How do companies interpret the regulations and expectations for their cleaning validation programs? What happens if they do not consider the toxicological limits for their products from regulatory and science based perspectives? What types of products does it apply to? What is an ADE and PDE? How and where does a company start? Answers to these questions and much more will be discussed in this interactive course.
This session will be valuable to clinical trials and associated/related personnel responsible for archiving, storing, and organizing documents in a clinical setting.
Managing the construction of a clear, concise dossier can be a daunting task, but it doesn’t have to be. A simple understanding of best practices surrounding the creation and presentation of the CMC section will make for a successful submission…as long as your data is accurate and compelling!
With the recent ICH E6 changes to include Quality Management in the conduct of clinical trials, it is important for companies to understand how to implement Quality Management – which includes Risk-Based Monitoring (RBM) – into their studies. The purpose of this session is to help you develop and implement a change management strategy that eases the burden of transition.
The recent changes in National Institutes of Health/Health and Human Services (NIH HHS) requirements (Final Rule) for registration of clinical trials and submission of results information will apply to all clinical trials of medicinal products (including Biologics) and device products. This webinar breaks down the final rule into a digestible, convenient format that will put you and your studies on the road to compliance.
This course will focus on the current top five FDA regulatory trends, warning letters and enforcement actions related to Computer Systems Validation (CSV).
The recent changes in the requirements for initiating clinical trials within the European Union apply to all clinical trials of medicinal products (including Biologics). This presentation will provide you with an understanding of key updates, major differences, and common trouble spots.
Expansions and renovations to existing biological facilities – and construction of new facilities – provide a unique opportunity to rethink basic design strategies and use new technologies to build a better facility that will reduce costs and improve compliance. This webinar will discuss how process and regulations are changing the modern biotechnology facility and process design paradigm.
Through this course you will be able to assess your existing quality system processes and understand the changes that will need to be implemented in your organization to comply with the revised ISO 13485 standard and to meet expectations from notified bodies.
While the idea of fewer inspections is a positive for industry – meaning less time will be spent with multiple regulatory agency inspections – each inspection now carries even more weight as it will be accepted by multiple agencies. Understanding both US Food & Drug Administration (FDA) and European Medicines Agency (EMA) GMP regulations is now more important than ever.
This course will be of benefit to anyone in the life sciences who is interested in 3-D printing as a method for developing a therapeutic product (e.g., medical device, drug delivery system, etc.), including those already using 3-D printing but want a better understanding of FDA’s position on the subject.
The purpose of this training is to present techniques and strategies for auditing computer systems validation documentation for compliance to applicable global regulations, plus internal policies and SOPs. Current issues including cloud systems and data integrity will be discussed.
In this training, you’ll learn the five common areas where device trials tend to fail, plus review actionable steps to help you anticipate potential pitfalls and resolve them before they occur.
In order to assure your firm’s data integrity, staff must be kept up-to-date on the handling of laboratory data/results – especially failing or out of specification (OOS) data. This webinar will cover the current expectations for handling OOS investigations – including the process, roles/responsibilities, and expected outcomes.
We use cookies to ensure that we give you the best experience on our website. If you continue to use this site we will assume that you are happy with it.Ok
