Training Doyens

OVERVIEW Since September 2009, the Centre for Devices and Radiological Health has been reviewing the operation of the 510(k) program and the way CDRH uses science in the decision making process. In August 2010, the 510(k) Working Group and the Task Force on the Utilization of Science in Regulatory Decision Making each released a preliminary report with a series of recommendations. Overall, industry has provided mostly a positive response but with exceptions. The proposals are more benign than many had feared. No radical change to the current process appears likely. Bottom line, FDA issued two comprehensive evaluations containing recommendations that address three key objectives of the agency’s public health mission as it relates to medical devices – foster device innovation, create a more predictable regulatory environment, and enhance device safety. 510 K Submission Process WHY SHOULD YOU ATTEND This webinar provides an overview of the premarket notification process an...

OVERVIEW Communication is a two-way process to exchange ideas. We communicate in order to elicit some type of response. Some examples of a response could be more knowledge, a specific action, or some type of emotion. Understanding the D.I.S.C. profile will help understand the four different personality type and how they like to receive information. Do you have a clear understanding of how to communicate with others? If you could exploit your communication style what would it mean to results at your company? How To Improve Communication Skills WHY SHOULD YOU ATTEND Did you know that … 70% of small to mid-size businesses claim communication is their primary problem. A business with 100 employees spends an average downtime of 17 hours a week clarifying communications. This translates in an annual cost of $528,443.00. Miscommunication can cost an organization 25% to 40% of its annual budget. More than 80% of projects are late, over budget, short ...

OVERVIEW Discussions, presentation, and webinars regarding HIPAAregulations are usually addressed from the perspective of what the regulations entail, the necessity of compliance with the regulations, and the consequences of wilful neglect or non-compliance.   This presentation addresses HIPAA regulations from a different perspective – from a personal perspective – from the perspective of the person in charge of moving an organization or facility toward full compliance with HIPAA.  The by-product of this presentation will be both an understanding of, and a detailed job description for, a position mandated in the regulations – the HIPAA Security/Privacy Officer. HIPAA Regulations WHY SHOULD YOU ATTEND The HIPAA regulations are numerous, complicated, often vague, and affect every person working in a healthcare facility.  Compliance with HIPAA will require a unique individual to lead the charge – an individual whose education, background, experience, a...

OVERVIEW Have you looked at how your company develops strategy lately? Is your organization poised to implement strategies that createvalue, generate growth and result in profits? Who thinks strategically in your firm? Strategy formation and strategic thinking have evolved; make sure your strategic thinking skills are keeping pace. You need to know the answers to these questions. Additionally you also need to know what tools still work and continue to be useful in the development of strategy and what new approaches might give your organization a kick-start to move to a new level of high performance. This course is designed to mesh the proven-by-practice strategies with new insights and ideas from a wide range of current strategic thinking. Managers learn by doing and gain a wider perspective of management practice through breakout sessions, practice exercises and case applications. Bring your strategic dilemmas to this program and get direction on up-to-date analytical and or...

OVERVIEW Learn the different skills of mentor, coach, and manager. Learn the role of a mentor, coach and manager in team engagement and employee loyalty. Successful career management by employees means accountability and getting formal and informal feedback. Talented human capital will be the prime ingredient of business success in the future. Organizational culture values mentorship and coaching and includes constructive and timely feedback. WHY SHOULD YOU ATTEND Managing employees and motivating them to achieve their best require a variety of skills. Understanding the difference in the roles of a mentor, a coach and a manager will help managing employees better. Learning how to effectively use different skill sets to engage employees is key to being a manager.  Managing your career using a mentor, coach and a good manager will provide you the feedback you need. Motivation Training Program AREAS COVERED Learn the different skills o...

OVERVIEW Microsoft's Outlook is an irreplaceable tool for countlessorganizations and a veritable legion of people around the globe—but it's not a beloved one by any stretch. Nobody actually enjoys sifting through a stuffed inbox or responding to meeting requests all day long; you want to open your inbox, do what you need to do, and get the heck out as fast as possible.  That's where these Outlook organizational best practices come in. Adopting the best practices will make diving into your inbox less painful—and far less time consuming. Microsoft Outlook Online WHY SHOULD YOU ATTEND Business owners CEO's / CFO's / CTO's Managers of all levels Anybody with large amounts of data Anybody who uses Word on a regular basis, and wants to be more efficient and productive Accountants Secretaries Admins Managers CPAs Controllers Financial Consultants IT Professionals Auditors Human Resource Personnel Bookkeepers Marketers Writers Peo...