The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA also expects a post-production risk management program to be implemented. FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard.One of the techniques described in ISO 14971 is Hazard Analysis. This is the most powerful of the risk management techniques becau..
If an employer has exhausted all the necessary steps to help the employee improve his or her work performance – and those steps are not working – it may be time to terminate the employee.Terminating an employee is not only stressful for the employee losing a job, but also for the employer. There are legal, ethical steps to take when you terminate an employee. The company must ensure its actions are ab..
This session will provide some insight into current trends in cybersecurity threats to medical devices and how to follow industry best practices to prevent and/or mitigate these threats. Cybersecurity is a serious concern for medical device safety and effectiveness. Without protection, software running on a medical device could cause severe injury or death to a patient.There are many forms of cybersecurity ..
There are many different types of microbial contamination that can occur in pharmaceutical manufacturing. Some of the sources include water, raw materials, excipients, in-process materials and samples, the manufacturing process, the product itself, the environment, and the like. As such, there is no one size fits all investigation. Microbiological testing covers a wide range of products, processes, and envi..
Business writing is best when it is spare and clear, precise, and concise. This session is designed to give practical and useful advice and tips on how to tighten up the language and organize the content into a logical, convincing read. Attendees don’t have to be English majors or literature students. The aim is to improve the readability of your written words.Learning ObjectivesEliminate puffy and ambiguou..
Missteps in handling sensitive employee issues could result in your organization writing a check with a lot of zeros on it. How companies investigate potential misconduct can affect the company’s reputation as well as its bottom line. Cultural and generational diversity is changing the landscape of the US workforce. That diversity can become fuel for all types of litigation. Understa..
Generally Accepted Accounting Principles Update: Revenue Recognition, Lease Capitalization, CECL, And Not-For-Profit Accounting
Much of the change in GAAP in recent years is the result of a collaboration between the Financial Accounting Standards Board (FASB) and the International Accounting Standards Board (IASB) to bring the US and international accounting principles closer together. At some point, both groups decided they were as close as they would be likely to get on several key concepts—revenue recognition, lease capitalizatio..
Studies show most people spend about 50% of their work time writing and answering emails, substantiating the fact that email is an indispensable part of the workday. Processing email can be tedious, boring, and often mind-numbing yet writing and responding to emails with speed and acumen is pivotal to your success.In this day we spend together, you will learn how to:Survive the email avalanche that dumps in..
Microsoft Outlook can be a powerful partner in your quest to improve your delegation skills and the need to have employees finish assignments on time. Combine the power of Outlook, which everyone opens daily, with this instruction and delegation will become part of your natural workflow.The training is hands-on as attendees are encouraged to use two screens or be able to toggle back and forth between the in..
The goal of leadership is to motivate employees to give their personal best on a regular basis. An employees personal best is a gift of discretionary effort. Discretionary effort is a gift because employees make a decision on a daily basis whether or not to give extra effort, energy, and add value to the task they are completing. Discretionary effort is the difference between what an employee does to get a ..
Our world is complex and keeping on top of tasks, assignments, appointments, and meetings are challenging. For decades people who wanted to be efficient and keep on top of assignments used paper to-do lists, tickler files, calendars, and notebooks. Datebook organizers were revolutionary and widely used until the emergence of digital products. Microsoft Outlook has emerged as one of the best digital products..
If your workload has increased, your stress is up, and you need new ideas to “get it all done,” you’ll be amazed as you learn simple Outlook tricks that make handling your heavy workload relatively easy.In this webinar, you’ll learn the power of disposing of minor details and focusing on high “A” tasks that:Advance your careerMake it possible for you to deliver what you promised when you promised itPermit y..
If you want to catapult your career in addition to leaving work on time, sign up for this webinar. You will benefit professionally as you use Microsoft Outlook features to:Finish projects on timeRemember all assignmentsNever miss a deadlineNever miss a meetingYou will be recognized for your individual responsibility and accountability, catapulting your career.Learning ObjectivesLearning objectives for Leave..
A partner is valuable in any endeavor but especially in such a complex issue as productivity. You need a partner to keep you on track when interrupted, when distracted by miscellaneous thoughts that pop in your head, and when you have concentrated, taken a break, and need to get back on track. This is a “must-attend” and “don’t miss” webinar for attorneys who want to sharpen their work habits, prioritize fo..
If you are a pro at using email and using the calendar for appointments and meetings and you want to expand your use of the tool, this webinar is for you. Microsoft Outlook will become your partner in productivity when you discover the hidden features taught. This webinar covers productivity, not just from a technology viewpoint, but from a time management perspective. If you want to be productive, you need..