Compliance Training Webinars for Regulated Industries

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.

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.

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.

This Sterilization training will provide valuable information to companies that design products for terminal sterilization with ethylene oxide.

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.

This webinar will focus on the current trends in FDA Inspections and guidelines and how this information can be utilized to provide a foundation for compliance with the latest quality and regulatory requirements. Attendees will learn how to proactively prepare for an inspection.

Onboarding new employees in a pharmaceutical company, which is required by law to follow the regulations governing current Good Manufacturing Practices (cGMP), creates additional complexities besides the Human Resources element. As government regulatory agencies have expectations regarding the process of qualifying employees to perform their job duties, it is essential to become familiar with these expectations and the implications that they have for the company’s training plan. In addition, companies have been penalized for failure to follow established regulations, which can create issues that can impede production, damage a company’s reputation, or ultimately lead to recalling or discontinuing product. Still, the process is not straightforward, and questions inevitably arise regarding the application of the regulations. This course will address the issues that accompany onboarding new or transferred employees and enable you to navigate them successfully.

This webinar provides the logic and processes for determining samples sizes for common tests used in verification or validation of processes. The focus of this webinar is on providing the information needed for attendees to know the appropriate measures and formulas to use for the determining sample size and providing justification for the planned sample sizes.

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.

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.

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.

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.

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.

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.

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.

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.

This FDA compliance training will cover in detail the new requirements for trial master files including documents related to clinical trials that are required to be prepared, collected and maintained as part of the TMF.

Both the U.S. FDA and EU's MDR expect documented risk-based IQ, OQ, an PQs of medical packaging lines under U.S. FDA cGMP, EU MRD, ICH Q7 and Q9 and ISO 14971

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.

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.