
Monitoring High Risk Transactions
Doug Keipper
60 Min
Product Id: 703001
This BSA/AML (Bank Secrecy Act/ Anti Money Laundering) compliance training will help attendees understand, identify and mitigate the risks associated with high risk transactions.

Writing High-Impact Executive Summaries
Phil Vassallo
90 Min
Product Id: 704127
This training program will help attendees approach the writing situation with a clear and useful strategy. It will include strategies to fuse the purpose of the summary with the issues that matter to your audience. Attendees will also learn to sort ideas to clarify key points and craft paragraphs that reinforce the intent of the executive summary.

Mentorships: A "Must-Have" for Recruiting and Retaining Employees in the New Remote and Hybrid Workplace
Maure Ann Metzger
60 Min
Product Id: 706896
In this webinar participants will learn the specific steps for building or improving remote and hybrid mentorship programs. They will also learn about the essential elements of engaging and successful remote and hybrid mentorships.

How to Prepare an Effective Audit Manual for an Internal Audit Department
Marna Steuart
60 Min
Product Id: 703684
This webinar will instruct attendees on how to develop an internal audit manual and offer start to finish instructions and templates on how to perform different types of audits given the project description. Audit fieldwork, audit reporting and follow-up, work-paper filing, and project closure are some of the other areas the webinar will cover.

Useful Statistical Methods for Defining Product and Process Specifications - Part II
Steven Wachs
75 Min
Product Id: 706898
This webinar covers useful and important statistical methods that assist scientists and engineers in the development of appropriate product and process specifications. Appropriate product specifications are critical to achieving adequate and reliable product performance.

How To Create an Effective Export Control Compliance Program under the Export Administration Regulations in 2023
Douglas Cohen
60 Min
Product Id: 703983
This training program will assist attendees in establishing and enhancing an export compliance program and offer best practices for export compliance given under the Export Administration Regulations (EARs).

GAMP Data Integrity 21 CFR Part 11 Training Course
Kelly Thomas
90 Min
Product Id: 706912
This course will cover data integrity, electronic records and signatures, and the compliant operation of GxP Computerized Systems to provide the tools and techniques to implement proper controls for data to ensure the integrity and validity of the information throughout the data lifecycle.

Beneficial Ownership Requirements for a Legal Entity
Doug Keipper
60 Min
Product Id: 706905
This webinar will review the CDD Rule and the new requirements issued by FINCEN, along with sharing information and procedures for the beneficial ownership rule.
Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR
David Nettleton
90 Min
Product Id: 701687
This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach).

Usability Principles for Medical Devices: Interpreting and Implementing IEC 62366
John E Lincoln
90 Min
Product Id: 706879
This webinar will provide valuable guidance to regulated companies in development and implementation of Use Engineering / Human Factors Engineering using the 9 stage model in IEC 62366-1. IEC 62366-2 on recommended implementation considerations will be briefly considered, with the focus on IEC 62366-1, the basic methodology. the webinar willshow when and how these tools are incorporated into R&D design control, risk management, validation, root cause analysis, CAPA / falure investigations, GMP auditing, and liability reduction. Unlike risk management, use engineering may not always be necessary, depending upon the user interface under review. Use engineering is designed to reduce product risk, increase intuitive product use, reduce liability, and less chance of recalls.

Risk Management and The New General Chapter, USP<60>, Burkholderia cepacia
Barry A Friedman
90 Min
Product Id: 706907
The Objective of this live, interactive training webinar is to explore the various issues surrounding the history of B. cepacia and its Complex and examine solutions to common microbiological problems. It will discuss the General Chapter USP<60> which was issued December 2019, media that is used, as well as consider recalls, FDA 483s and Warning Letters. The webinar will also review why 16S rRNA identification will not work satisfactorily with this Complex. Please plan to bring an interdisciplinary team to this Webinar to explore how knowledge regarding this contaminant may assist you in your facilities and minimize it as an Objectionable microorganism.

Accident/Incident Investigation and Root Cause Analysis
Joe Keenan
60 Min
Product Id: 706903
This webinar course will cover all of the steps necessary in identifying how to properly conduct a workplace accident/incident investigation to drive to the root cause.

Wage Payment Irregularities/ Dealing with Disruptions in the Payroll Process
Patrick A Haggerty
90 Min
Product Id: 706901
This webinar provides overview of common problems encountered in payroll and methods for prevention, mitigation and resolution. The discussion will include when use of specific forms may be required, such as Form 941-X, Adjusted Employer's Quarterly Federal Tax Return or Claim for Refund and Form W-2C, Corrected Wage and Tax Statement. Special procedures related to fringe benefit withholding, deceased employee wages and misclassified employees will be covered.

Impact Assessment for Change Control
Alan M Golden
60 Min
Product Id: 706337
Attend this webinar to learn the importance of doing a complete impact assessment prior to implementation of changes under change control. Tools and techniques will be presented to aid in organizing and streamlining impact assessments.

Normality Testing: Applications and Issues
Steven Wachs
90 Min
Product Id: 706899
This webinar discusses applications of normality testing and several issues that may arise when testing data for normality. Several methods for testing data for normality are presented. We discuss some of the common types of goodness-of-fit tests that may be used (e.g. Andersen-Darling, Kolmogorov Smirnoff, etc.). We also discuss common reasons that normality tests are rejected.

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.

Introduction to Enterprise Risk Management
Dev Strischek
60 Min
Product Id: 706866
This course covers the basic concepts of Enterprise Risk Management and key elements that finance executives and personnel need to be aware of when implementing ERM across their organizations.

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.

Trial Master File and Clinical Data Management Regulated by FDA
Carolyn Troiano
60 Min
Product Id: 705360
This FDA compliance training will cover in detail the new requirements for trial master files including documents related to clinical trials that are required to be prepared, collected and maintained as part of the TMF.