FDA Regulatory Compliance Training - Live Webinars, Recordings & CDs

The life science industries, including pharmaceutical, medical device, biotechnology, biological, and tobacco and tobacco-related products continue to embrace new technology to improve delivery of quality products in compliance with FDA. In addition, we’ve seen a trend toward making use of cloud services, Software-as-a-Service (SaaS) solutions, and other technical innovations such as use of Artificial Intelligence (AI), Machine Learning (ML) and Large Language Models (LLMs), such as ChatGPT that have more recently begun to be used more heavily in life science companies.

Statistical significance alone is no longer sufficient to support regulatory claims. Modern regulatory review requires careful interpretation of effect size, confidence intervals, robustness, and clinical relevance. This webinar provides a technically grounded, example-driven approach to interpreting p-values and statistical results in regulatory submissions.

Proper adherence and documentation of the FDA's Design Control requirements are key to any medical product project's success.

The US FDA/CDRH is proposing to harmonize the current Quality System Regulation (QSR) for medical devices (21 CFR 820) by converging its requirements with requirements used by many other regulatory authorities. ISO 13485, into a new device Quality Management System Regulation (QMSR).

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.

Learn how to effectively develop, prepare, and execute job aids in the pharmaceutical industry. This webinar covers the key characteristics of job aids, their purpose, use in training, and their role in qualifying individuals for independent tasks. Understand the importance of document hierarchies, skill checks, and how to train others to deliver job aid training.

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.

The US FDA, a has finally published their QMSR to replace the previous QSR. Implementation deadline is February 02, 2026. The quality Management System Regulation (QMSR) revises 21 CFR 820 to include ISO 13485:2016 (and ISO 9000m Clause 3) by reference. For FDA inspections, no QSIT 2.0 on the way. Instead, FDA inspections will transition to a process aligned with ISO 13485, described in the Medical Device Compliance Program. This is a shift from QSIT’s subsystem model to a process-focused inspection approach, a heavier emphasis on risk management, and a resultant hybrid compliance burden between a company's legacy QSR requirements and new ISO-based expectations of the QMSR.

Cybersecurity is the art of protecting networks, devices, and data from unauthorized access or criminal use. It is the practice of ensuring confidentiality, integrity, and availability of information.

The objective of this live, interactive webinar is to explore raw materials in a cGMP environment, their various regulatory requirements and how they may affect the timeline of meeting the release date of your Company’s products. Please plan to bring additional personnel to the webinar to obtain cross-Departmental training.

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.

The objective of this live, interactive training webinar is to explore the role of media fills in assuring that manufactured product will retain the sterility assurance level prescribed by GMPs. It will review the issues regarding preparing media and setting up the “filtration train”, environmental monitoring, interruptions that may occur during the operation of the Clean Room (planned and unplanned) and the cleaning of the room and its equipment. Equipment used to monitor the equipment and personnel will also be reviewed along with gowning issues that periodically arise. The webinar will also discuss media failures and how to “work through” them. Because of the sensitivity and importance of media fills, this live, interactive training webinar is a MUST for anyone in your organization that is involved in aseptic filling in general and media fills, in particular.

This training program will offer attendees an understanding of human error, its factors and causes. The program will also identify the regulatory and business importance of human error prevention and define the process to manage human error deviations.

This course will provide an overview of the requirements for aseptic and bulk manufacturing operations, including facility design, contamination controls and acceptable personnel behaviors.

The webinar will review the current testing requirements as defined in the new, revised FDA guidance on Endotoxin and Pyrogen testing. It will further help attendees understand the issues surrounding the Low Endotoxin Recovery (LER) and its regulatory outcome.

Not every parameter in the EO sterilization process in critical for the determination of the product’s sterility assurance level (SAL). This presentation will outline the various parameters and what actions should be taken when they are not compliant to the process specification. These actions can be as simple as a rationale for release to as complicated as the need for the qualification of a new sterilization process. How to decide the actions to take will be addressed along with the reasons behind the decisions so that an accurate and complete justification of your decision can be made for both management and regulatory agencies. The rationales for both conventional and parametric release will be addressed.

The regulation and control of new or substantially changed medical devices for sale in the US is based on the 510(k), PMA or DeNovo submission process; 510(k)s now can only be submitted to the FDA under the eSTAR (electronic Submission Template And Resource) Portal. Other submissions will be phased in using new guidance templates as they become available.

This webinar provides a basic understanding and fundamental principles of Current Good Manufacturing Practices and will fulfill the requirement of personnel involved in cGMP must have documented training of current Good Manufacturing Practices. This session will focus on the FDC Act and 21 CFR federal regulations as applied to cGMP.

This webinar provides details regarding the generation of acceptance sampling plans often used in process validation and production control to ensure quality of final products. By attending this webinar, participants will be able understand the key inputs and issues involved in determining acceptance sampling plans. Sampling plans for attribute data are the primary focus although variable acceptance sampling plans are presented as well.

The California Consumer Privacy Act (CCPA) was enacted into law on June 28, 2018 and became effective on January 1, 2020. CCPA provided a variety of consumer privacy rights and the obligations of business related to their storage and sale of personal information.

Voters in California voted to approve Proposition 24, a ballot measure, on November 3, 2020, which created the California Privacy Rights Act (CPRA). The purpose of CPRA was to modify and expand the requirements of the CCPA, thus amending the original act. CPRA is commonly referred to as “CCPA 2.0.”

CPRA ends the ban on providing the CCPA’s consumer privacy rights to a company’s employees. Under CPRA, all employers must respond to requests from employees to access or correct their personal data. Enforcement of CPRA will become effective in July 2023, enabling companies six months to ramp up their efforts to comply with it.

CPRA also extends new protections to consumers residing in California. Those organizations doing business with these consumers are subject, based on defined threshold of operation, to the compliance requirements.