
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.

Documentation and Medical Writing Training for Pharmaceutical Regulatory Affairs Professionals
Peggy Berry,John E Lincoln
7 Hrs
Product Id: 706839

Best Practices of Drug Development & Safety, Clinical Trials & Clinical Research - Training for Quality Assurance
David Lim ,Laura Brown
13 Hrs
Product Id: 706837

How to Prevent cGMP Violations & Warning letters - Training for Pharma Manufacturing
Peggy Berry,David L Chesney,Mark Powell
8 Hrs
Product Id: 706838

How to use Quality Systems and Processes - Training for Pharma Quality Managers
Joy McElroy,Dr. Ludwig Huber,John E Lincoln
7 Hrs
Product Id: 706836

Medical Device Registration and Regulatory Submissions Know How for RA Professionals - Training Bundle
Mercedes Massana,Cheryl Wagoner,Ana Maria Saaibi,Eliana Silva de Moraes
4.5 Hrs
Product Id: 706835

Project Management for Medical Device Regulatory Affairs - Training Bundle
John E Lincoln,Edwin L Bills,David Dills
6 Hrs
Product Id: 706834

Incoterms® 2020 Rules
Jan Seal
90 Min
Product Id: 706265
Attend this webinar to learn how to make correct use of Incoterms® to prevent delays and save additional costs. Learn how certain rules determine who is responsible for transportation, insurance, reporting the transaction to customs and much more.

How FDA trains its investigators to review CAPA and what should you do to prepare
Jeff Kasoff
60 Min
Product Id: 700851
This CAPA investigation training will discuss techniques used by the FDA to review your CAPA system. You will learn what the FDA tells their inspectors to focus in the QSIT document and how your company can use the same QSIT document to prepare for inspection.

Performing Effective Management Review of the Quality System
David L Chesney
90 Min
Product Id: 704933
This webinar will teach you how to conduct an effective management review of the quality system which helps you understand how to plan and focus on right metrics and governed by an efficient process. Participants will also understand FDA policy regarding disclosure of management review information during inspections.

Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance
Carolyn Troiano
90 Min
Product Id: 706348
FDA’s recent focus on data integrity during computer system validation inspections and audits has brought this issue to the forefront of importance for compliance of systems used in regulated industries. These include all systems that “touch” product, meaning they are used to create, collect, analyze, manage, transfer and report data regulated by FDA. All structured data, including databases, and unstructured data, including documents, spreadsheets, presentations, images, audio and video files, amongst others, must be managed and maintained with integrity throughout their entire life cycle. It is a risk-based approach that leads to the best results and compliance with FDA’s expectations.

The FDA Inspection Process: From SOP to 483
Jeff Kasoff
60 Min
Product Id: 700269
This is a detailed course designed to provide medical device/pharmaceutical professionals with the information they need to prepare for and manage any type of FDA inspection. This course provides the rationale, strategies and flow on how to plan for an inspection, the inspection process and approach, and which company roles should be assigned for these types of inspections, among other related topics.

ANDA Submission and GDUFA Guidance
Charles H Paul
60 Min
Product Id: 706791
An ANDA is an Abbreviated New Drug Application. This application is submitted to the FDA to seek approval to produce a U.S. generic drug from an existing patented approved drug. The ANDA is submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs. After approval, the applicant is able to produce and market the generic drug product.

21 CFR Part 11, FDA's Guidance for Electronic Records and Electronic Signatures
Carolyn Troiano
90 Min
Product Id: 706563
The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.

The Physician Advisor's Role in Case Management
Laura Ostrowsky
60 Min
Product Id: 705410
This webinar will focus on regulatory requirements, optimal processes and define the difference in collaboration with both internal and external physician advisor roles. It will also discuss the role of the physician advisor and staffing needs to implement this important role.

Excel: Building a Reporting Tool with Pivot Tables and Charts
Mike Thomas
60 Min
Product Id: 705245
Learning how to create Pivot Tables is one of the must have skills for anyone who needs to use Excel to quickly build reports and summaries. This webinar will provide you with a solid foundation that you can use to build your own Pivot tables and reports.

Banking MSBs: BSA/AML Risks, Mitigation of Risks and Rewards
Richard Cascarino
60 Min
Product Id: 705893
In this webinar Banks and Credit Unions (Financial Institutions) will gain a core understanding of the BSA/AML risks, risk mitigation techniques and potential rewards of banking MSBs. This course is designed to assist Financial Institutions in formulating their strategy for banking MSBs, regulatory bodies overseeing MSB compliance, income and expense characteristics in banking MSBs, balance sheet impacts, perceptions and misperceptions of MSBs, risk between MSB entities and how to strengthen your financial institution’s BSA/AML program.