Budgeting & Forecasting Basics: Build a Rolling 12 Month Model
Justin Muscolino
60 Mins
Product Id: 707040
This webinar shows how to build and use a rolling 12-month budget and forecast to support real business decisions. You’ll learn how to move beyond static annual budgets and create forward-looking financial models that adjust as conditions change. The session focuses on practical forecasting you can use immediately.
How to Transition from Traditional CSV to CSA: Practical Migration Plan, Templates & Risk Strategy
Carolyn Troiano
90 Mins
Product Id: 707041
The life science industries, including pharmaceutical, medical device, biotechnology, biological, and tobacco and tobacco-related products continue to embrace new technology to improve delivery of quality products in compliance with FDA. In addition, we’ve seen a trend toward making use of cloud services, Software-as-a-Service (SaaS) solutions, and other technical innovations such as use of Artificial Intelligence (AI), Machine Learning (ML) and Large Language Models (LLMs), such as ChatGPT that have more recently begun to be used more heavily in life science companies.
The 6 Most Common Problems in FDA Software Validation and Verification
David Nettleton
120 Mins
Product Id: 705582
This training on FDA software validation and verification will provide you the best practices necessary to ensure that all systems are validated in compliance with FDA regulations.
From P-Values to Evidence: Interpreting Statistical Results in Regulatory Decision-Making
Elaine Eisenbeisz
90 Mins
Product Id: 707042
Statistical significance alone is no longer sufficient to support regulatory claims. Modern regulatory review requires careful interpretation of effect size, confidence intervals, robustness, and clinical relevance. This webinar provides a technically grounded, example-driven approach to interpreting p-values and statistical results in regulatory submissions.
Quality Assurance and Good Manufacturing Practices (GMP) in Drug Production
Charles H Paul
90 Min
Product Id: 706936
Quality Assurance (QA) and Good Manufacturing Practices (GMP) play a critical role in ensuring the safety, efficacy, and quality of drugs during their production. In the pharmaceutical industry, QA refers to the systematic processes and procedures implemented to guarantee that drugs meet the established standards and regulatory requirements. GMP, on the other hand, encompasses a set of guidelines and regulations that govern the manufacturing, testing, and quality control of pharmaceutical products.
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.
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
90 Mins
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.
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.
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.
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.
The Importance of Packaging and Labeling in Pharmaceutical Product Development
Michael Esposito
60 Mins
Product Id: 706063
Packaging and labeling is often underestimated in the planning phases of pharmaceutical product development. This leads to unnecessary increases in cycle time, costly errors, and delays in product availability, or product recalls due to noncompliance. This webinar will help you succeed in pharmaceutical product launch by exploring its importance right from the conception of a product, its realization and distribution.
NEW Reclamation Process - Fed Gov't Payments
Donna K Olheiser
90 Mins
Product Id: 706928
Processing ACH Reclamations from the Federal Government can be challenging! Chapter 5 of the Green Book has been updated making it mandatory for Financial Institutions to respond to all reclamations must be submitted through the Automated Reclamation Processing System (ARPS) located in Treasury’s Pay.gov web portal (except for responses by DFAS and any Treasury-approved exceptions). The Nacha Operating Rules still apply when processing these payments but the Green Book outlines exceptions when handling DNEs (Death Notification Entries) and Federal Government Reclamations. A side-by-side comparison of Commercial vs. Government Reclamations will be included to know what the difference is and how to handle each one.
Latest Changes to RoHS and REACH for 2026
Kelly Eisenhardt
60 Mins
Product Id: 706070
This 1-hour webinar will go into the specifics of the REACH and RoHS regulations and review the latest amendments and changes to both regulations for 2026. We will draw out key developments and key dates (if applicable) with particular emphasis on requirements for US firms.
EPA Tier II Reporting
Joe Keenan
60 Mins
Product Id: 705125
This training program will enumerate the requirements of the Emergency Planning and Community Right-to-Know Act (EPCRA) as it applies to your organization. It will also help attendees understand the threshold trigger for reporting a hazardous chemical on the Tier II forms and learn how to accurately calculate chemical mixtures as it applies to the Tier II forms. Further, attendees will learn to navigate the complexities of online Tier II reporting.
Troubleshooting Ethylene Oxide (EO) Processes
Gerry O Dell
75 min
Product Id: 701679
Not every parameter in the EO sterilization process in critical for the determination of the product’s sterility assurance level (SAL). This presentation will outline the various parameters and what actions should be taken when they are not compliant to the process specification. These actions can be as simple as a rationale for release to as complicated as the need for the qualification of a new sterilization process. How to decide the actions to take will be addressed along with the reasons behind the decisions so that an accurate and complete justification of your decision can be made for both management and regulatory agencies. The rationales for both conventional and parametric release will be addressed.







