently and effectively - taking them through the reporting, classification, investigation, corrective action, and design change phases. Your system is effective if it recognizes the requirements to report to regulatory agencies (such as FDA, the EU, and Health Canada) and ensures you make the reports on time. An integr...

Overview: A management system, by definition, is a process by which a function or functions are carried out in an organization by a series of hierarchal documents that are prescriptive, and set a particular path on which the organization manages its day-to-day operations. A management system can be for one function, but more often than not, it incorporates many functions. Functions like accounting, engineering, banking, etc. have their own man...