
Designing an Effective Cleaning Validation for Reusable Medical Devices in Today's Regulatory Environment
Gerry O Dell
90 Min
Product Id: 701929
This training will review the best practices establishing and conducting a cleaning validation for reusable medical devices. It will also address the requirements of ANSI/AAMI ST 98.

Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries
Joy McElroy
120 Min
Product Id: 704531
This technical writing training program will offer attendees an understanding of how the reporting process supports products in research, development, and in the marketplace. This virtual session will highlight the mandates for documentation set forth by the regulators, such as the FDA, the ISO, and other governing bodies. The program will train attendees on effectively reviewing and revising documents and assessing your audience, in effect producing effective written correspondence.

Conducting Effective Quality Audits: Beyond Audit Checklists
Michael Ferrante
60 Min
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.

FDA Bioresearch Monitoring Inspection Program 2024
David L Chesney
90 Min
Product Id: 706994
This webinar presents a survey of the FDA’s Bioresearch Monitoring Program, a series of FDA inspection programs covering regulatory inspections by the FDA of clinical trial sites, sponsors and Clinical Research Organizations, nonclinical testing laboratories, Institutional Review Boards (IRBs) and post marketing adverse event reporting requirements.

UK RoHS and REACH: Post Brexit Obligations and Changes in 2024
Kelly Eisenhardt
60 Min
Product Id: 706679
This 1-hour webinar will provide high-level overview of the UK RoHS and REACH obligations effective January 1, 2024 due to Brexit. Key developments and dates will be discussed with an emphasis on the new regulations and systems implemented by the UK.

Toxic Substance Control Act (TSCA) Awareness Training 101
Joe Keenan
90 Min
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.

Precision Tools for Error Reduction: Strategies and Implementation Techniques
Ginette M Collazo
90 Min
Product Id: 704364
This training program will analyze the factors and causes behind human errors. It will define the process to manage human error deviations and participants will learn about human error measurement. The program will also discuss tools for measurement and Key Performance Indicators (KPIs).

How to Prepare an Effective Audit Manual for an Internal Audit Department
Marna Steuart
75 Min
Product Id: 703684
This webinar will instruct attendees on how to develop an internal audit manual and offer start to finish instructions and templates on how to perform different types of audits given the project description. Audit fieldwork, audit reporting and follow-up, work-paper filing, and project closure are some of the other areas the webinar will cover.

Nacha Updates in the ACH Network (Operations Bulletins-RFC and RFI Details)
Donna K Olheiser
90 min
Product Id: 707007
As payments continue to evolve, so does the ACH Network. In an effort to continually update the Nacha Operating Rules, Nacha had put out a RFC (Request for Comment) on adding a fourth window of opportunity for SDA (Same Day ACH) payments to allow more functionality with Same Day payments in all time zones.

Writing Effective SOPs and Training Curricula
Michael Esposito
90 Min
Product Id: 705614
Standard Operating Procedures (SOPs) are a vital component of ensuring compliance with regulatory agency requirements for pharmaceutical manufacturing.

Elements of an Effective Change Control System
Michael Ferrante
60 Min
Product Id: 703345
This webinar will focus on the regulatory and design requirements for an effective change control system in the pharmaceutical industry. Attendees will learn the role and importance of change control system in implementing an effective quality system.

Understanding Tokenization and its Supporting Technologies - A Guide to Converting Real-World Assets into Digital Tokens on Blockchain
Stanley Epstein
90 Min
Product Id: 707004
Understanding Tokenization and its Supporting Technologies - A Guide to Converting Real-World Assets into Digital Tokens on Blockchain Web3 tokenization is a revolutionary concept that converts real-world assets or rights into digital tokens on a blockchain, allowing for secure and decentralized ownership, access, and value transfer. Unlike simple digital currencies, Web3 tokens can represent physical assets, intellectual property, or utility and governance rights within decentralized applications (dApps). This enables fractional ownership of assets, like real estate, and enhances investment opportunities without traditional intermediaries. As a key driver of the decentralized economy, Web3 tokenization is reshaping asset management and participation in digital ecosystems.

Structuring and Conducting Risk-Based Internal cGMP Compliance Audits
John E Lincoln
90 Min
Product Id: 701432
This training will evaluate the chief areas of an FDA cGMP compliance audit and help you understand the actual and anticipated changes in emphasis based on this new regulatory climate. It will prepare you and your company for tougher US FDA cGMP compliance audits.
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.

Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements
Roger Cowan
60 Min
Product Id: 703727
It is important that the sterile filtration process is fully understood and properly validated for your particular application. The process requirements and validation needs differ based on the filtration requirement. This webinar will offer attendees a comprehensive understanding of the same while emphasizing the different types of sterilizing filtration available and their application to your particular system. For instance, the application of sterile filtration to use-point compressed air will be discussed in detail.

China Regulatory Compliance for Life Sciences
Robert J Russell
90 Min
Product Id: 702037
China’s Life Sciences Compliance webinar will discuss the regulatory structure and requirements for compliance against China’s NMPA regulations for Pharmaceuticals, Medical Devices, Biologics and Combination Products.

You have a BI Positive or Product Sterility Positive - Now What?
Gerry O Dell
75 Min
Product Id: 703288
This webinar explains what actions should be taken following an unexpected positive result in a sterility test on a biological indicator (BI) during performance qualification or routine testing. It also addresses the actions to take when a test of sterility demonstrates unexpected growth during validation or routine dose audits. The various items that should be investigated to determine the root cause and the follow up to the investigation will be covered.

Using a Learning Management System (LMS) to Develop Pharma Training Curricula
Michael Esposito
90 Min
Product Id: 707006
Learn how to use Learning Management Systems (LMS) to create effective pharma training curricula and ensure GMP compliance. This webinar delves into the unique challenges of creating intuitive job position curricula, overcoming LMS limitations, and meeting FDA requirements. Discover how to define true pharma curricula, collect job function details, manage complex training needs, and demonstrate compliance during audits. Ideal for professionals looking to optimize training in pharmaceutical environments.

Quality Oversight of Manufacturing Documentation
John E Lincoln
90 Min
Product Id: 707005
This webinar is focused on the Quality Management System' oversight of manufacturing and its documentation. What is required of a compliant system according to ISO 9001, 21 CFR 820 / ISO 13485, and 21 CFR 210 and 211 ..

Latest Changes to RoHS and REACH for 2025
Kelly Eisenhardt
60 Min
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 2024. We will draw out key developments and key dates (if applicable) with particular emphasis on requirements for US firms.