Compliance Training Webinars for Regulated Industries

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.

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.

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.

This training program will detail how to create a bullet-proof AP operation that is setup to detect and proactively prevent fraud from occurring. During this session, the webinar presenter will discuss real cases of AP fraud and the controls that organizations later realized needed to be added to their AP operation, unfortunately too late to prevent these costly incidents. In addition to discussing good controls, he will also discuss common controls that are ineffective, provide no value, or even leave AP departments with a false sense of security while they are in reality still very much exposed.

This webinar will explain the Civil Monetary Penalties Law (CMP) and its mandatory and permissive exclusions and penalties. It will also cover obligations under EMTALA, violations of the Anti-Kickback Statute and Stark including amendments under the PPACA.

In today’s world, every organization no matter how large or small needs an Incident Response Plan in place to quickly manage and address the consequences of a breach. The volatility of today’s threat landscape makes an incident response (IR) more challenging than ever. This webinar is designed to give information security professionals an overview of the various considerations and aides in IR planning.

Did you know that every employer, regardless of industry, has the potential of an employee working alone? Regardless if the employee is working alone for an entire shift, partial or a very small percentage, providing safety for that employee is essential for meeting regulatory compliance.

This webinar provides the logic and processes for determining samples sizes for common tests used in verification or validation of processes. The focus of this webinar is on providing the information needed for attendees to know the appropriate measures and formulas to use for the determining sample size and providing justification for the planned sample sizes.

This webinar will teach how to calculate the Z-score and “correctly” interpret it based on a straight-forward scale. Five-step “key ratio analysis ” plan (liquidity, activity, leverage, operating performance, and cash flow analysis) will be displayed and tied into the comprehensive calculation of the Z-score. The session will conclude with a review of using sophisticated software such as Moody’s Lending Cloud to calculate both the Z-score and key ratios.

In this webinar, you will get an overview of FDA’s medical device Quality System Regulation, 21 CFR Part 820.

This 60-minute session on master verification and validation planning will discuss the major cGMP deficiencies and "must have" elements from the U.S. FDA cGMP, ICH Q9 and ISO 14971 for hazard analysis and product risk management, and show how you can integrate these into a company's quality management system.

This training program will discuss designing an effective cleanroom facility validation protocol and report, when and how to transition into the routine environmental monitoring processes, how to maintain a state of control within the cleanroom, and the routine environmental monitoring and excursion investigation processes.

In this program we will start by reviewing the current rules for discharge planning. Are you compliant with these rules? The newly enacted rules that are now required under the Medicare program’s conditions of participation will be reviewed as they may have a profound effect on how case management departments organize their work. Family caregivers and physicians are expected to be much more involved than they have in the past. This program will review the current rules and regulations from the Conditions of Participation (CoP) for Discharge Planning.

Be sure you know the old rules and the new rules so that your practice will be current and legal! We will review strategies for integrating these requirements into your daily practice.

This Change Control training program will discuss regulatory expectations from the FDA, EU and ICH perspective, review all the required components of a thorough change control program; as well as, discuss the elements regarding successful management an effective Change Control system.

There are several steps that must be taken to determine if an incident is a breach, and whether or not that breach is reportable. Determining whether to report or not is not necessarily straightforward, but there are guidelines to follow to help at every step of the way. If the evaluation of necessity to report is not done correctly, you may not make the right decisions about reporting and be subject to penalties for non-compliance upon an investigation of a breach by HHS. Penalties for non-compliance can up to millions of dollars in cases of willful negligence, so it is essential to evaluate incidents to see if they are reportable breaches, and act properly on the evaluation.

Pivot Tables are one of the most powerful tools in Excel’s arsenal of data analytics. With just a few clicks, and no complicated formulas or macros, you can quickly and easily build incredibly informative reports, charts and dashboards. In this webinar, you’ll learn Pivot Table techniques that will instantly filter, summarize and analyze huge amounts of raw data. You will learn to use advanced Pivot Table techniques to rapidly produce critical information that will highlight the algorithms and trends buried in reams of data.

In this webinar, you will learn why the FDA requires several validation participants from each “distinct user population”. Learn why the FDA requires many validation participants from each "different user demographic" in this webinar. We'll go over how to determine which tests to run and which studies to finish before the actual validation test.

In this training program, attendees will discover how to create a record of disruptive behavior and the efforts taken by the organization to combat the problem. The webinar will also illustrate why such disruptive behavior can be a continuing problem; and therefore, why appropriate documentation is imperative.