
Conducting Your 2025 Annual ACH Rules Compliance Audit - a Step-by-Step Guide
Donna K Olheiser
90 mins
Product Id: 705082
The Nacha Operating Rules and Guidelines require that all participating depository financial institutions (ODFI & RDFI), Third Party Senders (TPS) and Third-Party Service Providers (TPSP) that provide ACH services to the RDFI or ODFI, conduct an annual ACH audit by December 31 of each year (Nacha Operating Rules, Article 1).

Conducting and Documenting Robust Investigation for OOS Results
Joy McElroy
90 Mins
Product Id: 707016
The FDA sites hundreds of companies each year for not adequately performing and documenting out of specification results. This course is designed to provide instruction on how to thoroughly document and investigate out of specification results using approaches which have been recommended by regulatory authorities.

21 CFR Part 11, FDA’s Guidance for Electronic Records and Electronic Signatures
Carolyn Troiano
90 Mins
Product Id: 707014
The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.

Drug, Device and Combination Product Development
John E Lincoln
90 Mins
Product Id: 707015
This webinar provides a basic overview of the stages of development and V&V of the basic categories of medical products, from R&D through Production, and the US FDA regulatory and documentation requirements at the various stages.

USP <61>/<62> Microbiological Enumeration and Examination of Non-Sterile Products – Understanding the Current Standards for the Revised USP and Harmonized EP Microorganisms
Barry A Friedman
90 mins
Product Id: 706883
The objective of this live, interactive webinar is to explore the changes to these historic USP test methods, compare them to the new European Pharmacopoeia (EP), 2.6.12 Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests and 2.6.13 Microbiological Examination of Non-Sterile Products: Test for Specified Microorganisms, methodology and how it impacts the typical cGMP microbiological laboratory.

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.
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.

Stability Studies and Estimating Shelf Life
Steven Wachs
90 Mins
Product Id: 706026
The webinar will provide useful methods and techniques for conducting a stability study and analyzing the resulting data for the purpose of estimating shelf life. Participants should be able to immediately apply the methods presented. Also, the interpretation and communication of results will be stressed and illustrated in several examples.

Hypothesis Testing, P-values and Inference: When Thinking like a Statistician Makes Sense
Elaine Eisenbeisz
120 Mins
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.

Fair Lending in 2025: new regulations, examinations and enforcement
Justin Muscolino
60 Mins
Product Id: 707017
Are you as knowledgeable in the Fair Lending regulations? Do you know how they pertain to your role and responsibilities? Has your compliance program changed with the changes in regulations? During this webinar we will go through each of the regulations that fall under Fair Lending and take look at the latest developments in regulatory compliance.

Ethylene Oxide and Gamma Radiation Sterilization Validations
John E Lincoln
90 Mins
Product Id: 707018
Gamma and EO Sterilization verification and validations under the U.S. FDA and EU's EMA / MDR requirements

Current Trends in FDA Inspections
Michael Ferrante
90 Mins
Product Id: 703485
This webinar will focus on the current trends in FDA inspections and guidelines that can be implemented to ensure compliance with the latest quality and regulatory requirements. Attendees will learn how to prepare for an FDA inspection to avoid Warning Letters.

Preparing for Pre-Approval Inspections
Joy McElroy
90 Mins
Product Id: 707019
A pre-approval inspection (PAI) is performed to provide the Food and Drug Administration (FDA) assurances that a manufacturing site named in a drug application is capable of consistently manufacturing a safe drug product, and that the submitted data is accurate and complete against what was filed in their application. This training will provide guidance on when the FDA performs pre-approval inspections. It will describe how to prepare for a PAI, and the outcomes of pre-approval inspections.

Conducting an ACH Risk Assessment and Developing an Effective Risk Management Program
Donna K Olheiser
90 Min
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.

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.

Clinical Trial Systems: The Trial Master File (TMF) and Electronic Trial Master File (eTMF)
Carolyn Troiano
90 Min
Product Id: 706938
Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements. Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction, this body of information may be stored in a trial master file (TMF). All of the data and documents supporting the planning, conduct and evaluation of a clinical trial must be of the highest integrity, which must be maintained through their entire life cycle. Computer System Validation will be discussed as a key methodology for meeting all of these requirements and assuring data/document integrity.
Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR
David Nettleton
90 Mins
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).

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.

Process Capability for Normal and Non-Normal Data (Focus: Process Stability, Capability and Cp, Cpk, Pp, Ppk, Cpm)
Steven Wachs
75 Mins
Product Id: 705020
This webinar discusses methods for estimating process capability for both normal and non-normal data. Methods include estimating the proportion of defective products that may be produced as well as the calculation and use of common process capability indices (e.g. Cpk and Ppk). Process Capability assessments are discussed in the overall context of quality improvement/management.
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.