
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.

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.

Guidelines for Performing a Corporate Wide Internal Audit Risk Assessment
Marna Steuart
75 Min
Product Id: 703775
Performing a corporate wide risk assessment is doable, and can provide internal audit and its organization a roadmap for the upcoming audit year. In this webinar, participants will learn how to maximize the time spent on the risk assessment process on an annual basis.

NEW Reclamation Process - Fed Gov't Payments
Donna K Olheiser
90 Min
Product Id: 706928
Processing ACH Reclamations from the Federal Government can be challenging! Chapter 5 of the Green Book has been updated making it mandatory for Financial Institutions to respond to all reclamations must be submitted through the Automated Reclamation Processing System (ARPS) located in Treasury’s Pay.gov web portal (except for responses by DFAS and any Treasury-approved exceptions). The Nacha Operating Rules still apply when processing these payments but the Green Book outlines exceptions when handling DNEs (Death Notification Entries) and Federal Government Reclamations. A side-by-side comparison of Commercial vs. Government Reclamations will be included to know what the difference is and how to handle each one.

Quality Agreements and Their Role as Part of a Quality System
Michael Ferrante
90 Min
Product Id: 706966
This webinar will focus on the Process for Quality Agreements and requirements that must be implemented to ensure compliance with the latest quality and regulatory requirements. Attendees will learn the reason for implementing a Quality Agreement system to assure adequate controls for Service Providers.

Storm Water Pollution Prevention Plans (SWPPP)
Joe Keenan
90 Min
Product Id: 705510
This webinar will discuss the basics of what is required in a Storm Water Pollution Prevention Plan (SWPPP), how to develop and implement and formalized SWPPP and address site-specific questions and scenarios.
Computer Software Assurance: Use industry standards to be efficient and compliant
David Nettleton
75 Min
Product Id: 707008
This webinar addresses the Computer Software Assurance guidance related to 21 CFR Part 11, and the European equivalent Annex 11 for local, and SaaS/Cloud hosted applications. It details the evolution of industry practices that increase productivity and ensure compliance. Learn the latest validation models and fill-in-the-blank templates.
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.

EPA Tier II Reporting
Joe Keenan
60 Min
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 for Performing a Vendor/Contract Audit: What Should be Considered and How to Plan, Perform and Report Results of a Vendor Audit
Marna Steuart
75 min
Product Id: 706219
Attend this webinar to learn about the different contract terms, different ways to determine the scope of the audit given contract terms and conditions, how to plan, perform and report results of a vendor audit.

CMO Supplier Quality Agreements - How to Comply with New FDA and EU Guidelines for Contract Drug Manufacturers
Roger Cowan
60 min
Product Id: 703476
This webinar will include a detailed discussion of Contract Manufacturing Organizations (CMO) Quality Agreement topics such as change control, documentation, facilities and equipment, lab controls, sub-contracting, etc. Attendees will learn how to comply with new FDA and EU guidelines for contract drug manufacturers.

Supply Chain and Product Compliance Using RoHS, REACH, and Conflict Minerals
Kelly Eisenhardt
60 Min
Product Id: 703871
This training program will offer an in-depth look at three important product regulations focused on materials compliance and ethical sourcing, along with the tools and policies needed to implement them.