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) .
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.
BSA/AML Crooks, Thieves and Red Flags
Doug Keipper
90 Min
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.
Harmonized Tariff Schedule Classification
Jan Seal
90 Min
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.
CMS Two Midnight Rule
Laura Ostrowsky
90 Min
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.
Data Integrity Compliance for Computer Systems Regulated by FDA
Carolyn Troiano
90 Min
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.
Power Analysis for Sample Size Calculations
Elaine Eisenbeisz
120 Min
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.
Guidelines for Performing a Corporate Wide Internal Audit Risk Assessment
Marna Steuart
75 Min
Product Id: 703775
Performing a corporate wide risk assessment is doable, and can provide internal audit and its organization a roadmap for the upcoming audit year. In this webinar, participants will learn how to maximize the time spent on the risk assessment process on an annual basis.
Challenging the Complexity of Title V Air Permitting: Best Practices
Joe Keenan
90 Min
Product Id: 705189
The webinar will discuss how to evaluate if a Title V Air Permit is required at your facility and how to properly fill them out. After the webinar the attendees will have a good general outline of what is required in a Title V Air Permit, how to go about getting the information to fill it out, and a comprehensive question and answer session.
Principles for the Management of Operational Risk
Stanley Epstein
90 Min
Product Id: 702286
This webinar highlights the evolution of operational risk management. The principles outlined in the Bank for International Settlements (BIS) report are based on best industry practice, supervisory experience and cover three overarching themes: governance, risk management and disclosure. We will look at the practicality of these principles and the implementation factors with each of them.
Bacterial Endotoxin Test to Include the Latest on Low Endotoxin Recovery (LER)
Barry A Friedman
90 Min
Product Id: 705433
The webinar will review the current testing requirements as defined in the new, revised FDA guidance on Endotoxin and Pyrogen testing. It will further help attendees understand the issues surrounding the Low Endotoxin Recovery (LER) and its regulatory outcome.
USMCA Rules, Procedures and Documentation
Jan Seal
90 Min
Product Id: 705498
This webinar will help attendees understand how to meet the rules that are required to qualify their imports/exports between the three USMCA countries (United States, Canada, and Mexico). In addition, this webinar will present some of the major changes between the NAFTA & the USMCA and how these changes may affect the qualification of your products. Some of these changes may impact your company and require advance preparation to meet compliance requirements.
Pharma Regulatory Submissions Know how – Training Bundle
Robert J Russell,Karl M. Nobert
9 Hrs
Product Id: 706843
Become Specialized with Advertising, Promotion, and Labeling FDA Compliance – Training Bundle
Peggy Berry,Michael Esposito
4 Hrs
Product Id: 706842
Pharmaceutical Regulations Training Bundle for Regulatory Affairs Professionals
Joy McElroy,Karl M. Nobert
7 Hrs
Product Id: 706841
Project Management Training for Pharmaceutical Regulatory Affairs
Pam Dellea Giltner,John E Lincoln
6 Hrs
Product Id: 706840
FinCEN’s CDD Rule and the impact of the AML Act of 2020
Jim George
60 Min
Product Id: 705602
The FinCEN has issued substantial new AML requirements focused on a major expansion of Know Your Customer into what is now Customer Due Diligence, CDD. This webinar will present various aspects of the requirements.
How to Read and Understand an Annual Report
Miles Hutchinson
90 Min
Product Id: 706814
Accounting and finance is supposed to be the international language of business. If so, then why do we struggle so much to make sense of the numbers? Are we so busy managing our business and leading our staff, that we don’t have time to wade through the financials, discover the trends, draw proper conclusions and take appropriate action? What if our peers, or worse, our competition understands our numbers better than we do? In this session, Miles Hutchinson, experienced accounting and finance expert and business adviser, will explain how to quickly and introduce you to the financial reporting of public and private companies!
Hypothesis Testing, P-values and Inference: When Thinking like a Statistician Makes Sense
Elaine Eisenbeisz
90 Min
Product Id: 703552
This clinical research webinar will explore the reasoning that formulates null hypotheses and turns researchers’ hair gray. Attendees will learn the why and how of the scientific method and how to view the world with a statistician’s eyes. Also attendees will learn the possibilities and limitations of research questions and hypothesis development, how to interpret statistical findings with p-values, effect sizes, and confidence intervals.
Personal and Business Tax Returns Analysis - 1040 Federal Tax Returns, K-1 Forms and Tax Code Updates
David L Osburn
90 Min
Product Id: 705011
This personal and business tax returns analysis training program will focus on key areas such as 1040 federal tax returns, K-1 forms, and tax code updates and how they affect bank’s clients. It will also discuss the structure of a C corporation, S corporation, and Partnership (including LLC) tax return.