
Strategies for Substantiating Structure-Function Claims for Dietary Supplements in the United States
Travis Austin MacKay
60 Min
Product Id: 706585
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.

Human Error Reduction Techniques for Floor Supervisors
Ginette M Collazo
90 Min
Product Id: 706137
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.

Calculations for Process and Product Capability
Elaine Eisenbeisz
90 Min
Product Id: 706629
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).

Pharmaceutical Water System: Design, Testing and Data Management
Charity Ogunsanya
90 Min
Product Id: 705863
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.

Red Flags of Money Laundering
Doug Keipper
60 Min
Product Id: 703417
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.

Payroll Tax Update and Filing of W-2 and W-4 for 2020: Preparing for January 2021 Deadline
Miles Hutchinson
90 Min
Product Id: 705831
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).

How to Survive a DEA Inspection Series - For Manufacturers of Controlled Substances
Carlos M Aquino
90 Min
Product Id: 705164
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.

Process Validation Requirements & Compliance Strategies
Jose Mora
60 Min
Product Id: 700162
This Process Validation Requirements webinar will review process validation basics, with emphasis on looking beyond compliance towards achieving a robust process. Review of process validation basics, with emphasis on looking beyond compliance towards achieving a robust process.

Using Controls and Segregation of Duties to Build a Bullet Proof AP Operation
Brian G Rosenberg
60 Min
Product Id: 704051
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.

Healthcare Fraud Webinar - False Claims, Stark, Anti-Kickback Statute, and Civil Monetary Penalties Law
William Mack Copeland
60 Min
Product Id: 703413
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.

On the Alert: Crafting an Effective Incident Response Plan (IRP)
Robert Davis
60 Min
Product Id: 706693
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.

Lone Worker Safety Compliance
Michael Aust
120 Min
Product Id: 706399
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.

Calculating the Z-Score "Bankruptcy Predictor" Model
David L Osburn
90 Min
Product Id: 705795
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.

Introduction to Medical Device Quality System Regulations
Paul Larocque
90 Min
Product Id: 706648
In this webinar, you will get an overview of FDA’s medical device Quality System Regulation, 21 CFR Part 820.

How to Achieve a Compliant and Effective Cleanroom Design and Facility Validation
Charity Ogunsanya
90 Min
Product Id: 703875
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.

An Update on Discharge Planning Rules and Regulations for 2022
Toni Cesta
60 Min
Product Id: 705120
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.

Implementing a Robust and Compliant Change Control Program
Kelly Thomas
90 Min
Product Id: 705909
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.

HIPAA Breach Evaluation and Reporting - What Qualifies as a Reportable Breach and how to Report It
Jim Sheldon-Dean
90 Min
Product Id: 705214
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.

MS Excel: Advanced Pivot Tables for Superior Data Analytics
Joe Weil
90 Min
Product Id: 705379
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.

How to Conduct a Human Factors / Usability Validation
Jose Mora
60 Min
Product Id: 706764
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.