Compliance Training Webinars for Regulated Industries

This training program will focus on FDA software guidance. It will elaborate on applying current provisions that NIST (National Institute of Science and Technology) has put forth in recent reports that FDA will integrate into its regulatory oversight as well.

This integrated risk management training for medical devices will discuss how to incorporate risk management as per ISO 14971 guidelines in all phases of medical device development. It will highlight the documentation needed to support the decisions made as part of the risk management process.

This training program will discuss investigator oversight and responsibilities, records management including source data, trial data handling and procedures, quality and risk management, vendor oversight and subcontracting, risk-based monitoring and last but not least root cause analyses in case of non-compliances.

This training program will analyze the general considerations for cGMP compliance and review the cGMP requirements in 21 CFR 4.4(b). The program will also discuss applications of cGMP requirements for specific types of combination products.

The webinar will discuss clinical evaluation, including the recommendations from MEDDEV 2.7-1 Clinical Evaluation: A Guide for Manufacturers and Notified Bodies. The training program will also cover MEDDEV 2.12-2 Guidelines on Post Market Clinical Follow-Up. Risk management, following EN ISO 14971: 2012, requires a risk management plan that includes activities related to collection and review of relevant production and post-production information. In this program, attendees will look at some approaches to write a post-production collection and review plan.

This training program will explore why human factors has become a vital part of the FDA’s medical device pre-market approval/clearance process. The FDA Center for Devices and Radiological Health (CDRH) recently issued two guidance documents on human factors that are key elements in determining pre-market submission strategies for manufacturers. In this webinar, attendees will learn how to provide clear and complete human factors submissions meeting the intent of these guidance.

This training program will explain how to manage a design program that will meet FDA requirements and minimize chances of your medical device being recalled. The program will also help in getting projects completed on time and within budget.

This training program will offer participants an understanding of the concept of E&L (Extractables and Leachables) studies and about developing an E&L study in a reasonable and pragmatic way - based on regulatory requirements, guidelines and recommendations.

This training program will discuss fundamentals of infection and the use of materials/drugs to fight infection, FDA regulatory approvals for drugs and materials used to fight infection, and future thoughts on approaches to fight infection.

This training program will assist those responsible for planning, executing or managing the integration of a business system with any laboratory system governed by FDA regulations. On completing the program, attendees will have an understanding of laboratory system computer validation planning, execution and management concepts, and how they apply to any integrated business system.

This training program will help attendees understand what adverse events, serious adverse events and unanticipated problems are, and why reporting them is important to a study hypothesis and is key to keeping subjects safe while on a clinical trial. They will also learn the responsibilities of the sponsor, site/clinical investigator and regulatory agency in reporting adverse events.

This training program is intended for anyone directly or indirectly responsible for the creation, content or validation of SDTMs, ADaMs, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. Professionals in the pharmaceutical, biotechnology and medical device industries who want to be 21CFR Part 11 or Good Clinical Practices (GCP) compliant in relation to regulatory submission environment will benefit from this course.

This training program will focus on understanding the drivers and benefit of using worksheets not only as a prompt for recording details but also in reducing efforts of the analysts and auditors in a GLP/GCP bioanalytical lab.

This training program will discuss stem cell sources and how to control stem cell differentiation, technologies (FDA and non-FDA) that exist in stem cell technologies, and the future directions and opportunities that exist for stem cell technologies.

This training course will provide a detailed overview of the regulatory requirements, local challenges and important cultural aspects of working with the lifecycle of life science products (pharmaceuticals, medical devices, biologics and combination products) as an importer or producer in Russia. It will offer a deeper understanding of cultural norms, and will discuss best practices for establishing relationships and protecting your intellectual property to be integrated into your company’s training and corporate business strategies.

This training program will explore why planning and implementing an information management solution can be a daunting task. Composing policies and procedures is a good start, followed by testing in small groups. But a lot of people are resistant to changing their work practices, especially if they have been working for an organization for a long time. The worst thing that can happen is that staff appears to be compliant with the new plan, but has found a way to continue their prior practices under the radar. The solution to this problem is a comprehensive initial and continuing educational plan.

This training program will discuss key terms and responsibilities related to FDA inspections and the purpose of the BIMO inspection program. It will also review the general purpose and overall process of an FDA inspection and enhance your inspection preparation strategies.

This training program will provide a review of the current testing requirements and discuss what happened to the old 87/91 LAL Guidance for Industry proposed guidance. The program will also discuss how to transition from one bacterial endotoxin test to another—understanding the RPT (Rabbit Pyrogen Test). Participants will also gain a clearer perspective of the Monocyte Activation Test (MAT).

This training program will provide attendees with the ultimate set of tools in order to help their firms properly create User Requirement Specifications (URS) for Computer Systems Validation (CSV) with emphasis on current industry trends in this particular area as well as current Food and Drug Administration (FDA) regulatory trends and enforcement activity.

This training program will illustrate the underlying idea that makes ANOVA work. It will also offer an understanding of the data collection issues you should plan and how to get access to ANOVA in Excel.