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NEW Nacha Operating Rules Changes for 2024 PLUS Changes Coming in 2026 – Part 2
Donna K Olheiser
90 Min
Product Id: 706981
Part 2 – Effective March 20, 2026, two Rule amendments (Fraud Monitoring – Phase 1) – monitoring for Faud (as part of a larger Risk Management package) intended to reduce the incidence of successful fraud attempts and improve the recovery of funds after frauds have occurred.
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GMP Environmental Monitoring for Pharmaceutical Clean Rooms
Roger Cowan
60 Min
Product Id: 705783
This webinar will discuss various US and international regulatory requirements, testing requirements for environmental monitoring program, current air and surface monitoring for measurement of no-viable particulate, microbial contamination, contamination due to personnel (gowning techniques and aseptic practices), ongoing monitoring practices with reference to sampling frequency, sampling locations and investigation of action level excursions and monitoring data.
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Trial Master File and Clinical Data Management Regulated by FDA
Carolyn Troiano
60 Min
Product Id: 705360
This FDA compliance training will cover in detail the new requirements for trial master files including documents related to clinical trials that are required to be prepared, collected and maintained as part of the TMF.
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FLSA White Collar Exemptions
Patrick A Haggerty
90 Min
Product Id: 706792
This session will review the current Department of Labor regulations as they apply to the white collar exemptions to the minimum wage and overtime requirement of the Fair Labor Standards Act (FLSA). The tests for exemption are the salary basis test, minimum salary requirement, and the duties tests. These tests have changed over the years and are complex and can be confusing. In addition, there are strict record keeping requirements and salary integrity requirements to prevent disqualification of the exemption. The webinar will also describe proposed changes to the rules and how employers can prepare for the changes.
Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR
David Nettleton
90 Min
Product Id: 701687
This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach).
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The 510(k) Mod Program, Breakthrough Technologies, and STeP
John E Lincoln
90 min
Product Id: 706976
What are the U.S. FDA's recently expanded, less traditional / modified pathways for novel technologies or safer products to receive clearand or approval.
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Terminally Sterilized Pharmaceutical Products – Parametric Release ( New USP<1222>, November 2019) and its Relationship to the new British Terminal Steriliation Methodology (March 2019)
Barry A Friedman
90 Min
Product Id: 706908
This General Information Chapter (USP<1222>) will first cover the general issues related to parametric release, regardless of the modes of sterilization, and then discuss some specific modes of sterilization. It will also include information on USP<55> Biological Indicators as well as EU “Guideline on the Sterilization of Medicinal Products…” (March 2019). The webinar will discuss why it provides more accurate information than the sterility test regarding the release of terminally sterilized product to the marketplace.
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Technical Writing for Medical Devices
Joy McElroy
120 Min
Product Id: 706379
This technical writing training program will offer attendees an understanding of how the reporting process supports products in the medical device industry. This virtual session will highlight the mandates for documentation set forth by the regulators, such as the FDA, ISO, and other governing bodies. The program will train attendees on effectively reviewing and revising documents and assessing your audience, in effect producing effective written correspondence.
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Process Validation Requirements & Compliance Strategies
Jose Mora
60 Min
Product Id: 700162
This Process Validation Requirements webinar will review process validation basics, with emphasis on looking beyond compliance towards achieving a robust process. Review of process validation basics, with emphasis on looking beyond compliance towards achieving a robust process.
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Conducting an effective Regulatory Examination
Justin Muscolino
60 Min
Product Id: 706983
Are regulatory examinations keeping you up at night? In the world of financial institutions, staying ahead of the regulatory curve is more critical than ever.
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Essentials of Successful Fraud Risk Management
Daniel Clark
60 Min
Product Id: 706984
"Essentials of Successful Fraud Risk Management" is a session all about fraud. We begin by defining exactly what fraud looks like and provide a brief history of frauds impact to financial services.
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Tax Evasion, Tax Fraud and Writing an Effective SAR Narrative
Doug Keipper
90 Min
Product Id: 703110
Tax Evasion and Tax Fraud are at the cornerstone of an effective BSA/AML compliance program. Effective monitoring and proper understanding of the topic are required to accurately describe the transactions on a Suspicious Activity Form. This presentation will address the types of transactions and give you examples of how to drill down further to assess those risks.
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Dietary Supplements' CGMPs, 21 CFR 111
John E Lincoln
90 Min
Product Id: 706360
What are the U.S. FDA's requirements for marketing and selling dietary supplements / nutraceuticals in the US, including their QMS per 21 CFR 111.
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Decision-Making and Human Error Prevention
Ginette M Collazo
90 Min
Product Id: 706986
Embark on a transformative journey to enhance your decision-making skills and fortify your ability to prevent human errors with our comprehensive course on "Decision-Making and Human Error Prevention." In today's complex and fast-paced world, the ability to make sound decisions and minimize the risk of human error is crucial across various professional domains.
Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance
David Nettleton
75 Min
Product Id: 701582
Learn how to use Microsoft Excel spreadsheets for GXP data to ensure compliance with 21 CFR Part 11 and reduce validation cost and time.
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Social Media Compliance for Fair Lending: What to post and what not to
Justin Muscolino
60 Min
Product Id: 706987
Ensure compliance in your social media marketing efforts with our "Social Media Compliance for Fair Lending" training. Learn what content is permissible and what's not to avoid potential regulatory issues. This course covers guidelines for posting on various social media platforms while adhering to fair lending laws. Gain insights into creating compliant content that promotes transparency and fairness in your lending practices. Equip your team with the knowledge needed to navigate the complexities of social media compliance, mitigate risks, and maintain regulatory adherence in your digital marketing strategies.
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Writing Effective IQ, OQ,PQ Protocols for Equipment Qualification
Joy McElroy
90 Min
Product Id: 705763
This equipment qualification webinar will discuss the requirements for IQ, OQ, and PQ protocols. It will train about the various components of each protocol, Proper language for documenting qualification testing including how to Collect data, conduct tests, and obtaining all necessary documents.
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Document the Clinical Evaluation Report (CER) for the EU MDR and CE Mark
John E Lincoln
90 Min
Product Id: 706985
To document the clinical evaluation of a medical device and its output, a Clinical Evaluation Report or CER has to be compiled. The CER is an ongoing compilation of the generation, appraisal, and analysis of clinical data related to a device. It is one of the major components of the Technical Documentation File.
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Acceptance Sampling Plans for Process Validation and Production Lot Monitoring
Steven Wachs
90 Min
Product Id: 704315
This webinar provides details regarding the generation of acceptance sampling plans often used in process validation and production control to ensure quality of final products. By attending this webinar, participants will be able understand the key inputs and issues involved in determining acceptance sampling plans. Sampling plans for attribute data are the primary focus although variable acceptance sampling plans are presented as well.
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Reconciling/Adapting the 8D Problem Solving Process for the Life Sciences
Charles H Paul
90 Min
Product Id: 706939
The 80 problem solving process developed by the Department of Defense and driven by Ford Motor Company is a worldwide method used to improve quality address customer complaints and issues quickly and efficiently. The process helps develop rapid response to customer issues and complaints and strengthens business relationship with those customers and regulatory bodies. The process helps improve quality and supports and promotes prevention rather than simply the detection of problems.