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Does Anyone Care About SOX Anymore?
Many people feel that the task of documenting their company’s Sarbanes-Oxley controls has become routine and downright boring. However, the SOX documentation process remains one of the best ways for CFOs and CEOs to be comfortable in signing off documents that make them personally and criminally responsible for the accuracy and reliability of their public company's financial statements and the effectiveness..
DOL & New Regulations! Best Practices for 2019!
The regulations above are just a few of laws changed, revised or newly developed. Employers are impacted by a minimum of 8-26 regulations or more in 2018! Learn how you can manage the many laws that impact your organization by attending this webinar.Describe topic importance, how this can add value to the work style.Employers must arm themselves with the workplace regulations that will impact their organiza..
Domestic and Foreign Medical Device Regulatory/Reimbursement Strategies
In general, all commercial medical devices require regulatory approval, for obvious reasons. Of equal importance, is to have a reimbursement pathway in each country where the device sale is targeted. One must get a reimbursement assessment early--while still in the product design phase. One must understand how your device may or may not fit within current payment methodologies such as DRGs, resource-based r..
Drafting Document Retention Policies
The presentation reviews the basic approach of Information Governance and the importance of getting the relevant stakeholders at the table when drafting a document retention policy. We discuss the importance of document destruction and how to develop a policy that balances the interests of the various stakeholders.Areas CoveredInformation GovernanceObjectivesPolicies and ProceduresRecords Retention and Dest..
Drug or Cosmetic? Promoting Health Benefits in Personal Care Products
FDA has a history of avoiding discussion of popular issues and leaving the course of history to the imagination of the industry to push the boundaries of regulatory compliance. The unwillingness by FDA to address issues like “natural”, “probiotic”, “CBD” and other popular issues, creates an opportunity to add market potential, but it also creates hazards to avoid for FDA regulated products. Assuming that di..
Drug Product Performance, In Vivo: Bioavailability and Bioequivalence
Drug product performance, in vivo, is defined as the release of the drug substance from the drug product leading to the bioavailability of the drug. The evaluation of drug product performance relates bioavailability to the therapeutic response and adverse events. Bioavailability and bioequivalence studies are measurements of drug product performance and can be used to evaluate new drug formulations, changes..
Due Diligence Steps for Form 1099 Compliance
Form 1099-MISC compliance is a surprisingly complicated compliance requirement for businesses and accountants. The requirements are always changing, and answers are seldom clear-cut. This course will de-mystify some of the tricky areas relating to Form 1099-MISC, such as when 1099 should be issued and whether a worker is a contractor or an employee. The main focus of this presentation is on “box 7” (indepen..
E-Mailing, Texting, and the Use of Personal Devices by Health Care Professionals – HIPAA and Privacy Myths vs Reality
This informative webinar begins with the most basic of questions: Does the HIPAA Privacy Rule permit health care providers to use e-mail to discuss health issues and treatment with their patients?Find out the answer and examine how the privacy rules of HIPAA allow covered entities and health care providers to communicate electronically, such as through e-mail or texting, with their patients and with other h..
Early Warning Signs of Construction Claims & Disputes
It is axiomatic that claims and disputes on a project do not simply appear out of nowhere. Experience indicates that when a dispute occurs, there is normally a back story or history of events, decisions, lack of decisions, etc. that can be traced back from a few weeks to several years that gave rise to the dispute. It is these past events or decisions that are identified as the “early warning si..
Effective and Practical use of FMEA for Risk-Based Approach to Computer Systems Validation
Validation of computer systems is a regulatory requirement within the life sciences. "How much to validate" is one of the biggest challenges validation teams face. The struggle to balance time and available resources with compliance requirements often leads to insufficient testing and/or project overruns, which in turn can lead to significant regulatory and safety risks. One way to avoid these issues is to ..
Effective Communication Skills: It’s Not What You Say, But How You Say It!
Effective communication is about really listening to others without any blinders on, eliminating the gossip and rumor mill, reducing the causes of turnover by providing timely and appropriate recognition, leading employees through changes by transparency, correcting the poor performers by coaching them and setting the standards in highly adhered to on-boarding and training standards. All we have in common w..
Effective HR at Work: Creating a High-Performance Workplace
As Human Resources, we are always balancing a the tightrope between keeping the C-suite happy and effectively working with our employees. It is neither simple nor easy. Our jobs are a lot easier when we work in a culture of highly motivated employees who want to do their best every day. But how to reach that pinnacle? Motivating employees is difficult, but not impossible; using a few tried and true techni..
Effective Inventory Management
Inventory management is one of the key pillars of a successful business. While this statement would seem to go without saying, in real life effective inventory management is a very difficult objective because of all of the moving parts. Simply put, a robust and collaborative extended supply chain is required to meet the changing demands of this marketplace.Effective inventory management requires that global..
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..
Elements of Effectively Coaching Employees
Coaching is a process of helping another individual realize their inner potential, delivering fulfilment to both the individual and the related organization. Coaching in the workplace typically focuses on an improvement in individual performance against key performance indicators or job expectations but can also focus on career development and employee growth. Unfortunately, coaching is the part of a manage..