Life Sciences Regulatory Compliance Training - Live Webinars, Recordings & CDs

This webinar will explain how to implement an effective and FDA compliant GMP training program. It will discuss regulatory requirements and expectations for a well-trained workforce.

This webinar will make a distinction between nomenclatures (serious adverse events, adverse events, anticipated events, unanticipated events and unanticipated problems) and discuss the reporting requirements to the FDA and Office for Human Research Protections (OHRP).

This training program will offer an interpretation of the latest ruling of Reach SVHC. It will also discuss the RoHS directive – the four substances added to the restriction list in Annex II.

This training program will help attendees understand the requirements of the FDA UDI regulation and the labeling requirements of the UDI regulation. The program will also focus on data elements that make up a UDI compliant barcode and GUDID data attributes and submission process.

This training program will dispel mistaken paradigms regarding the risk based approach to introduction of rapid microbial detection systems for water systems. Attendees will understand how to validate and transfer LIF method and how to validate LIF instrument against currently used methods.

This training program will explore the ABCs of facilities enhancement – compliance-driven actions that get results. It will also discuss devising and implementing a bullet-proof plan to reach goals, set expectations, and lower costs.

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 3 hour virtual seminar will help you gain a comprehensive understanding of ICH GMPs and the nuances and differences between requirements in the US, EU and Japan. It will prepare you for regulatory inspections in these countries.

This 90-minute webinar will help you gain a comprehensive understanding of ICH GMPs and the nuances and differences between requirements in the US, EU and Japan. It will prepare you for regulatory inspections in these countries.

This training program will help attendees understand the sources of mycoplasma contamination and how to minimize the occurrence of contamination. The regulatory standards for testing will be described as well as the methods of mycoplasma detection and the resources for testing. At the conclusion of this webinar, attendees will have knowledge of the importance of mycoplasma contamination testing and how to successfully perform the tests in their company’s setting.

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 provide professionals with essential elements of CAPA investigations to assure compliance with regulatory requirements. The corrective and preventive action (CAPA) program is an essential element of a compliant quality management system, as required by international regulations and voluntary standards. Investigations are the backbone of the CAPA program.

The objective of this virtual training seminar is to assist attendees in understanding and being able to apply FDA regulations for OTC drugs and to label and market them successfully in the U.S. while avoiding regulatory problems. The program will also explore other verticals such as: OTC drug monographs and their importance to product marketing, a summary of OTC drug GMP regulations, FDA rules for adverse event reporting of OTC drugs, avoiding FDA Warning Letters, and more.

This training program will focus on understanding and accepting our respective responsibilities to help ensure that our food supply is safe by pursuing a food safety culture locally, nationally and globally.

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.