Compliance Training Webinars for Regulated Industries

The financial processes supporting a clinical research study is arguably the most important aspect of the study’s life cycle. Without an understanding of clinical research finance, organizations and individuals can unknowingly violate federal regulations and subject the organization participating in clinical research activities to fines, penalties and lost of reputation. This course will provide attendee with an overview of the federal regulations and guidelines governing the financial aspect of clinical research.

Attendees will learn the FDA expectations when investigating out-of-specification and out-of-trend laboratory results.

This IT Audit webinar facilitates an executive-level understanding of the ISACA IT Auditing Standards associated with performing IT assurance services and accepted areas of risk for most organizations through exposure to The Davis Adaptive IT Auditing System and Governance Tree frameworks. Webinar presents guidance following the general structure of planning, studying, testing, reporting, and follow-up. This structure can be applied broadly, or narrowly, defined IT audits.

In this webinar, you will learn how to properly complete I9s, conduct internal audits of their I9s, the proper procedures for correcting errors & omissions, retention rules, and how to prepare should they be audited by ICE. It is a violation of Federal immigration law for any employer to knowingly hire employees who are not authorized to work in the United States. The Federal Form I-9: Employment Eligibility Verification, is used by employers as a record of their basis for determining the eligibility of an employee to work in the U.S.

Money laundering continues to be a national concern. High levels of drug-related activity and violence have drawn additional attention. Terrorist activities need to be considered as well. Perpetrators have adapted to banks’ efforts so banks cannot combat the money laundering with yesterday’s methods. Software is widely installed to identify specific patterns and “unusual” transactions. But the launderers know this and are constantly striving to create new patterns where their transactions are designed not to be flagged. Like in a game of chess, the advantage goes to the side that thinks the most moves ahead. The AML Act of 2020 lays out some new directions for Federal actions but it will impact Banks due to changes in Customer Due Diligence and whistleblower rewards.

Corporations are facing more risks in the expanded environment of business. This webinar will provide auditors and audit management with advanced approaches to risk management and internal risk assessment at a corporate level.

Based on lean manufacturing and documentation concepts, this webinar deconstructs the supplier quality remediation process.

Penalties for late filing or filing incorrect W-2 Forms are on the rise. In addition, penalties for incorrect information on Form 941 can also be costly. This webinar will discuss methods for avoiding or correcting errors on Forms 941 and W-2 with a focus on how to make corrections where required so that penalties are eliminated or minimized. The webinar will discuss the preparation of Forms 941-X and W-2c correctly and highlight how and when to file the corrections. Correcting or amending returns for the 2020 and 2021 COVID-19 tax credits and tax deferrals will be covered

Dietary Supplement companies must ensure that any product claims they make are “truthful and not misleading” under FDA and FTC regulations. To meet these standards, the FTC has stated that claims must be substantiated by “competent and reliable scientific evidence.” This course provides strategies to: 1) identify claims; 2) characterize/rank claims; and 3) determine the level of scientific evidence needed to substantiate different types of claims.

This course will look at the new FDA direction and other programs aimed at transforming food safety in 2022 and beyond, including how to manage #483 violations for non-compliances.

The single most critical document in an FDA inspection is the master manufacturing record and associated batch production record. While the 21 CFR Part 111 regulations have a checklist of elements the documents must contain, it can be difficult to translate that into a working document. This training will review the basic principles of what an MMR & BPR must contain and give you tools to create an “FDA Acceptable” document.

Attend this course to gain practical approaches for supervision on the floor, strategies to get your group in sync and approach issues in GMP related environments by using a specific methodology to correct, prevent and avoid re-occurrence of these issues.

Attendees of this webinar will learn specific concepts and formulas commonly used to measure the ability of a process to produce output within customers’ specification limits. The focus of this webinar is on providing the information needed for attendees to know the appropriate measures and formulas to use for the various types of process data (attribute or variable).

In this webinar, we will discuss the definition, purpose, importance of GDP, General rules of GDP, GDP as it applies to laboratory notebook documentation, US Pharmacopeia General Chapter <1029>, and introduction “Good Documentation Guidelines”. We will also briefly introduce you to the European Union (EU) GDP, and its enforcement along with some observation samples from FDA.

In this pharmaceutical water system webinar attendees will learn how to design, validate and maintain the new and existing water systems used in drug product manufacturing process. Different types of routine tests, testing frequencies, actions in each tests and sampling procedures associated with pharmaceutical water systems will be discussed to avoid any water systems failures.

Clinical research revenue cycle (CRRC) is an integral part of a clinical research portfolio. It is a complex environment that bridges a health systems revenue cycle with clinical research activities. Health systems involved in clinical research activities struggle with effectively incorporating these two environments. In this course, attendees will learn framework for an effective and compliant CRRC program.

This webinar will explain what money laundering is, various types of money laundering including structuring, micro-structuring and cuckoo smurfing. Attendees will learn how to identify the red flags of money laundering in an account within your institution.

Are you ready for the FDA to knock on your door? Although an effective Quality System should always be inspection-ready, many medical device companies make basic mistakes during inspections leading to 483s and even warning letters. This webinar can help you manage inspections efficiently and effectively. A professional, polished, responsive approach sets a good tone for an inspection. You will learn how to present information about your quality system in the most competent and professional manner.

In this webinar attendees will learn current law and regulations regarding the preparation of Forms W-4 and the filing of Forms W-2 and will provide practical guidance in these areas that have become the subject of increasing IRS scrutiny. It will cover topics related to how to report cost of employer sponsored health coverage, How to handle expense reimbursements made to employees, process to efficiently execute an electronic W-4 program, requirements of Electronic filing with the SSA using Business Services Online (BSO).

This training covers DEA record-keeping and security topics that a DEA registrant must comply with when handling controlled substances. The focus is elements of what occurs during that unannounced inspection and the auditing methods.