WEBINARS

 

Compliance Training Webinars for Regulated Industries

Overview of the Financial Aspects of Clinical Research

webinar-speaker   Mary Veazie

webinar-time   120 Min

Product Id: 706778

The financial processes supporting a clinical research study is arguably the most important aspect of the study’s life cycle. Without an understanding of clinical research finance, organizations and individuals can unknowingly violate federal regulations and subject the organization participating in clinical research activities to fines, penalties and lost of reputation. This course will provide attendee with an overview of the federal regulations and guidelines governing the financial aspect of clinical research.

Recording Available

 

Investigation of Out-of-Specification Test Results

webinar-speaker   Paul Larocque

webinar-time   90 Min

Product Id: 706638

Attendees will learn the FDA expectations when investigating out-of-specification and out-of-trend laboratory results.

Recording Available

* Per Attendee $299

 

IT Auditing - Principles and Practices for Executives and Directors

webinar-speaker   Robert Davis

webinar-time   60 Min

Product Id: 702560

This IT Audit webinar facilitates an executive-level understanding of the ISACA IT Auditing Standards associated with performing IT assurance services and accepted areas of risk for most organizations through exposure to The Davis Adaptive IT Auditing System and Governance Tree frameworks. Webinar presents guidance following the general structure of planning, studying, testing, reporting, and follow-up. This structure can be applied broadly, or narrowly, defined IT audits.

Recording Available

* Per Attendee $199

 

I-9 Audits: Strengthening Your Immigration Compliance Strategies in 2022 and Beyond

webinar-speaker   Diane L Dee

webinar-time   90 Min

Product Id: 705895

In this webinar, you will learn how to properly complete I9s, conduct internal audits of their I9s, the proper procedures for correcting errors & omissions, retention rules, and how to prepare should they be audited by ICE. It is a violation of Federal immigration law for any employer to knowingly hire employees who are not authorized to work in the United States. The Federal Form I-9: Employment Eligibility Verification, is used by employers as a record of their basis for determining the eligibility of an employee to work in the U.S.

Recording Available

* Per Attendee $249

 

AML/BSA Fundamentals, Compliance, and the AML Act of 2020

webinar-speaker   Jim George

webinar-time   60 Min

Product Id: 705521

Money laundering continues to be a national concern. High levels of drug-related activity and violence have drawn additional attention. Terrorist activities need to be considered as well. Perpetrators have adapted to banks’ efforts so banks cannot combat the money laundering with yesterday’s methods. Software is widely installed to identify specific patterns and “unusual” transactions. But the launderers know this and are constantly striving to create new patterns where their transactions are designed not to be flagged. Like in a game of chess, the advantage goes to the side that thinks the most moves ahead. The AML Act of 2020 lays out some new directions for Federal actions but it will impact Banks due to changes in Customer Due Diligence and whistleblower rewards.

Recording Available

* Per Attendee $229

 

Advanced Risk Analysis Techniques

webinar-speaker   Richard Cascarino

webinar-time   60 Min

Product Id: 702722

Corporations are facing more risks in the expanded environment of business. This webinar will provide auditors and audit management with advanced approaches to risk management and internal risk assessment at a corporate level.

Recording Available

 

Supplier Quality Remediation using Principles of Lean Documents and Lean Configuration

webinar-speaker   Jose Mora

webinar-time   90 Min

Product Id: 706777

Based on lean manufacturing and documentation concepts, this webinar deconstructs the supplier quality remediation process.

Recording Available

 

W-2 and Form 941 Corrections COVID Updates

webinar-speaker   Patrick A Haggerty

webinar-time   90 Min

Product Id: 706776

Penalties for late filing or filing incorrect W-2 Forms are on the rise. In addition, penalties for incorrect information on Form 941 can also be costly. This webinar will discuss methods for avoiding or correcting errors on Forms 941 and W-2 with a focus on how to make corrections where required so that penalties are eliminated or minimized. The webinar will discuss the preparation of Forms 941-X and W-2c correctly and highlight how and when to file the corrections. Correcting or amending returns for the 2020 and 2021 COVID-19 tax credits and tax deferrals will be covered

Recording Available

 

Strategies for Substantiating Structure-Function Claims for Dietary Supplements in the United States

webinar-speaker   Travis Austin MacKay

webinar-time   60 Min

Product Id: 706585

Dietary Supplement companies must ensure that any product claims they make are “truthful and not misleading” under FDA and FTC regulations. To meet these standards, the FTC has stated that claims must be substantiated by “competent and reliable scientific evidence.” This course provides strategies to: 1) identify claims; 2) characterize/rank claims; and 3) determine the level of scientific evidence needed to substantiate different types of claims.

Recording Available

* Per Attendee $229

 

FDA FSMA Preventive Controls Inspection Hot Buttons for 2022

webinar-speaker   Gina Reo

webinar-time   60 Min

Product Id: 705949

This course will look at the new FDA direction and other programs aimed at transforming food safety in 2022 and beyond, including how to manage #483 violations for non-compliances.

Recording Available

 

21 CFR Part 111 - Master Manufacturing Records and Batch Production Records

webinar-speaker   Andy Swenson

webinar-time   60 Min

Product Id: 706762

The single most critical document in an FDA inspection is the master manufacturing record and associated batch production record. While the 21 CFR Part 111 regulations have a checklist of elements the documents must contain, it can be difficult to translate that into a working document. This training will review the basic principles of what an MMR & BPR must contain and give you tools to create an “FDA Acceptable” document.

Recording Available

 

Human Error Reduction Techniques for Floor Supervisors

webinar-speaker   Ginette M Collazo

webinar-time   90 Min

Product Id: 706137

Attend this course to gain practical approaches for supervision on the floor, strategies to get your group in sync and approach issues in GMP related environments by using a specific methodology to correct, prevent and avoid re-occurrence of these issues.

Recording Available

* Per Attendee $249

 

Calculations for Process and Product Capability

webinar-speaker   Elaine Eisenbeisz

webinar-time   90 Min

Product Id: 706629

Attendees of this webinar will learn specific concepts and formulas commonly used to measure the ability of a process to produce output within customers’ specification limits. The focus of this webinar is on providing the information needed for attendees to know the appropriate measures and formulas to use for the various types of process data (attribute or variable).

Recording Available

* Per Attendee $249

 

Good Documentation Practice and Record Keeping Regulations (FDA & EMA)

webinar-speaker   Dr. Afsaneh Motamed Khorasani

webinar-time   60 Min

Product Id: 705583

In this webinar, we will discuss the definition, purpose, importance of GDP, General rules of GDP, GDP as it applies to laboratory notebook documentation, US Pharmacopeia General Chapter <1029>, and introduction “Good Documentation Guidelines”. We will also briefly introduce you to the European Union (EU) GDP, and its enforcement along with some observation samples from FDA.

Recording Available

* Per Attendee $299

 

Pharmaceutical Water System: Design, Testing and Data Management

webinar-speaker   Charity Ogunsanya

webinar-time   90 Min

Product Id: 705863

In this pharmaceutical water system webinar attendees will learn how to design, validate and maintain the new and existing water systems used in drug product manufacturing process. Different types of routine tests, testing frequencies, actions in each tests and sampling procedures associated with pharmaceutical water systems will be discussed to avoid any water systems failures.

Recording Available

* Per Attendee $299

 

Clinical Research Revenue Cycle: Bridging Health Systems and Clinical Research

webinar-speaker   Mary Veazie

webinar-time   120 Min

Product Id: 706775

Clinical research revenue cycle (CRRC) is an integral part of a clinical research portfolio. It is a complex environment that bridges a health systems revenue cycle with clinical research activities. Health systems involved in clinical research activities struggle with effectively incorporating these two environments. In this course, attendees will learn framework for an effective and compliant CRRC program.

Recording Available

 

Red Flags of Money Laundering

webinar-speaker   Doug Keipper

webinar-time   60 Min

Product Id: 703417

This webinar will explain what money laundering is, various types of money laundering including structuring, micro-structuring and cuckoo smurfing. Attendees will learn how to identify the red flags of money laundering in an account within your institution.

Recording Available

* Per Attendee $249

 

Best Practices for Preparing for an FDA Inspection

webinar-speaker   Susanne Manz

webinar-time   90 Min

Product Id: 706774

Are you ready for the FDA to knock on your door? Although an effective Quality System should always be inspection-ready, many medical device companies make basic mistakes during inspections leading to 483s and even warning letters. This webinar can help you manage inspections efficiently and effectively. A professional, polished, responsive approach sets a good tone for an inspection. You will learn how to present information about your quality system in the most competent and professional manner.

Recording Available

 

Payroll Tax Update and Filing of W-2 and W-4 for 2020: Preparing for January 2021 Deadline

webinar-speaker   Miles Hutchinson

webinar-time   90 Min

Product Id: 705831

In this webinar attendees will learn current law and regulations regarding the preparation of Forms W-4 and the filing of Forms W-2 and will provide practical guidance in these areas that have become the subject of increasing IRS scrutiny. It will cover topics related to how to report cost of employer sponsored health coverage, How to handle expense reimbursements made to employees, process to efficiently execute an electronic W-4 program, requirements of Electronic filing with the SSA using Business Services Online (BSO).

Recording Available

* Per Attendee $249

 

How to Survive a DEA Inspection Series - For Manufacturers of Controlled Substances

webinar-speaker   Carlos M Aquino

webinar-time   90 Min

Product Id: 705164

This training covers DEA record-keeping and security topics that a DEA registrant must comply with when handling controlled substances. The focus is elements of what occurs during that unannounced inspection and the auditing methods.

Recording Available

* Per Attendee $299

 

 

 

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