Compliance Training Webinars for Regulated Industries

FDA, in November 2016, issued a Guidance explaining and clarifying the existing MDR regulation. Many of the details of the MDR regulation were unclear and ambiguous and resulted in nonconformances. This new Guidance attempts to eliminate confusion.

Section 1557 of the Affordable Care Act (ACA) forbids discrimination based on sex, race, color, national origin, age and disability. It builds on longstanding and familiar federal civil rights laws but is the first law to prohibit discrimination on the basis of sex (which includes gender, gender identity and sex stereotyping) in covered health programs and activities. Sex discrimination also includes discriminatory treatment on the basis of pregnancy, false pregnancy, termination of pregnancy, recovering from pregnancy, childbirth and related medical conditions, sex stereotyping, and gender identity.

This 90-minute training program is designed for people tasked with performing external audits for their organizations. It is also for those tasked with developing, maintaining and/or improving programs for manufacturing facilities. This includes individuals that have quality management system responsibilities for making general improvements in their organization’s performance specifically related to equipment, processes and documentation.

This training program will illustrate five effective personal actions to enhance a safer workplace and describe the four different phases of the safety maturity curve. It will explain the four most common deflections of a safe workplace and how to minimize their impact.

This training program will discuss the history of US Customs, including the US Customs Modernization Act (Mod Act). It will also detail the roles and responsibilities of customs versus the importer.

This webinar will discuss 4 key payroll practices that will be crucial to the department in 2017. These practices will increase efficiency, cut costs, prevent fines and penalties for errors and help the department identify areas to focus on for improvement in 2017 and beyond. The training session will address other payroll essentials such as why it isn’t just Forms W-2 that are being scrutinized by the IRS - it is also fringe benefits and all tax practices.

This course will review the basic requirements of pet food nutritional labeling, including the eight required items all pet food labels must have and the agencies that define and enforce the rules. The course will also cover frequently asked questions within the industry including guaranteed analysis and calculating calorie content. For pet food manufacturers wishing to ensure compliance to the latest nutritional labeling standard, this course offers an overview of the necessary elements to ensure compliance.

In this training program, participants will learn how to compute the correct or target annual withholding to avoid underwithheld tax penalties, understand how to test employer designed withholding methods for compliance with IRS requirements, and learn to compute withholding using the four alternative methods provided by the IRS.

This training program will focus on NEPA (National Environmental Policy Act) national environmental policies and goals. It will also discuss provisions for governmental agencies to effect NEPA, establishing the QEC in the Executive Office of the President.

This training program will define and discuss mediation, arbitration and fact-finding. It will enumerate best practices to prepare for the process, checklist of areas to remember, key considerations such as evidence and witnesses, and essential questions to ask.

This OSHA training program will discuss current OSHA standards, directives, emphasis programs and interpretative letters that could be revised under the new Trump administration. It will discuss possible changes in OSHA’s regulatory agenda for 2017 and illustrate the three options a new administration has to rescind regulations from the former administration. The webinar instructor will also offer insight into whether OSHA’s budget will remain the same, decrease or increase under the new administration.

This training program will offer a complete set of best practices for preparing for an export control audit. The course will also discuss performing your own proactive review of policies, procedures, transactions, and record keeping and managing the audit process and keeping management informed.

This training program will address how the impact of multiple free trade agreements will have an effect on a merchant’s duty rates and resources allocation, production, and trade patterns. It will focus on the duty management roles when it relates to the importer in understanding how to reduce taxes and tariff costs in the geopolitical international trading environment.

This 90-minute webinar will cover general considerations for microbial control for non-sterile manufacturing areas, including attributes of an effective cleaning and disinfection program. Points to consider specifically aimed at oral solid dose (OSD) manufacturers will also be presented, including cleaning and disinfection of both product contact and non-product contact surfaces.

The webinar will address the various records required by government agencies in the commercial conversion and packaging of food production. This webinar is designed to allow field level management to competently represent the local process and records as they are intended to satisfy the regulation.

The third webinar in the series, this training program will provide an in depth overview of the new/updated concept of ISO 45001 and compare OHSAS 18001 to ISO 45001.

Any time a health care organization structures a contract involving physicians, it must be aware of the federal laws that are unique to the healthcare industry (e.g., the Stark Law, Anti-Kickback Statute, Civil Monetary Penalties Law, False Claims Act, etc.). These laws affect any contract with physicians who are in a position to refer, including employment or service contracts, group compensation structures, joint ventures, leases for space or equipment, free or discounted items or services and virtually any other exchange of remuneration.

In this webinar, participants will know what kind of information is required for an EEI(Electronic Export Information) filing and will be more conscious of the importance of EEI filing accuracy. The instructor will explain how to file his/her own EEI timely, the AESDirect EEI fields and how to run basic export reports in ACE.

Analyzing processes to understand their operation and implementing improvement is a necessary element in any quality system, but is especially important in medical devices. One of the more important tools is linear regression. Using Excel, you can get the information you need for process improvement.

The training program will discuss common elements of compliance program requirements across different legal areas. Using these guidelines, a company will be able to develop an operational program that will manage a company’s export decisions and export transactions in compliance with the Export Administration Regulations (EAR).