Alan M Golden
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.
Product Id: 703853
FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person’s behavior and decision outcomes. How FDA applies its legal tenants of false and misleading information or variations on that theme requires continual updating by FDA and constant re-evaluation by industry. Now the regulatory landscape involves other federal agencies and academic principles in psychology. It has become very complicated and will prove very costly if you knowingly or unknowing walk into one of FDA’s legal snares. This webinar will bring attendees up to speed so you are clearer about what is a problem, what is not a problem and what becomes a risk laden judgment call.
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.
Diane L Dee
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.
HIPAA Audit and Enforcement Update for 2022 - HHS Keeps Pressure on Access, Privacy, and Security Compliance
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.
John E Lincoln
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.
California GIG Worker Protections: Regulating the Relationships between Organizations & Their GIG Workers
Diane L Dee
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.
David L Chesney
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.
John E Lincoln
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) .
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
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.
Donna K Olheiser
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.
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.
Product Id: 706833
This anti-money laundering training will describe the reasons and methods of money laundering in financial institutions. This will help attendees to protect themselves from regulatory risk by establishing an effective anti-money laundering system within their financial institution. Also this webinar will explain various types of money laundering and how to identify the red flags of money laundering in an account within your institution.
Diane L Dee
Product Id: 706609
Participants in this webinar will learn what constitutes pay equity, the laws governing pay equity, strategies to avoid pay discrimination, and what organizations can do to cultivate a work environment that will lead to more equitable outcomes for their employees.
Product Id: 705224
In this webinar attendees will understand the rules that are required to classify products in the Harmonized Tariff Schedule. Minimize errors in classification and better prepare your company for import/export audits from the government. It will also assist companies who are eligible for free trade agreements, ex. USMCA, and other agreements, in properly completing Certificates of Origin.
Product Id: 705995
The 2 midnight rule is designed to identify the appropriate level of care for short term stays or episodes in acute care, critical access and long term hospitals and to reimburse accordingly. The rule designed to save money by payment through Medicare part B instead of A is seen by many consumers and providers as both unclear and a cost shift from CMS to consumers and providers hence the controversy surrounding this rule. The presentation will provide history, explanation of the rule with both medical and financial outcomes and illustrate with case examples.
Product Id: 706352
Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. In this webinar, you will learn about these FDA trends in compliance and enforcement, as they relate to Data Integrity, and how to improve your practices to meet compliance requirements.
Product Id: 705873
In this webinar attendees will learn the statistical power analysis and techniques for determining sample size (a priori techniques) calculation. Also attendees will get work examples in the free to use G*Power software. Some code and demonstrations will be provided for powering studies and performing power analysis simulations in R software.