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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.
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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.
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Pharma Regulatory Submissions Know how – Training Bundle
Robert J Russell,Karl M. Nobert
9 Hrs
Product Id: 706843
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Become Specialized with Advertising, Promotion, and Labeling FDA Compliance – Training Bundle
Peggy Berry,Michael Esposito
4 Hrs
Product Id: 706842
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Pharmaceutical Regulations Training Bundle for Regulatory Affairs Professionals
Joy McElroy,Karl M. Nobert
7 Hrs
Product Id: 706841
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Project Management Training for Pharmaceutical Regulatory Affairs
Pam Dellea Giltner,John E Lincoln
6 Hrs
Product Id: 706840
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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.
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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!
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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.
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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.
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Documentation and Medical Writing Training for Pharmaceutical Regulatory Affairs Professionals
Peggy Berry,John E Lincoln
7 Hrs
Product Id: 706839
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Best Practices of Drug Development & Safety, Clinical Trials & Clinical Research - Training for Quality Assurance
David Lim ,Laura Brown
13 Hrs
Product Id: 706837
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How to Prevent cGMP Violations & Warning letters - Training for Pharma Manufacturing
Peggy Berry,David L Chesney,Mark Powell
8 Hrs
Product Id: 706838
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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
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Medical Device Registration and Regulatory Submissions Know How for RA Professionals - Training Bundle
Daniel O Leary,Mercedes Massana,Cheryl Wagoner
11 Hrs
Product Id: 706835
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Project Management for Medical Device Regulatory Affairs - Training Bundle
John E Lincoln,Edwin L Bills,David Dills
6 Hrs
Product Id: 706834
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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.
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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.
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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.
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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.