
Medical Device Registration and Regulatory Submissions Know How for RA Professionals - Training Bundle
Daniel O Leary,Mercedes Massana,Cheryl Wagoner
11 Hrs
Product Id: 706835

Project Management for Medical Device Regulatory Affairs - Training Bundle
John E Lincoln,Edwin L Bills,David Dills
6 Hrs
Product Id: 706834

Lead Auditor EN ISO 13485:2016 and EU MDR 2017/745 - Regulation
Frank Stein
90 Min
Product Id: 706165
Attend this webinar to understand, what are the changes to the previous medical device regulation and how to implement the changes in your current quality management system in a simple and quick way. This need smart ideas to reach the right level to pass the quality management audit by your certification company or notified body.

Incoterms® 2020 Rules
Jan Seal
90 Min
Product Id: 706265
Attend this webinar to learn how to make correct use of Incoterms® to prevent delays and save additional costs. Learn how certain rules determine who is responsible for transportation, insurance, reporting the transaction to customs and much more.

Conducting Your 2022 Annual ACH Rules Compliance Audit - a Step-by-Step Guide
Donna K Olheiser
90 Min
Product Id: 705082
This session will cover “step-by-step” the audit process and requirements for each participant conducting an annual ACH audit, to help ensure their compliance with the Nacha Operating Rules.

EPCRA TRI Form "R" Reporting
Joe Keenan
90 Min
Product Id: 705126
This training program will help attendees understand the Emergency Planning and Community Right-to-Know Act (EPCRA) Toxic Release Inventory (TRI) Form R reporting requirements. It will also elucidate what the EPCRA TRI Form R is, when they are required to be filled out, and how to properly fill them out. Further, attendees will also learn how to calculate chemical mixtures as it applies to the TRI Form R reports.

How FDA trains its investigators to review CAPA and what should you do to prepare
Jeff Kasoff
60 Min
Product Id: 700851
This CAPA investigation training will discuss techniques used by the FDA to review your CAPA system. You will learn what the FDA tells their inspectors to focus in the QSIT document and how your company can use the same QSIT document to prepare for inspection.

Form 941 Essentials: Keys to Payroll Tax Compliance
Patrick A Haggerty
90 Min
Product Id: 706793
During the COVID-19 pandemic, Congress provided new employment tax credits and other tax relief, and Form 941 and related employment tax returns went through several major revisions to accommodate the changes. Going into the first quarter of 2022, the forms used by employers to report employment taxes continue to evolve to reflect the changes in the reporting requirements.

Navigating the Interplay of the Family and Medical Leave Act, the California Family Rights Act and the Pregnancy Discrimination Leave Act
Greg Chartier
75 Min
Product Id: 706823
This webinar will help to clarify the legal obligations under the different laws but, more importantly, help to explain how they interact with each other, or in some cases, don’t interact at all.

Applied Time Series Analysis in Healthcare
Elaine Eisenbeisz
3 Hrs
Product Id: 706758
This 3-hour seminar will provide attendees with the theory and application of time series analysis. The main focus will be on autoregressive integrated moving average (ARIMA) techniques. Variations of the ARIMA and other models which operate under non-linear data, non-stationary data, seasonality, and trends will also be examined.

Performing Effective Management Review of the Quality System
David L Chesney
90 Min
Product Id: 704933
This webinar will teach you how to conduct an effective management review of the quality system which helps you understand how to plan and focus on right metrics and governed by an efficient process. Participants will also understand FDA policy regarding disclosure of management review information during inspections.

Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance
Carolyn Troiano
90 Min
Product Id: 706348
FDA’s recent focus on data integrity during computer system validation inspections and audits has brought this issue to the forefront of importance for compliance of systems used in regulated industries. These include all systems that “touch” product, meaning they are used to create, collect, analyze, manage, transfer and report data regulated by FDA. All structured data, including databases, and unstructured data, including documents, spreadsheets, presentations, images, audio and video files, amongst others, must be managed and maintained with integrity throughout their entire life cycle. It is a risk-based approach that leads to the best results and compliance with FDA’s expectations.

Best Practices in Utilization Management including a Review of the Conditions of Participation
Toni Cesta
60 Min
Product Id: 706359
Attend this webinar to learn how to stream-line your utilization management process and understand the Conditions of Participation for Utilization Review and how they impact on your work as a case manager.

The FDA Inspection Process: From SOP to 483
Jeff Kasoff
60 Min
Product Id: 700269
This is a detailed course designed to provide 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.

Bank Best Practices to Prevent Fraud
Jim George
60 Min
Product Id: 706805
Continued massive data exposures have put the spotlight on fraud risks to banks, merchants, and personal banking customers. Fraudsters are always looking for new opportunities and new weaknesses. The availability of customer data on the black-market gives them new power tools to use to enrich themselves. A bank has responsibilities to its shareholders and customers to protect them from these ever-changing threats.

FFIEC BSA/AML Examination Manual: What Compliance Officers Really Need to Know?
Doug Keipper
60 Min
Product Id: 703792
This webinar will go through every section of the revised FFIEC Bank Secrecy Act/Anti-Money Laundering Examination Manual to highlight changes and areas where banks should review their internal policies, processes and procedures for compliance. Understanding these changes will keep you prepared and updated for your next BSA/AML examination.

Introduction to Sales and Use Tax Compliance
Miles Hutchinson
120 Min
Product Id: 706802
Sales tax? Use tax? What’s the difference? Must I charge tax on my internet sales? Will I owe taxes in more than one state for the same sale? Why is my drop shipper charging me tax? Why did I receive a NEXUS Questionnaire and what if I don’t respond to it? I just received a notice that I have to conduct a self-audit and report my findings to the state – is this for real? I need help!

Fraud Incident Response Planning Essentials
Richard Cascarino
60 Min
Product Id: 706796
In today’s world, fraud investigations have become an everyday part of corporate life and the auditor must gain expertise in this area. The webinar covers such issues as the tasks of the fraud auditor, Forensic techniques and tools and the abilities required of the fraud auditor, the type and nature of common frauds, investigating fraud, computer fraud and control, white collar crime, the auditor in court.

ANDA Submission and GDUFA Guidance
Charles H Paul
60 Min
Product Id: 706791
An ANDA is an Abbreviated New Drug Application. This application is submitted to the FDA to seek approval to produce a U.S. generic drug from an existing patented approved drug. The ANDA is submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs. After approval, the applicant is able to produce and market the generic drug product.

21 CFR Part 111 - Specification Requirements
Andy Swenson
60 Min
Product Id: 706794
The 21 CFR Part 111 dietary supplement regulations require six categories of specifications before established before manufacturing product or releasing a batch into distribution. This course will review the six categories and their regulatory requirements while translating those requirements into a workable document.