Best Practices For How To Structure And Write A Standard Operating Procedure (SOP)
Using a library of SOP’s to help organize and control your operations is just good business sense. This is particularly important in high-risk and critical operations, construction or industrial, where a mistake can be costly or result in catastrophic accidents or failures.One of the prime reasons to create an SOP is to predict and eliminate incidents, errors, accidents, failures, poor quality outcomes, etc..
Case Report Form Design, Strategy, and Standards
This webinar is an integrative learning experience, combining a comprehensive review of the good clinical practice and required elements for case report forms utilized in clinical research as data collection tools.The “GIGO” principle, “garbage in, garbage out”, can be applied to the data collection process in clinical trials. To avoid this issue, it’s important to be thorough in the evaluation of the data ..
Electronic Disclosure Under ERISA: Using Websites and Email to Meet ERISA Disclosure Requirements
The IRS and the Department of Labor allow electronic communications such as email and web-postings to satisfy ERISA disclosure requirements, but many administrators are not aware of the specific rules that apply to these disclosures. The Department of Labor and the IRS outline general requirements for electronic disclosure. First, the fiduciary must provide access instructions and the opportunity for a pape..
Telling FDA “No” During an Inspection: Refusals
The course covers the FDA’s authority to conduct an inspection and what happens when a firm makes a refusal. The webinar identifies what FDA considers a refusal and what it may or may not do as a result of the refusal. A firm should carefully consider what they will refuse and when they will do that. You will understand that human dynamics involved refusals and how to manage that aspect.The FDA is aut..
Going From Excel Pivot Tables To KPI Dashboards
IBM states that the data professional jobs projected to grow fastest are Business Intelligence (BI) Data Analytics and Data Visualization/Dashboards. The Demand for Data Analytics and BI Dashboard work alone is projected to grow by 44% over the next two years! 1. Source: IBM: The Quant Crunch, how the demand for data science skills is disrupting the job market.If you have a career that involves creating rep..
Harassment, Bullying and Discrimination in the Workplace
It covers all aspects of harassment, abusive behaviour, bullying and discrimination in the workplace. There are many examples of subtle abuses as well as discussion about the more obvious ones. Today’s climate, thanks in part to the #Me-too movement will also be discussed. Participants will learn about Quid Pro Quo and the meaning of hostile work environment. We will bust some common myths and offer remedie..
How to Improve Your Leadership Style
Before you start any journey you need to be certain of your “starting point” and then plan the best route to reach your destination. We will discuss basic behaviors and styles of leadership so you can figure out where you fit now. Then we will explore the necessary characteristics for becoming a great leader.Next, we will examine exactly how we become the way we are now, why we act the way we do, and how we..
How to prepare a PPE Assessment in accordance with OSHA Requirements
Personal Protective Equipment (PPE) is one of the mainstay elements in most safety programs. The problem is that it typically receives minimal attention from persons responsible for safety management. Buying your PPE out of a catalog or from the lowest cost provider are indications of deficiency in the process. OSHA recognizes that PPE is important, and has a small but significant requirement the employers ..
Medical Device Regulations in the MENA region
This seminar will provide an essential overview of the key areas of requirements for product approvals for medical devices in the Middle East and North Africa. The programme will cover the regulatory requirements and developments in the individual countries such as Algeria, Bahrain, Egypt, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Palestine, Saudi Arabia, Sudan, Syria, Tunisia, UAE, and Yem..
Responding to EEOC Discrimination Charges
In Fiscal Year 2017, The Equal Employment Opportunity Commission received 84,254 discrimination cases. Think about it, we have 200 work days a year – so this equates to over 400 a day and 52 every hour. Sheer numbers indicate that it’s just a matter of time before a discrimination charge crosses your desk. Get the information you need NOW to be prepared.Your first reaction to receiving a charge of discrimin..
Earned Income Tax Credit
The earned income tax credit is a great credit for lower-income individuals. Even for higher net worth individuals, during years of high capital investments with the combination of 100% bonus depreciation, the individual may have lower income than normal and qualify for the earned income tax credit. With this in mind, it’s a great idea to be aware of the credit and how it is calculated since there is a grea..
Human Error Reductions in Manufacturing Floor
Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occ..
Managing The Audit Function In A Global Company
Whether your company is small or large each should have at least one independent yet experienced individual or department that can be relied on to resolve issues from these and other perspectives: quality assurance, regulatory affairs, and corporate risk management. While companies rely on audits to remain in compliance everyone is eventually faced with a complex issue that requires examination from an..
Risk Management Planning In The EU
In 2012 the European Medicines Agency (EMA) published Module V - a Guideline on Risk Management Systems as part of its Good Pharmacovigilance Practices. A significant update to the guidance was then published in In March 2017 with the aim of further clarifying the activities on which a risk management plan should focus to ensure optimal health promotion and protection based on risk-proportionate planning of..
How To Increase Revenue With Sphere Of Influence Marketing
Leveraging your sphere of influence is critical to the success of your company. Yet many companies fail to market to their SOI. This can result in lost revenue for the company that will make it hard to compete, let alone thrive.This presentation will identify what SOI Marketing is. Who you consider as your SOI. What foundation you will need to lay in order to market to your SOI properly. When you should mar..