
Sample Size Determination for Design Validation Activities
Steven Wachs
90 Mins
Product Id: 705852
Statistical Methods are typically used to ensure that product performance, quality, and reliability requirements are met during the Design Validation phase of product development. This webinar discusses common elements of sample size determination and several specific sample size applications for various design validation activities including Reliability Demonstration/Estimation, Acceptance Sampling, and Hypothesis Testing.

Conducting Effective Quality Audits: Beyond Audit Checklists
Michael Ferrante
60 Mins
Product Id: 703539
This webinar will teach attendees best practices for conducting effective quality audits to ensure regulatory compliance. Learn how to avoid potential pitfalls during the audit process.

Analytical Method Validation and Transfer
Kelly Thomas
90 Mins
Product Id: 706186
This course will provide a thorough review of regulatory guidelines on method validation and transfer. It provides guidance on how to perform QC analytical test method validations and transfers.

Good Documentation Practice (GDP) and FDA Validation Compliance for Regulated Computer Systems and Data
Carolyn Troiano
90 Mins
Product Id: 706925
Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing and distribution of a product in the pharmaceutical, biotechnology, medical device or other FDA-regulated industries. The FDA requirements ensure thorough planning, implementation, integration, testing and management of computer systems used to collect, analyze and/or report data. Electronic records and electronic signatures (ER/ES) came into play through guidelines established by FDA in 1997, and disseminated through 21 CFR Part 11. This code describes the basic requirements for validating and documenting ER/ES capability in systems used in an FDA-regulated environment.

OSHA Inspection Readiness: What to Expect and How to Prepare
Joe Keenan
90 Min
Product Id: 705368
Regulatory compliance audits can be taxing and worrisome for anyone. Having an OSHA, EPA or State Department of Environmental Quality Audit can open an organization up to receiving regulatory citations, monetary fines, negative company press, etc. The purpose of this webinar is to cover the key concepts of how to successfully navigate through a OSHA Audit.

FDA's New Software Validation Requirements
John E Lincoln
90 Mins
Product Id: 706952
CGMP companies must develop / implement formal software V&V for medical product under IEC 62304 and a key US FDA Guidance Document.

Mapping and Review of Pharmaceutical Warehousing and Distribution Workflows
Michael Esposito
90 Mins
Product Id: 707026
Mapping and evaluating all the steps in a pharmaceutical warehousing and distribution workflow can lead to valuable process improvements. In this webinar, we discuss how this review can be accomplished and the possible benefits that can result.

Sanctions: We have an OFAC violation: What to do!
Justin Muscolino
60 Mins
Product Id: 707027
We need to be aware of the Sanctions imposed for others when we conduct our business in financial institutions. Sanctions are penalties or other means of enforcement used to provide incentives for obedience with the law, or with rules and regulations.
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.

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.

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 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

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.

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.

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).

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.

US Market Access & Reimbursement : Medical Devices
Robert J Russell
60 Min
Product Id: 706989
This targeted 60-minute U.S. Reimbursement training/webinar will help you understand and navigate the complex U.S. system for understanding product reimbursement status and potential for your Medical Device

Analytical Method Development, and Method Transfer
John E Lincoln
90 mins
Product Id: 707009
The U.S. FDA and EU's MDR require specific steps to be fulfilled to develop and/or transfer analytical methods to maintain accuracy.

Total Organic Carbon Analysis for Cleaning Validation in Pharmaceutical Manufacturing
Joy McElroy
90 mins
Product Id: 705929
In this cleaning validation webinar attendees will learn the Total Organic Carbon (TOC) feasibility, method validation and transfer from the laboratory to the manufacturing floor, as well as reviewing a feasibility study of multiple, difficult to oxidise or low solubility organic compounds.