Biotech Regulatory Compliance Training - Live Webinars, Recordings & CDs

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.

This training program will examine the many facets of disposable bioprocessing systems that incorporate a wide scope of polymeric single-use products. Single-use disposable technologies, from upstream to downstream processes, will be reviewed as related to the use of polymeric devices. Specific attention will be given to the related applications used in the production of biopharmaceuticals and pharmaceuticals.

This training program will address the daunting task of conveying complex technical data clearly, concisely, and purposefully to technical and non-expert audiences alike. Writing examples from diverse technical fields makes this webinar highly relevant. The program will build a foundation for learning by identifying the qualities of effective writing and the roadblocks to overcoming them.

This training program will elucidate the similarities and differences between the FDA and Health Canada promulgations of regulations impact preparation. The course will also offer a review of the background and history behind the FDA and Health Canada.

This training program will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA. This webinar will focus on how to avoid the pitfalls that may occur during FDA inspections and help eliminate 483 observations. Attendees will learn how to identify and avoid potential pitfalls during deviation investigations.

This training program will assist 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. It will help attendees in determining how well your company is positioned to defend your FDA submission.

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 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 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 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.

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.

The webinar will discuss the current available regulatory pathways to develop FDA-regulated 3D printed products and also predictions on what to expect in the near future. 3D printing in personalized treatments will be discussed and attendees will be provided practical tips for pursuing approval with the FDA.

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 webinar will cover the regulatory perspective in testing raw materials for microorganisms and how you can manage the risk of raw materials being the major source of microbial contamination in your medical product manufacturing process.

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.