
Major CGMP Issues - US FDA Concerns in 2022
John E Lincoln
90 Min
Product Id: 702185
This webinar will evaluate the chief areas of FDA CGMP and EU compliance inspections to see actual and anticipated changes in emphasis, and how to better prepare with a company's proactive internal inspection / audit program.

HIPAA Audit and Enforcement Update for 2022 - HHS Keeps Pressure on Access, Privacy, and Security Compliance
Jim Sheldon-Dean
90 Min
Product Id: 705026
This webinar will discuss HIPAA audit and enforcement regulations and processes for 2022 and how they apply to covered entities and business associates. Attendees will learn how to prepare for HIPAA audit to avoid fines and penalties for HIPAA violations.

Wage & Hour Laws: Ensuring Compliance with the Fair Labor Standards Act in 2022
Diane L Dee
75 Min
Product Id: 706747
This webinar will lay the groundwork for determining whether your employees are properly classified as Exempt or Non-exempt and ensuring that wage and hour laws are being followed properly.

The New OSHA Recordkeeping and Reporting Requirements-300, 300A, 301
Michael Aust
60 Min
Product Id: 704465
This webinar training will discuss the recent updates in OSHA Recordkeeping and Reporting Requirements. Speaker will explain the major regulatory changes that went into effect January 1, 2015 Participants will gain valuable understanding of 300, 300A and 301 log, new reporting timeline requirements and exemptions.

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.
Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance
David Nettleton
75 Min
Product Id: 701582
Learn how to use Microsoft Excel spreadsheets for GXP data to ensure compliance with 21 CFR Part 11 and reduce validation cost and time.

Critical Anti-Fraud Audits under Procurement and Accounts Payable
Marna Steuart
75 Min
Product Id: 703533
This webinar will explain how to perform anti-fraud audits in the purchasing/accounts payable cycle. It will discuss the use of Audit Control Language (ACL) and how this tool and other tools like it (IDEA) are helpful in the analysis of accounts payable and purchasing data.

Avoidable Delay Management: How to Take Control of Your Length of Stay
Laura Ostrowsky
60 Min
Product Id: 706053
This webinar will help you identify factors that cause delays as patients progress through their stay and how to correct these barriers to care. Learn the most streamlined ways in which to integrate avoidable delay management into your day and with all the members of the interdisciplinary care team. Finally, it will review some examples of report cars that can be used to understand the data you have collected.
SaaS/Cloud Risk-Based Validation With Time-Saving Templates
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).

Compliance with the American with Disabilities Act (ADA): What Employers Need to Know in 2022
Diane L Dee
120 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.

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.

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.

California GIG Worker Protections: Regulating the Relationships between Organizations & Their GIG Workers
Diane L Dee
60 Min
Product Id: 706737
This labor law extended wage and benefit protections to approximately one million California workers and extends employee classification status to gig workers. This law puts tough restrictions on who can be classified as independent contractors or freelancers rather than employees. This webinar will assist participants in making those decisions and thereby avoid the consequences of non-compliance.

Effective Systems for Change Control in the Pharmaceutical Industry
David L Chesney
90 Min
Product Id: 705002
This webinar will help you understand GMP requirements for change control from a pharmaceutical manufacturing perspective, the purpose of change control and what types of changes are or are not subject to change control. Participants will learn how to execute and implement a change in a regulated environment.

User / Human Factors Engineering Under IEC 62366-1, -2
John E Lincoln
90 Min
Product Id: 705111
This webinar will focus on the Key parts of IEC 62366-1:2015 and -2:2016, Human Factors Engineering and Role in Design Control (21 CFR 820.30)l, Design and Development Planning (ISO 13485 7.3) .

How to Construct an HR Center of Excellence
Daniel T Bloom
60 Min
Product Id: 706831
In this webinar you will come to understand the power of the centers of excellence and its relationship to establishing the value of HR to the total organization and to management.

Post Market Surveillance with the new Medical Device Regulation EU MDR 745/2017
Frank Stein
90 Min
Product Id: 706121
This webinar will help you understand the requirements of the new medical device regulation EU MDR 745/2017 and teach you how to create new required reports for the Notified Body and the Competent Authorities and how this process is connected to other processes in the quality management system according EN ISO 13485:2021.

Process for Performing a Vendor/Contract Audit: What Should be Considered and How to Plan, Perform and Report Results of a Vendor Audit
Marna Steuart
75 Min
Product Id: 706219
Attend this webinar to learn about the different contract terms, different ways to determine the scope of the audit given contract terms and conditions, how to plan, perform and report results of a vendor audit.

ACH Government Payment Processing - Handling Death Notification Entries (DNEs) and Reclamations
Donna K Olheiser
90 Min
Product Id: 704540
This 90-minute session will provide the details on what is different and how the Federal Government has adopted the NACHA Operating Rules and what the exceptions to those Rules incorporate for the Federal Government. You will learn what the Green Book is and how this valuable on-line tool will help you with processing DNE’s and Government Reclamations.

Digital Payments 2022 - The future of Payments
Stanley Epstein
120 Min
Product Id: 704753
This webinar examines the current state of the payments industry - from the complexity of the current payments landscape, the growing range of bank and non-bank participants, the ever-increasing range of payments methods, interfaces and systems, open banking, regulation and the future payments scene. We also look at how the COVID-19 pandemic has and will continue to affect payments.