Design Control / Ddesign and Development Requirements / Documents Under 21 CFR 820/ ISO 13485 7.3
John E Lincoln
90 Mins
Product Id: 706923
Proper adherence and documentation of the FDA's Design Control requirements are key to any medical product project's success.
NEW Nacha Operating Rules Changes for 2026
Donna K Olheiser
Product Id: 707025
The Nacha Operating Rules are constantly changing and starting with 2026, there are Minor Topics Rules Changes (3 of them), clarifying language and meanings while having little or no impact to ACH participants.
Third Party Senders – Roles & Responsibilities according to the Nacha Operating Rules!
Donna K Olheiser
90 Mins
Product Id: 706803
This session will help the attendee to identify a Third-Party Sender (TPS) and a “nested” TPS. In addition, we will cover the details needed in the agreements between all parties and what parties based on their role. Discussion on the registration requirement for both the TPS and the nested TPS and what that means to the ODFI.
US FDA Medical Device QSR (21 CFR 820) / Quality Management System - current and proposed major changes
John E Lincoln
90 Mins
Product Id: 706950
The US FDA/CDRH is proposing to harmonize the current Quality System Regulation (QSR) for medical devices (21 CFR 820) by converging its requirements with requirements used by many other regulatory authorities. ISO 13485, into a new device Quality Management System Regulation (QMSR).
Using a Learning Management System (LMS) to Develop Pharma Training Curricula
Michael Esposito
90 Mins
Product Id: 707006
Learn how to use Learning Management Systems (LMS) to create effective pharma training curricula and ensure GMP compliance. This webinar delves into the unique challenges of creating intuitive job position curricula, overcoming LMS limitations, and meeting FDA requirements. Discover how to define true pharma curricula, collect job function details, manage complex training needs, and demonstrate compliance during audits. Ideal for professionals looking to optimize training in pharmaceutical environments.
Function, Preparation and Execution of Job Aids in the Pharmaceutical Industry
Michael Esposito
90 Min
Product Id: 707001
Learn how to effectively develop, prepare, and execute job aids in the pharmaceutical industry. This webinar covers the key characteristics of job aids, their purpose, use in training, and their role in qualifying individuals for independent tasks. Understand the importance of document hierarchies, skill checks, and how to train others to deliver job aid training.
You have a BI Positive or Product Sterility Positive - Now What?
Gerry O Dell
75 Mins
Product Id: 703288
This webinar explains what actions should be taken following an unexpected positive result in a sterility test on a biological indicator (BI) during performance qualification or routine testing. It also addresses the actions to take when a test of sterility demonstrates unexpected growth during validation or routine dose audits. The various items that should be investigated to determine the root cause and the follow up to the investigation will be covered.
The New FDA QMSR (21 CFR 820): Transition Strategy & ISO 13485 Alignment
John E Lincoln
90 Mins
Product Id: 706961
The US FDA, a has finally published their QMSR to replace the previous QSR. Implementation deadline is February 02, 2026. The quality Management System Regulation (QMSR) revises 21 CFR 820 to include ISO 13485:2016 (and ISO 9000m Clause 3) by reference. For FDA inspections, no QSIT 2.0 on the way. Instead, FDA inspections will transition to a process aligned with ISO 13485, described in the Medical Device Compliance Program. This is a shift from QSIT’s subsystem model to a process-focused inspection approach, a heavier emphasis on risk management, and a resultant hybrid compliance burden between a company's legacy QSR requirements and new ISO-based expectations of the QMSR.
Cybersecurity and US FDA Requirements
John E Lincoln
90 Mins
Product Id: 706716
Cybersecurity is the art of protecting networks, devices, and data from unauthorized access or criminal use. It is the practice of ensuring confidentiality, integrity, and availability of information.
Conducting an ACH Risk Assessment and Developing an Effective Risk Management Program
Donna K Olheiser
90 Mins
Product Id: 706995
According to the Nacha Operating Rules, financial institutions are required to assess and manage all ACH risks, which includes developing a Risk Management program. Most ACH risk can be mitigated through proper due diligence for all originating customers (KYC) and strict adherence to ACH origination and credit policies, which includes monitoring ACH activity.
How to Prepare and Survive an EPA Audit
Joe Keenan
60 Mins
Product Id: 706857
In this training program attendees will learn the key elements needed to develop a proactive Regulatory Compliance Written Program. After this webinar, you will have confidence in facing the next EPA regulatory compliance audit that comes your way.
Quality Agreements and Their Role as Part of a Quality System
Michael Ferrante
90 Mins
Product Id: 706966
This webinar will focus on the Process for Quality Agreements and requirements that must be implemented to ensure compliance with the latest quality and regulatory requirements. Attendees will learn the reason for implementing a Quality Agreement system to assure adequate controls for Service Providers.
Ethylene Oxide (EO) Sterilization Basics for R&D Engineers
Gerry O Dell
90 Mins
Product Id: 701272
This Sterilization training will provide valuable information to companies that design products for terminal sterilization with ethylene oxide.
BSA Important Issues: new mandates, requirements, and recommendations
Justin Muscolino
60 Min
Product Id: 706975
The Bank Secrecy Act (BSA) is a US law that fights money laundering and other financial crimes. BSA requires businesses to keep records and file reports that are determined to have a high degree of usefulness in criminal, tax, and regulatory matters. Individuals and financial institutions who fail to comply with BSA requirements may face severe penalties and for more serious offenses, prison sentences.
Storm Water Pollution Prevention Plans (SWPPP)
Joe Keenan
90 Mins
Product Id: 705510
This webinar will discuss the basics of what is required in a Storm Water Pollution Prevention Plan (SWPPP), how to develop and implement and formalized SWPPP and address site-specific questions and scenarios.
The New OSHA Recordkeeping and Reporting Requirements-300, 300A, 301
Michael Aust
60 Mins
Product Id: 704465
This webinar training will discuss the recent updates in OSHA Recordkeeping and Reporting Requirements. Speaker will explain the major regulatory changes that went into effect January 1, 2015 Participants will gain valuable understanding of 300, 300A and 301 log, new reporting timeline requirements and exemptions.
Unauthorized Transactions – Reg E vs Nacha Operating Rules
Donna K Olheiser
90 Mins
Product Id: 706856
Unauthorized transactions come in many different forms, when returning using Reg E or the Nacha Operating Rules can be confusing. Discussion will include what, why and when while processing unauthorized returns. The trainer will define the limits of liability and who is liable for what amount while providing some real-life scenarios. Details on the error resolution process with Reg E for consumer notification to the financial institution, research time involved, and the timing of providing provisional credit; included will be guidelines on the “what if” there is no error, and providing notice to consumer, and any overdraft protection relating to that provisional credit being reversed. Included will be outlining the ACH return process, when using the ACH network is appropriate, and paperwork/forms needed. Recent Rules changes affecting Nacha compliance when sending unauthorized ACH Returns using Return Reason Codes R10 vs. R11 is included.
Supply Chain and Product Compliance Using RoHS, REACH, and Conflict Minerals
Kelly Eisenhardt
60 Mins
Product Id: 703871
This training program will offer an in-depth look at three important product regulations focused on materials compliance and ethical sourcing, along with the tools and policies needed to implement them.
Human Error Investigations, Root Cause Determination and CAPA Effectiveness
Ginette M Collazo
90 Mins
Product Id: 704314
This training program will offer attendees an understanding of human error, its factors and causes. The program will also identify the regulatory and business importance of human error prevention and define the process to manage human error deviations.
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.







