Medical Device 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).

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.

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

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.

In this webinar, learn how to implement the changes required by the new regulation EU MDR 745/2017 in your current quality management system in a simple and quick way. The information in this course is vital to your passing the Quality Management Audit by your certification company or notified body.

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 will give you a clear structured overview and introduction, into the cybersecurity risk management in relation to the cybersecurity regulation in EU and US and its requirements in the EU and US.

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.

CGMP companies must develop / implement formal software V&V for medical product under IEC 62304 and a key US FDA Guidance Document.

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.

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.

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.

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.