Design Control Essentials for Medical Devices - Including Differences between ISO13485:2016 and FDA QSR
Susanne Manz
90 Min
Product Id: 706751
Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your customers. This 90-minute webinar will cover the essentials of design controls for medical devices.
Understanding Environmental Social and Governance (ESG) and its Compliance
Stanley Epstein
120 Min
Product Id: 706763
Environmental, Social, and Governance (ESG) has gained increasing attention over the past few years. Today many institutional investors will only invest in those companies that provide ESG performance reporting. ESG provides a set of standards for a company’s operations that today’s socially conscious investors use to screen potential investments in terms of how a company treats the environment, manages social issues (relationships with employees, suppliers, customers, and the communities where it operates), and deals with governance issues.
Medical Device Software Development Under IEC 62304
Don Hurd
60 Min
Product Id: 706744
ANSI/AAMI/IEC 62304 is a Recognized Consensus Standard by the US FDA and a harmonized standard in the EU. This means that compliance to it provides a presumption of conformity to the requirements within those jurisdictions. Not complying with the standard has shown to lead to longer regulatory review times and frequent rejections.
How to Conduct Successful Supplier Audits
Danielle DeLucy
60 Min
Product Id: 704499
This training program will provide participants with a working knowledge of supplier audits. The why, when, who, how, and what of conducting a supplier audit will be reviewed to ensure that your supplier can meet all your expectations.
Basic and Meaningful Human Resource Metrics
Greg Chartier
70 Min
Product Id: 701696
Learn different HR metrics which can be used across organization to improve performance of human resources
AML/BSA Overview, Compliance, and Current Issues, including new CDD Requirements
Jim George
60 Min
Product Id: 705827
This BSA/AML webinar will discuss various compliance requirements for AML - KYC, CTRs, SARs, new customer due-diligence process and various strategies which money launderers are using now and how to detect and thwart it.
ISO/IEC 17025 And ISO/IEC 17020, Which Is The "Right" Standard for You?
Michael Brodsky
60 Min
Product Id: 706741
Developing a QMS is a prerequisite for getting accredited. ISO/IEC 17020 sets out general criteria for the operation of various types of bodies performing inspection. ISO/IEC 17025 is the international standard for the General requirements for the competence of testing and calibration laboratories. Which is the right standard for you?
Practical Steps to Conducting an ISO 27701 Gap Analysis
Robert Davis
60 Min
Product Id: 706742
Strategically, tactically, and operationally sustaining information technology (IT) confidentiality translates into maintaining assigned information asset privacy levels. Organizations have failed in securing the privacy of personally identifiable information. In response, this presentation addresses information security issues regarding ISO/IEC 27701: 2019 standard integration considering the current organizational privacy protection practices.
Health Canada Regulations on NHP's vs. FDA's Dietary Supplement Regulations
Travis Austin MacKay
60 Min
Product Id: 705497
This online training will offer an overview of what Health Canada considers to be a Natural Health product (NHP) and review Canadian regulatory requirements for Natural Health products. It will compare Canadian requirements with U.S. FDA requirements for marketing and labeling dietary supplements and convey an understanding of how they differ.
Tests of Equivalence and Non-Inferiority
Elaine Eisenbeisz
90 Min
Product Id: 706743
Tests of superiority, using null hypothesis statistical testing (NHST) are the norm in most research settings. However, there are situations where superiority of a treatment to a control is not needed, and sometimes it is not ethical to do so. For example, a researcher may be interested not in superiority, but instead, would like to compare the efficacy of a newer drug with a working treatment (an active control). In this webinar, Elaine Eisenbeisz will introduce types of statistical tests that can demonstrate that two treatments are ‘similar’ to each other in terms of their clinical effectiveness.
Building a World Class Accounts Payable Operation: P2P, AP
Brian G Rosenberg
60 Min
Product Id: 703979
This training program will help attendees examine if their AP department matches world-class standards. Attendees will learn key success factors to an optimal Accounts payable operation. They will also gain in depth knowledge on the must-have technologies for any AP operation and learn how to design processes to fully leverage those capabilities. The webinar will also discuss balancing controls with efficiency and how to create a fraud-proof department. Attendees will learn about the most important metrics for any AP department and how to develop strategies to improve those metrics.
How to write SOP's that Avoid Human Error
Ginette M Collazo
90 Min
Product Id: 704418
This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOP’s to reduce the likelihood of human errors.
Root Cause Analysis - The Heart of Corrective Action
Betty Lane
75 Min
Product Id: 703391
This webinar will discuss how root cause is an essential part of a corrective action system and will provide some examples of how to perform root cause analysis.
Report Writing for Auditing Professionals
Phil Vassallo
90 Min
Product Id: 703814
Skilled auditors require a method that aligns what they experienced during the reviewing process with what they compose during the writing process. This report writing workshop will provide foundation resources that participants can continually turn to during intense, complex audit engagements.
HR Audit: How to Conduct an HR Audit for HR Professionals
Melveen Stevenson
60 Min
Product Id: 706740
Are you confident that your employment, benefits, leaves, and I-9 files are in full compliance with state and federal compliance requirements? If you are pausing to answer this question or if it elicits feelings of dread, join us for an information-packed session that will reduce your risk for being assessed costly fines and being cited for potential violations. In this session, you will learn an organized way to assess your company’s needs for auditing HR files and staying ahead of ever-changing regulations. Special topics include organizing your HR recordkeeping system, auditing FMLA documents and procedures, and auditing I-9 forms and procedures.
Privacy Issues in the Workplace
Bob Oberstein
90 Min
Product Id: 706739
Most employees insist they have privacy rights, especially at the workplace. But few know what those rights are. Likewise, not every employer or manager know what the employer’s privacy rights are or what their obligations are when it comes to respecting an employee’s privacy rights and what the penalties are for not doing so. And that was in a pre-Covid-19 world!
ICD-10-PCS FY2022 Update
Gloryanne Bryant
60 Min
Product Id: 706627
For FY2022 there are 191 new PCS codes! Hospital Coding and CDI professionals need to review key aspects to the Official Guideline changes. Understanding the FY2022 new ICD-10-PCS codes changes and the clinical meaning including new devices and new technology are vital for coding accuracy. Coding personnel must learn coding rules, as well as what documentation is required to submit PCS codes and how they affect the ICD-10-PCS tables.
HIPAA and Business Associates - New Responsibilities and Obligations
Jim Sheldon-Dean
90 Min
Product Id: 702610
HIPAA regulations pertaining to the relationships of business entities that share PHI are now being enforced. HIPAA Business Associates are covered directly under the Privacy Rule’s use and disclosure limitations, the Security Rule’s safeguard provisions, and the Breach Notification Rule’s notification requirements. HIPAA Business Associates are responsible for their own compliance with the regulations, and may be held directly liable for any violations of the regulations. Whether your organization is a Business Associate or a Covered Entity that hires HIPAA Business Associates, you have significant obligations in compliance that you overlook at your peril.
OSHA’s "Top 10" Most Cited Violations FY2020: Are Your Prepared?
Michael Aust
60 Min
Product Id: 706573
Attend this webinar for an in-depth presentation of the "Top 10" most violated standards in the General Industry and Construction Industry. You will learn how to train front-line supervisors and managers on safety issues and employee behavior.
Workplace Unconscious Bias: Minimizing the Impact on Discrimination, Hiring, Promotions, and Retention
Dr. Susan Strauss
60 Min
Product Id: 704876
Unconscious bias has been recognized as a form of discrimination and can therefore lead to lawsuits. This training program addresses the science of unconscious bias and lists the examples and types. The Instructor will discuss the implicit association test (IAT) and steps to minimize individual and organizational unconscious bias in hiring, promotions, and retention.