The 6 Most Common Problems in FDA Software Validation and Verification
David Nettleton
120 Min
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.

Toxic Substance Control Act (TSCA) Awareness Training 101
Joe Keenan
90 mins
Product Id: 706205
Attend this training to understand all the requirements of the Toxic Substance Control Act (TSCA), its revisions, and how to develop a written plan, TSCA Training Plan. Get answers to your TSCA questions.

Effective Systems for Change Control in the Pharmaceutical Industry
David L Chesney
90 mins
Product Id: 705002
This webinar will help you understand GMP requirements for change control from a pharmaceutical manufacturing perspective, the purpose of change control and what types of changes are or are not subject to change control. Participants will learn how to execute and implement a change in a regulated environment.

Strategies to Combat Counterfeit Drugs and Other Supply Chain Threats
Michael Esposito
90 Mins
Product Id: 706067
Counterfeit drugs present a real and increasing danger both to patients and companies and require a proactive approach to stay ahead of them.

AML Regulatory Insight for Q1 2025: Implementing recent changes in your financial institution
Justin Muscolino
60 Mins
Product Id: 707012
As Compliance Officers, we need to be prepared and be able to communicate with those who will be impacted by the upcoming changes. There are several changes coming our way in 2025.

Analytical Methods, Process, Equipment, Cleaning, and Sterilization Validations
John E Lincoln
90 mins
Product Id: 707011
Both the U.S. FDA and EU's MDR expect documented risk-based device test method and design V&V under the GLPs, et al

ISO 13485:2016 Quality Systems
Juan M Campos
90 Mins
Product Id: 707013
Compliance with international standard ISO 13485:2016 is mandatory for all medical devices placed in most of the main markets word wide. It is of strategic importance for any medical device manufacturer to understand and effectively apply the ISO 13485:2016 requirements to access these critical markets.

Power Analysis for Sample Size Calculations
Elaine Eisenbeisz
120 Mins
Product Id: 705873
In this webinar attendees will learn the statistical power analysis and techniques for determining sample size (a priori techniques) calculation. Also attendees will get work examples in the free to use G*Power software. Some code and demonstrations will be provided for powering studies and performing power analysis simulations in R software.

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.

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.
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).