This seminar will provide an overview of environmental monitoring investigations and tools to complete an investigation. Environmental monitoring is the method by which cleanrooms are known to maintain a certain level of cleanliness. The methods by which cleanrooms are monitored are through viable and non-viable testing. Through this testing, a room may demonstrate that it is out of control. This seminar wi..
The agencies that comprise the Federal Financial Institutions Examination Council (FFIEC) created the FFIEC Bank Secrecy Act/Anti-Money Laundering (BSA/AML) Examination Manual. These examination procedures apply to banks, savings and loan associations, savings associations, credit unions, and branches, agencies, and representative offices of foreign banks.Manual provides guidance to examiners for carrying o..
This webinar will overview the important critical content of these two revised documents to include the most important checklists that are contained in the Refuse to Accept Policy guidance that provides acceptability criteria for each 510(k) – Traditional, Abbreviated, and Special. The checklists clarify the content needed in traditional, special, and abbreviated 510(k) submissions to allow the FDA to condu..
Management of Accounts Receivable (AR) is one of the most measurable activities within an organization. Among the most widely used metrics of AR management success areDays Sales Outstanding (DSO) and the percent of the AR asset that is past due. While many believe these are flawed metrics, nobody outside the credit Department really cares; they just want a report on the actual measure achieved vs target and..
On May 31, 2019, the IRS released a draft of the 2020 W-4 form for the payroll and tax community to review. This webinar will prepare the payroll professional to understand the changes to the Form W-4 for 2020 and to review the recently released final of the 2020 W-4 Form. Before changes, the Form W-4 was a critical form that all companies have to obtain from employees and has had special processing require..
Annual Product Quality Review (APR) is an evaluation conducted annually to determine if there are any possible changes in the process or manufacturing of the pharmaceutical product or any change in the specifications of the product or any change in the manufacturing process. It is designed to minimize product defects and also the risks associated with the manufacturing of the pharmaceutical product.Areas Co..
This session will discuss how to prepare for the inspection, what to do during the inspection, and the close-out interview, and how to respond to the inspection. Also contained in this session will be the limits of FDA's scope during an inspection, including what documents you are not required to show them, and the permissibility of photographs and affidavits.Areas CoveredTypes of InspectionsPrepa..
What are the benefits to your company in the form of thousands of dollars saved? You will learn why workers' compensation carriers are willing to give you credit on your premiums that may cover the entire cost of auditing, bringing your program into compliance. Why downloading a program on the net could be really problematic.Areas CoveredOverview to determine if your program is out of compliance?What questi..
Silence about mental illness is costly and many who need help often suffer in silence. How do you as a leader, become comfortable with having a mental health conversation in a non-judgmental and supportive way and be more aware of the symptoms, frequency, and treatment options that may be available?One in five will experience a mental illness at some point in their lives. That means that every person is lik..
Unconscious bias in the workplace is a fact of life. Biases occur when individuals make spontaneous judgments about people or situations based on past experiences, culture, background, or exposure to media. These hidden preferences or prejudices can affect nearly every decision an organization makes. Biases can stymie diversity, recruiting and retention efforts and can unknowingly shape an organization’s cu..
This webinar will begin by discussing and emphasizing the importance of truthfulness to the process – truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, and finally in the context of this webinar, truthfulness when interacting with FDA inspectors. A key component of this webinar is the discussion of the..
Notified bodies and the FDA cannot require your suppliers to meet the quality system regulations, so they must make sure you are exercising sufficient control over those suppliers. You must make sure your supplier management and the system meet all required regulations, especially for critical suppliers.This webinar will review the QSR and ISO requirements for supplier evaluation, including defin..
The American Rescue Plan Act (ARPA) of 2021! New Guidelines by OSHA to Ensure Employers Have a Safety Process for COVID-19!
On March 12, 2021, the Occupational Safety and Health Administration (OSHA) launched a National Emphasis Program (NEP) that signaled a new enforcement agenda, targeting establishments in industries that have an increased potential for employee exposure to the Coronavirus 2019 (COVID-19) disease, including healthcare institutions. NEPs are temporary programs that focus OSHA’s resources on particular ha..
Every organization is set up to accomplish its primary business objective. Whether it is a “for-profit” organization or a “not-for-profit” organization, there is always a primary business objective. And whenever there is an objective, there is always the risk that the objective will not be achieved. Management has the responsibility to assess risks and establish controls to ensure that business o..
How well you communicate that information is critical to getting management’s acceptance of your findings and their agreement with your recommendations. A well-written audit report adds value to your clients by providing information that is:AccurateObjectiveClearConciseConstructiveCompleteTimelyIn addition to audit reports, these elements can apply to all kinds of writings including:Executive summariesFraud..