Live Webinar: The Complexity and Interplay Among ADAAA, FMLA, and Worker's Comp (WC) - How Do They Work Together, or Not ? When: Wednesday August 25, 2021 - 01:00 PM Duration: 90 Minutes. Register Now Ensuring compliance with FMLA can be frustrating for many HR professionals who are uncomfortable with the Act. This leads to litigation. Then, to add the ADAAA legal requirements adds to the confusion which can also lead to discrimination under civil rights law. Sometimes sprinkled in with FMLA and the ADAAA is WC – the nexus among the three legal requirements, especially as it relates to leave, medical certification, and getting the employee back to work as quickly as possible, can be daunting. This webinar will separate the three laws and examine how each law applies to work situations. Why one should attend the training: To review the intricacies of how WC, ADAAA, and WC intersect to provide employees’ coverage under these acts To discuss the challenges in terminating an employee after they have expended their FMLA benefits without ignoring their rights through the ADAAA or state laws To identify steps to follow when an employee fails to provide the requested and required medical certification To explain the process in responding to an intermittent leave request that may include a potential ADAAA accommodat To clarify a physical or mental impairment that substantially limits one or more major life activities based on the ADAAA

Live Webinar: HR Compliance 101 - For New HR/Non - HR Managers, Including COVID-19 When: Tuesday August 31, 2021 - 01:00 PM Duration: 90 Minutes. Click here to Register Webinar In an increasingly complicated world of employee compliance in which HR struggles just to keep abreast of new developments, not teaching managers the basics can be costly. After all, it's the managers who interact with employees on a day-to-day basis and every day is an opportunity for problems to arise that a manager was never trained in how to address. Why should you attend? By the time an employee problem reaches HR, a level of liability has often been created. How an employer handles such problems, can either limit or increase liability. Further exacerbating the problem is that managers often inherit a dysfunctional department and/or are promoted to supervise those with whom they once were co-workers. Areas Covered in the Session: Basics of the Big Four of employment compliance- Title VII, FLSA, FMLA, ADA Employee Relations Safety Management Register soon because space is limited. We hope you’re able to join us!

Live Webinar: Identifying and Proper Management of High-Risk Transactions and Customers When: Friday September 10, 2021 - 03:00 PM Duration: 60 Minutes. Register Now This BSA/AML webinar is intended to assist attendees understand, identify, and mitigate the risks associated with high risk transactions, and to properly manage them. Reasons to Attend: An effective BSA/AML compliance program controls risks associated with the institution’s products, services, customers, entities, and geographic locations. Risk assessments are a critical component and play a key role in ensuring your high-risk transactions are properly monitored. BSA/AML risk assessments require you to identify the specific risk categories (i.e., products, services, customers, entities, transactions, and geographic locations), understand its characteristics, and establish internal controls to assist in risk mitigation. Areas Covered: Identifying high risk transactions Identifying high risk customers Understanding high risk activity Risk assessment for products and services. Systems of internal controls. Managing high risk transactions and customers. Monitoring for suspicious activity and ensuring your institution is vigilant

Live Virtual Webinar: Risk Management of Source Water used in the Food Industry When: Thursday September 9, 2021 - 01:00 PM Duration: 60 Minutes. Register Now We tend to take the safety of our drinking sources for granted, but our assessment of potability is suspect. Learn what can be done to address the issue of source water protection and the potential impact on the food industry. We are dependent on water to sustain life, but groundwater sources of our potable supplies are under pressure by the demand for water in the food industry. The focus of this webinar will be to address the limitations of how potability is currently defined and examine options for mitigating the risks of waterborne/foodborne illness through the protection of source water using a multi-barrier approach. Areas Covered in the Webinar: Current criteria for determining water potability Alternative approaches to risk management of water used in food processing Principles and recommendations for source water protection from a food processing perspective Learning Objectives: Understand the basis for current microbiological indicators for assessing water potability Be aware of some principles and recommendations for source water protection from a microbiological perspective Register soon because space is limited. We hope you’re able to join us!

Live Webinar: Cross Contamination Flow through the Food Supply Chain When: Tuesday Jul 27, 2021 - 01:00 PM EST Duration: 60 Minutes. Click here to Register Webinar Most information and training surrounding food cross contamination is focused primarily on bacteria in the kitchen and the need to separate utensils and work area of one type of food from another. Why you should Attend: The food industry is in dire need of expanding proven cross contamination thinking and practices to a more comprehensive and preventive level. This 1 hour session focuses on potential cross contamination points from farm harvest bins, onto pallets and through load and unload operations and into truck trailers and shipping containers. A comprehensive, risk reducing preventive approach is presented along with a basic set of low cost tools covering temperature monitoring, sanitation, environmental protection, traceability, sampling and test, training, documentation and transporter certification and insurance coverage. Areas Covered in the Session: Practices for preventing cross contamination in food distribution channels Product and services designed to establish a preventive program How to upgrade your sanitation, testing, temperature monitoring and record keeping procedures Points of potential cross contamination in distribution centers, pick and place operations, packing houses, trucks, pallets, bins, trays, and other food carrying containers FDA FSMA proposed rules on the sanitary transportation of human and animal foods Sanitation and temperature controls Traceability through logistics processes Proposed procedures for company use Contact Person: SAM +1 3156320735

The Susceptible, Infected, and Recovered (SIR) Model for Covid-19 When: Tuesday Jul 27, 2021 - 01:00 PM EST Duration: 60 Minutes. Click here to Register Webinar While the NPIs have obviously failed to contain Covid-19 due primarily to noncompliance among the general public (which is linked in turn to general lack of understanding of the underlying science), they did end the 2019-2020 flu season about a month early and will probably result in no substantial 2020-2021 flu season whatsoever. This is because there is a vaccine for seasonal flu, many if not most people avail themselves of its protection every year, and the 2019-2020 seasonal flu could not survive the combined effects of the NPIs and the vaccine. The NPIs were however unable to end Covid-19, for which there is no vaccine, by themselves. Areas Covered in the Session: The physical and economic dangers associated with Covid-19 are obvious. The disease has a relatively high (on the order of 2%, lower for younger people and higher for older ones) lethality, is extremely contagious, and is often asymptomatic. People who have it might not know they can give it to others, and even survivors can suffer lifelong damage. The good news is however that non-pharmaceutical interventions (NPIs) can reduce the disease's menace to allow businesses to reopen safely. They also work against seasonal flu and have already, in combination with the annual vaccine for that disease, ended the 2019-2020 flu season about a month early. We can predict reasonably that there will be no 2020-2021 flu season for the same reason, and the takeaway is that the NPIs are effective. NPIs impede both Covid-19 and seasonal flu by suppressing their basic reproduction numbers (NPIs) Vaccination (like herd immunity) puts a substantial fraction of the population into the Recovered (and immune) category, but without the risks associated with getting the disease itself. If a portion of the population is vaccinated against seasonal flu, R0 does not need to be reduced to less than 1 to have the same effect. There is not yet a vaccine against Covid-19 so NPIs are currently our only way to suppress it. These include, in descending order of preference,

Live Webinar: Establishing BSA Customer Risk Ratings and CDD Guidance: Best Business Practices for 2020 When: Wednesday Jul 28, 2021 - 01:00 PM EST Duration: 60 Minutes. Click here to Register Webinar The new CDD Chapter of FFIEC outlines the expectation to risk rate customers. “The bank should have an understanding of the money laundering and terrorist financing risk of its customers, referred to in the rule as the customer risk profile”. This concept is referred to as customer risk rating. How do financial institutions effectively risk rate their customers at account opening and throughout the duration of the relationship? What risk rating criteria should be used and what is the best method for performing ongoing due diligence based on this risk rating. Financial institutions will learn how to risk rate high risk customers, what the expectations are for moderate and low risk customers and how to effectively perform ongoing risk reviews. Topics include: Overview of High-Risk Customers FFIEC Guidance on Risk Rating Most recent changes to guidance on CDD and performing ongoing EDD Best business practices for risk rating at account opening and throughout duration of relationship Documentation requirements

Live Webinar: USP <71> Sterility Tests; Method, Limitations, Sampling Quantities and Volumes to Conform with United States Pharmacopeia When: Wednesday Jul 28, 2021 - 01:00 PM Duration: 90 Minutes. Click here to Register Webinar USP<71> Sterility Tests represents the "Gold Standard" for sterility testing. Together with both the European Pharmacopeia (EP 2.6.1 Sterility) and the Japanese Pharmacopeia (JP 4.06 Sterility Test), they represent a 90+% harmonised test method that is utilised to determine the sterility of a product. The objective of this webinar is to obtain an enhanced understanding of USP <71> Sterility Tests, its inherent method, limitations, sampling quantities and volumes to assure that the test is being applied as appropriate per United States Pharmacopeia and how to interpret the final result, regardless of whether it represents a pass or a failure. Review of Case Studies/Warning Letters will also be reviewed to further explain this document. Learning Benefits: Methods of sterility testing. Review of the appropriate media to use for sterility testing. Determination of the quantity of each article for testing and why. Review of number of items for each medium and why. How to select the appropriate technique for testing. Use of diluents with sterility testing. Interpretation of the results – regardless of a pass or failure. Review of pertinent Warning Letters.

Live Seminar: 2-Day Virtual Seminar Method Development and Validation for Assays Supporting Testing of Biologics When: Thursday & Friday Jun 24 - Jun 25 ,2021 DAY 01 & Day 02 (9:00 AM TO 5:00 PM EDT). Click here to Register Seminar Biologics continue to be a steadily growing component of the pharmaceutical industry. The advent of large molecule therapeutics requires a different perspective on the assays needed to support development through preclinical and clinical testing. This 2-day seminar is designed to offer a broad overview of developing and validating a range of assay methodologies for biologics with specific key analysis of cell culture, assay variability, and DOE. Specifically, this seminar covers essential concepts related to cell-based potency methods, ELISA, and other methods supporting biologics. Learning Objectives: Understanding the different requirements for small versus large molecules Mapping appropriate timelines with decision points Designing, developing, optimizing, and validating key methods Potency methods, other release and stability methods Preclinical and clinical methods Use of DOE and statistical analysis Handling of critical materials Process monitoring concepts Assessment of orthogonal methods Assessing readiness for validation Defining the validation protocol with real-time capture of data analysis Maintaining quality through documentation

Seminar:2-Day Virtual Seminar Quality and GMP Compliance for Virtual Companies(Pharmaceutical and Biologics Industries) When:Thursday & Friday July 15-July 16,2021 DAY 01 & 02 (11:00 AM - 3:00 PM EST). Click here to Register Seminar Today, many companies operate on an outsourcing model. This is very common for companies who are evolving from being mainly development-focused to a point where they are entering later stages of Phase 2 or Phase 3 clinical trials and plan to have a product ready for market approval in the coming months. Most such companies are small, and may not have deep expertise in QA and GMP compliance, relying on their partners to cover those areas. Companies that outsource the majority of operations through the use of Contract Manufacturing Organizations (CMOS), Contract Research Organizations (CROs), and Contract Laboratories, however, remain responsible for the quality and compliance status of the products they send to the clinic or to the marketplace. Learning Objectives: Participants in this seminar will: Understand the GMP and GCP requirements all virtual companies must meet regardless of the extent of their outsourcing operations Understand how to select, qualify and monitor CMOs, CROs, and Contract Laboratories Learn the elements to include in a quality agreement (also known as a technical agreement) Learn how to determine which GMP or GCP requirements apply to you, depending on the things you do internally and those you outsource Understand your obligations under the law for products you release to the clinic or the marketplace Appreciate the importance of maintaining data integrity Learn how to effectively manage a health regulatory inspection: Inspection logistics Responding effectively to document requests and questions from inspectors Managing the inspection exit discussion How to write an effective response to inspection observations

Live Webinar: The FDA Inspection: Best Practices for Preparation, Management, and Follow-Up When: Friday Jun 18, 2021 - 11:00 AM EST Duration: 60 Minutes. Click here to Register Webinar This course provides medical device/pharmaceutical professionals with the information they need to prepare for and manage any type of FDA inspection. This course provides the rationale, strategies and flow on how to plan for an inspection, the inspection process and approach, and which company roles should be assigned for these types of inspections, among other related topics. Areas Covered in the seminar: Types of Inspections Preparation Dedicated personnel for inspection Facility resources to support the inspection Internal audits SOP for inspections Behavior during inspection: What to say and do, and what NOT to say and do Inspection process How and when to craft a written response

Live Webinar: Don't Let Finance Run the Factory When: Tuesday Jun 22, 2021 - 01:00 PM Duration: 60 Minutes. Click here to Register Webinar While generally accepted accounting procedures must be used to prepare financial statements and tax returns, traditional cost accounting is indeed totally unsuited to managerial decision making and can drive dysfunctional behavior such as generation of unsaleable inventory to "absorb overhead." Cost accounting treats inventory as an asset, which it might indeed be on paper, but it ties up money, increases cycle times, and gives quality problems a place to hide. This presentation will show how to use relevant metrics for effective decision processes. Areas Covered in the Session: Traditional cost accounting methods are mandatory for tax and financial reporting, but their application to managerial decision processes can make them more destructive to organizational performance than many forms of poor quality. When Cheap is Costly Inventory is Not an Asset (even if must be treated by one by the accounting system). It ties up capital, increases cycle time, and gives defects a place to hide. Variable costs often aren't. Labor is, unless overtime is being paid, a fixed cost regardless of what the cost accounting system calls it. Treatment of labor (and, even worse, overhead costs) as variable costs could easily result in the decision to turn down marginally profitable work—that is, the revenue from each item sold exceeds the cost of making it—because it would generate a loss on paper.