WEBINARS

 

Compliance Training Webinars for Regulated Industries

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Sample Size Determination for Design Validation Activities

webinar-speaker   Steven Wachs

webinar-time   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.

15 / Oct / 2025 - Wednesday

* Per Attendee $199

 

Conducting Effective Quality Audits: Beyond Audit Checklists

webinar-speaker   Michael Ferrante

webinar-time   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.

16 / Oct / 2025 - Thursday

* Per Attendee $199

 

Analytical Method Validation and Transfer

webinar-speaker   Kelly Thomas

webinar-time   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.

17 / Oct / 2025 - Friday

* Per Attendee $199

 

Good Documentation Practice (GDP) and FDA Validation Compliance for Regulated Computer Systems and Data

webinar-speaker   Carolyn Troiano

webinar-time   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.

20 / Oct / 2025 - Monday

* Per Attendee $199

 

OSHA Inspection Readiness: What to Expect and How to Prepare

webinar-speaker   Joe Keenan

webinar-time   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.

20 / Oct / 2025 - Monday

* Per Attendee $189

 

FDA's New Software Validation Requirements

webinar-speaker   John E Lincoln

webinar-time   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.

22 / Oct / 2025 - Wednesday

* Per Attendee $199

 

Mapping and Review of Pharmaceutical Warehousing and Distribution Workflows

webinar-speaker   Michael Esposito

webinar-time   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.

22 / Oct / 2025 - Wednesday

* Per Attendee $199

 

Sanctions: We have an OFAC violation: What to do!

webinar-speaker   Justin Muscolino

webinar-time   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.

30 / Oct / 2025 - Thursday

* Per Attendee $189

 

Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR

webinar-speaker   David Nettleton

webinar-time   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).

6 / Nov / 2025 - Thursday

* Per Attendee $229

 

EPA Tier II Reporting

webinar-speaker   Joe Keenan

webinar-time   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.

Recording Available

* Per Attendee $229

 

21 CFR Part 11, FDA’s Guidance for Electronic Records and Electronic Signatures

webinar-speaker   Carolyn Troiano

webinar-time   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.

Recording Available

* Per Attendee $229

 

Conducting an ACH Risk Assessment and Developing an Effective Risk Management Program

webinar-speaker   Donna K Olheiser

webinar-time   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.

Recording Available

* Per Attendee $249

 

Ethylene Oxide and Gamma Radiation Sterilization Validations

webinar-speaker   John E Lincoln

webinar-time   90 Mins

Product Id: 707018

Gamma and EO Sterilization verification and validations under the U.S. FDA and EU's EMA / MDR requirements

Recording Available

* Per Attendee $249

 

Fair Lending in 2025: new regulations, examinations and enforcement

webinar-speaker   Justin Muscolino

webinar-time   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.

Recording Available

* Per Attendee $249

 

Stability Studies and Estimating Shelf Life

webinar-speaker   Steven Wachs

webinar-time   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.

Recording Available

* Per Attendee $249

 

Conducting Your 2025 Annual ACH Rules Compliance Audit - a Step-by-Step Guide

webinar-speaker   Donna K Olheiser

webinar-time   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).

Recording Available

* Per Attendee $249

 

Effective Systems for Change Control in the Pharmaceutical Industry

webinar-speaker   David L Chesney

webinar-time   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.

Recording Available

* Per Attendee $249

 

US Market Access & Reimbursement : Medical Devices

webinar-speaker   Robert J Russell

webinar-time   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

Recording Available

* Per Attendee $219

 

Analytical Method Development, and Method Transfer

webinar-speaker   John E Lincoln

webinar-time   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.

Recording Available

* Per Attendee $219

 

Total Organic Carbon Analysis for Cleaning Validation in Pharmaceutical Manufacturing

webinar-speaker   Joy McElroy

webinar-time   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.

Recording Available

* Per Attendee $199

 

 

 

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