Medical Devices by their very nature must be safe for human use and must meet the requirements for which they have been designed. The process which identifies the risks associated with a medical device that could make the device unsafe or not function as intended is called Risk/Hazard Analysis.21 CFR Section 820 requires that comprehensive risk analysis be performed as part of the medical device regulatory ..
This webinar provides an overview of the various segments of an organization’s supply chains. Supply chain leaders must have an understanding of the objectives, goals, activities, and contribution of each part of a supply chain in order to successfully identify, restructure, manage, and control an organization’s many supply chains.Participants will discuss customer segmentation, customer demand, forecasting..
It is necessary to ensure that the hazards of all chemicals produced or imported are transmitted to employers and employees. The transmittal of information is to be accomplished by means of comprehensive hazard communication programs, which are to include container labeling and other forms of warning, safety data sheets, and employee training. This occupational safety and health standard is intended to addr..
For many people, the words “risk management” mean safety, workers comp, and insurance. There are also but HR Risk Management is much more than that - there are many HR risks that organizations need to handle to stay compliant and thrive. Risk management can be identified in nearly every aspect of a company. From the moment a candidate is interviewed for a position to when one exits the company, everything i..
FDA requires that all computer systems used to produce, manage, and report data for “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on computer systems that are validated and subject to inspection and audit. As a “GxP” system, following Good Manufacturing, Laboratory, and Clinical Practices..
Creating a positive culture of acceptance and inclusion includes understanding how to tap into the hidden power of employee's differences and create a work environment where everyone thrives. Diversity can be the root of conflict in the workplace if not managed and when conflicts go unresolved, animosity and distrust can build up on teams.Diverse organizations and teams can yield innovative results, however..
As the saying goes - If it isn’t documented, it didn’t happen! Documentation is essential for many legal issues, disputes, audits, meetings, and decision making, to name a few. Perhaps nowhere is it more critical than when documenting your investigation. Your documentation memoralizes the entire investigation, it minimizes confusion, corroborates stories and evidence, demonstrates patterns of behavior and s..
This course will help attendees understand the fundamental change control steps and processes. It will focus on change proposals, assessments, execution, and final implementation. The importance of proper planning, critical thinking skills, and coordination of all change activities will also be discussed.Learning ObjectiveIdentify what constitutes a changeLearn how to properly categorize a changeDemonstrate..
This course will look at the most common mistakes made on a Form 1065. When preparing a partnership tax return, this course will give you the confidence that you are correctly identifying major IRS audit issues and potential pitfalls that you can find with clients. We will look at several more advanced Form 1065 issues as well to help you tackle any Form 1065 that comes your way!Areas Covered Understand com..
One of the most basic analytical and underwriting tools a banker must have is the ability to determine whether a borrower can repay its loans based on the financial information available. Financial organizations extend credit to borrowers when the borrowers show the ability to repay the loans extended. Ideally, a request for a five-year loan should be supported by a 5-year cash flow projection. Learn key as..
This course will look at the top 10 issues small businesses face when undergoing an IRS audit. It will take a look at the audit from three perspectives, The clientThe practitioners andAn IRS auditor We look at these common issues along with ways to maneuver around the issues when the IRS brings them up. After this webinar, you should have a better grasp on helping your client through the most common types o..
Interpersonal communication skills are essential workplace skills. Communication - how what, and when can be a significant hurdle to convey during stressful times, and even more critical during chaos, crisis, and uncertainty. How do you ensure that you are delivering your key messages in a way that can be heard and understood by your team as you move forward through these uncertain times?Interpersonal commu..
One of the first steps in any procurement process is the creation of a bidders list or those vendors thought suitable and responsive to the commodity or services being procured. This program will help you solicit vendors for an RFP procurement.The RFP process itself will also be explored. The Request for Proposal process is often thought daunting and terrifying to the uninitiated who are assigned this..
It is important for managers and supervisors to understand the importance of documentation regarded their represented employees. It is critical for them to understand the impact and depth that documentation has on multiple areas of the workplace and operation of the business. One Key area of impact is the just cause standard and how the failure to properly document will result in the costly loss of grievanc..
Ms. Nash-Hoff’s presentation will provide information on how to use the new technologies of automation, robotics, Artificial Intelligence, Additive Manufacturing and Industrial Internet of Things to solve the shortage of skilled workers. She will cover whether or not to acquire the equipment in-house or whether to use vendors that have one of more of these technologies already in use. She will give examples..