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Showing posts with the label FDA Submissions

Means & Methods of Schedule Delay Analysis

Schedule delay analysis has evolved greatly over the past fifty or so years. Advances in computer technology, and especially the advent of, and advances in, personal computing have resulted numerous ways with which to address schedule delay claims. Unfortunately, many of these methods offer only facile solutions to complex problems.In this webinar we will briefly review the concepts of Critical Path Method (CPM) scheduling, and then apply the concept of the critical path to the various methods of schedule delay analysis. We will look at both modeled methods of analysis and observational methods. We will address the pros and cons of the various methods, the data necessary for their implementation of each method, and the current state of acceptability of each method. Finally, we will work some basic examples of each method, illustrating the major points of our discussion.  In this webinar expert speaker Fritz Marth will help attendees to develop understanding of Critical Path ...

FDA FSMA: Preventive Controls Food Safety Plan

"Food Safety Hazard Analysis and Risk-Based Preventive Controls Plan For Human & Animal Food " All food facilities registered with the United States Food and Drug Administration (FDA) must comply with the requirements under the Food Safety Modernization Act (FSMA) to develop and implement a Preventive Control Food Safety Plan that includes a Food Defense Plan. The plan must also include a hazard analysis, allergen analysis, factory profile, recall plan, supply chain controls, process preventive controls, sanitation preventive controls and other items. The plan must be reviewed and approved by a preventive controls qualified individual (PCQI) and it must be validated.  In this webinar expert speaker  John Ryan  will discuss the company’s responsibility under FSMA is to assure that the plan is implemented, verified and validated. Speaker will cover plan development of the preventive control food safety plan and the development of the food defense plan.  S...

HR 101 – Compliance You Need to Know

Employees are the lifeblood of most companies and they often determine whether companies thrive or whither on the vine. And as managers, leaders, and HR professionals we are expected to know and apply the alphabet soup of federal and state laws (ADA, FMLA, Title 7, EEOC, AA, etc…..) In this case, what you don’t know really can hurt you and as employers and managers we are expected to at least know the basics. Our goal with this webinar is to demystify and make sense out of the many pieces of the puzzle. HR 101 is just that – a 5000 foot view of the key HR components that you need to know. This webinar will be packed with information plus we provide a number of handouts that will provide additional guidance after the program. In this webinar expert speaker Wes Pruett will make it concise, understandable, and practical so that you have enough information to help keep you out of trouble and also the meaning of disparate treatment and adverse impact. A discussion of reasonable accom...

Navigating the Family and Medical Leave Act

The Family and Medical Leave Act is probably one of the most difficult leave laws to navigate.  Understanding the various terms, calculating the leave to which an employee is entitled, determining what benefits you must provide to employees while on leave can be a legal landmine. This presentation will walk you through this legal landmine and provide with the nuts and bolts of what the Family and Medical Leave Act.  FMLA leave for family of military personnel buy these reference materials and receive the information needed to guide you through the maze of family and medical leave laws. You will learn how these old and new rules interplay with each other and ensure that your policies and practices are in compliance.  In this webinar expert speaker Susan Fahey Desmond, will sort out all the different types of medical leaves, clarify the associating factors between them, and give you a solid toolbox of best practices for understanding leaves, using them safely...

2018 New W-4 Form and Beyond

The Internal Revenue Service (IRS) has finally released an updated Withholding Calculator which reflects changes under the new tax law. Dec of 2017 The Tax cuts and jobs act was passed and it was one of the most significant tax changes in sometime. This webinar will prepare the payroll professional to understand the changes to the form W-4 for 2018 and beyond because of tax reform. Form W-4 is a critical form that all companies have to obtain from employees. And the IRS has specific laws and how they should be handled plus these laws change and it is important to keep current. With the new tax regulations going into effect just recently, the Internal Revenue Service (IRS) is still working on revising the W-4 form to reflect some changes.The IRS has now released an updated form W-4 for 2018 . join our webinar if you need to make changes to your withholding for 2018. In this webinar expert speaker Dayna Reum will Review potential recent updates, discuss concerns around proper...

Performance Appraisals: What to Keep & What to Change

Performance appraisal: often called the “most dreaded management task”.  Organizations are struggling with the question: do we keep our performance appraisal system ? In this program, Judi helps you re-evaluate your performance appraisal system, taking it out of the past and bringing it into the present to enable employees to benefit from a more robust coaching and continuous feedback system. Without a successful performance appraisal process, organizations can fall into the trap of “carrying” poor performers & tacitly endorsing substandard work.  In this webinar expert speaker Judi Clements will shows you how to revamp your appraisal practices and turn performance discussions into valuable give-and-take conversations, minimizing defensive reactions and introduce the use of digital tools that take performance discussions into the new age.  Session Highlights:  Analyze what works & what doesn’t in the performance appraisal system  ...

Medical Device Change Control and FDA Submissions

This course is intended to provide an overview of 2 new  FDA draft guidance documents  that clarify when medical device and software manufacturers must file a 510(k) (premarket notification) for changes to an existing device and/or software integrated with a device. The FDA notes that while neither of these drafts specifically includes combination products, the general concepts may be helpful in determining whether changes to device constituent parts of combination products need a 510(k). The critical decision is whether a proposed change to a legally marketed medical device subject to premarket notification requirements is significant enough to require FDA review. This includes any major change or modification to the intended use of the device that could have an impact on patient safety and effectiveness. In this webinar expert speaker Carolyn Troiano will aid manufacturers of medical devices who intend to modify a 510(k)-cleared device or a preamendments device subject...