
NEW Nacha Rule – Third-Party Sender (TPS) Roles and Responsibilities
Donna K Olheiser
90 Min
Product Id: 706803
This session will help the attendee to identify a Third-Party Sender (TPS) and a “nested” TPS. In addition, we will cover the details needed in the agreements between all parties and what parties based on their role. Discussion on the registration requirement for both the TPS and the nested TPS and what that means to the ODFI.

US FDA Labeling Requirements for Medical Devices
John E Lincoln
90 Min
Product Id: 706873
The definition of labels is well defined and ususally well known; "labeling" not so well. Differing requirements for different applications can be confusing and are the subject of this webinar.

Pharmaceutical Data Integrity
Mark Powell
60 Min
Product Id: 706101
Data Integrity has been the subject of increasing scrutiny during pharmaceutical regulatory inspections in recent years. Chromatographic data systems have received particular attention because of the potential for data manipulation to produce fraudulent data or uncontrolled changes in processing parameters that compromise the comparability of results between runs. This webinar explains the intention behind data integrity regulations, sets out current expectations and suggests an approach to compliance based on sound science.

Medical Device Change(s) and the 510(k)
John E Lincoln
90 Min
Product Id: 701742
This 90-minute webinar will provide valuable assistance to all regulated companies performing and documenting meaningful, results driven 510(k) / change analysis activities, based on the FDA's new Draft Guidance, "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device", dated October 25, 2017.

Credit Risk Management: Principles and Practices, Tools and Techniques
Dev Strischek
120 Min
Product Id: 706863
This course provides guidance in how to implement and maintain the desired level of credit risk management with practical tools and techniques. Both the market and the regulatory agencies expect credit risk management to reflect the bank’s credit culture, so the class also offers direction on how to identify the organization’s credit culture and to reposition it to support the desired credit risk culture and management.

W-2 and W-4 Update and Best Practices
Miles Hutchinson
90 Min
Product Id: 704333
This webinar will prepare your staff for this filing year, improve your employee reporting set-up and maintenance practices, and reduce your risk of complaints from the IRS. Learn the latest updates on Form W-4 and Form W-2 wage and withholding reporting.

FDA Modernization and Restructuring of the SDLC for Computer System Validation (CSV) and Compliance
Carolyn Troiano
90 Min
Product Id: 706561
As a “GxP” system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements. If electronic records and/or electronic signatures (ER/ES) are incorporated into the system, FDA’s CFR Part 11 guidance on ER/ES must be followed to assure data integrity is maintained. This webinar will focus on the efforts by FDA to modernize their own technology infrastructure, and what this means to industry. We will cover the Technology Modernization Action Plan (TMAP) that has been launched by FDA for this purpose and discuss specific actions that are planned and in progress.

Supervising a Human Error Free Environment: You can do a Lot More than you Think
Ginette M Collazo
90 Min
Product Id: 706861
This training would provide tools that can be implemented and used after this event. This includes practical tools. We will discuss why supervision is so important in reducing and preventing human error. Supervision approaches near root causes and root causes for supervision related errors and will address the main five elements to assure an error-free environment.

Good Laboratory Practices by Using The Quality Management System (QMS)
John Fetzer
4 Hrs
Product Id: 706858
This GLP quality system webinar provides a general overview of the Proposed Rule, a GLP QMS and its implementation, GAP analysis, Plan-Do-Check-Act cycle, process control and optimization theory and quality audits are utilized for the analysis of an existing QMS and the potential benefits, barriers steps to implementing an optimized GLP QMS.

Transfer of Analytical Methods according to USP <1224>
Mark Powell
60 Min
Product Id: 706036
In this analytical method transfer webinar attendees will learn the options available for the transfer of validated, non-compendial methods to a different site. In addition to current regulatory guidance, the different options for method transfer will be discussed. The webinar will set out an efficient, risk-based approach that reduces effort whilst meeting the requirements of regulators.

Risk Compliance Matrix for Internal Audit and SOX Operations - Active and Engaged Risk Management Activities
Marna Steuart
75 Min
Product Id: 704809
21st century business organizations require active and engaged risk management activities. Today's risk and compliance process is rather complex and dynamic, therefore it requires governance, risk and compliance professionals to possess certain skills in order to effectively complete their duties and responsibilities. The days of using staid audit programs are over. This training program will engage participants in evaluating each business process using a risk-based approach and in preparing risk and compliance documentation for each engagement.

TIN Matching to Reduce Your B-Notices and Eliminate Proposed Penalties
Miles Hutchinson
90 Min
Product Id: 703028
Learn the best practices for eliminating 1099 error notices from the IRS. Discover the power of the TIN Matching system. Discover the smoothest way to register to use the two step verification process introduced 12/10/17. Learn how to handle the CP-2100 notices from Uncle Sam and avoid the fines & penalties for failure to timely comply with the B-Notice requirements. Understand the difference between and 1st and 2nd B-Notice and the related differences in required vendor responses. Be sure you institute and stop Backup Withholding when required. Join us for a content-rich 2-hours and you will gain the tools to make you the most effective information return manager your company has ever seen.

Validation Sampling Plans
Alan M Golden
60 Min
Product Id: 706332
This webinar will discuss setting up statistically justified sampling plans for process validation. Discussion will also involve using the sampling plan to set acceptance criteria for process validation. Setting acceptance criteria for test method validation will also be presented.

Nacha New Rule on Meaningful Modernization – All the Details
Donna K Olheiser
90 Min
Product Id: 706779
Recent updates to the Nacha Operating Rules were developed to enhance the ACH “user” experience with improvements and simplification by adopting new technologies and channels for the authorization and initiation of ACH payments. Included in the change was a reduction to the barriers when using the ACH Network by providing clarity and increasing consistency pertaining to certain ACH authorization processes and by reducing some of the administrative burdens related to ACH authorizations. What does all this mean will be covered in this 90-minute webinar, explaining how this new Rule applies (and it is optional for Originator/ODFI).

Compliance with the American with Disabilities Act (ADA): What Employers Need to Know in 2022
Diane L Dee
90 Min
Product Id: 705608
This webinar will provide participants with a comprehensive understanding of the Americans with Disabilities Act and will explain the importance of compliance and the consequences of non-compliance. Participants will gain a solid understanding of the ADA’s disability accommodation process and the interactions between Federal and State laws.

Powerful Closed-loop CAPA - Meeting FDA Expectations
John E Lincoln
90 Min
Product Id: 702012
This 90-minute webinar will show how you can implement a closed-loop CAPA system that meets CGMP requirements and U.S. FDA expectations. You will learn simple, but powerful, tools and methods that you can use regularly and systematically to define and resolve root causes, not just symptoms.

Non-Resident Importer in Canada: Responsibilities, Rights, Benefits and More
Fabiola Ferrusquia
60 Min
Product Id: 705463
This webinar will discuss the process of becoming a Canadian Non Resident Importer. Attendees will learn how to attain business registration number, HS tariff classification and tariff treatment, process of claiming GST on imported goods, ways to complete the Canada customs invoice and more.

Being Prepared for an Active Shooter Incident at Workplace
Michael Aust
60 Min
Product Id: 704652
This training program will take attendees through the actions to take when confronted with an active shooter and in assisting responding law enforcement officials. It will help recognize potential workplace violence indicators and describe actions to take to prevent and explore the General Duty Clause of the OSH Act.

Project Management for FDA-Regulated Companies
John E Lincoln
90 Min
Product Id: 701758
This project management training for FDA regulated companies will show how you can meet key FDA and EU MDD regulatory requirements for the project you manage. It will focus on proven tools and techniques for successful development and implementation of project management planning.

How to Prepare for and Conduct a Regulatory Audit
Alan M Golden
60 Min
Product Id: 706849
In this Regulatory Audit training participants will gain an understanding of how to prepare for and audit, strategies to conduct and support a successful audit, and ways to respond to audit observations. Special consideration will be given to virtual audits as a result of the Covid-19 Pandemic.