Training - Events

This highly interactive two-day course uses real life examples and explores proven techniques for reducing costs, usually by two-thirds, associated with implementing, and maintaining computer systems in regulated environments. It details the requirements for Part 11 and Annex 11: SOPs, software product features, infrastructure qualification, and validation. The instructor addresses the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation. Understand the specific requirements associated with local and SaaS/cloud hosting solutions. Nearly every computerized system used in laboratory, clinical, manufacturing settings and in the quality process has to be validated. Parti…

In this two day workshop conference you will learn the requirements and expectations of major health care regulators that are applicable to "virtual" companies. You will learn how to diagnose your company's needs based on which GMP and GCP-governed operations you retain and which you outsource; what the current expectations and best industry practices are for selecting, qualifying and monitoring your contractors to ensure they are meeting your requirements; and how to build a quality system framework that is not excessive for your current needs, but has the structure and integration to "grow with you" as the scope your operations change in the coming months and years. Learning Objectives: Participants in this seminar will: Understand the GMP and GCP requirements all virtual companies must…

Use coupon COMPLIANCE15 to get 15% discount on this virtual seminar This seminar bridges that gap. Designed specifically for non-statisticians, it provides a clear, practical introduction to biostatistics without overwhelming you with mathematics. You’ll learn the “why” behind the numbers, gain tools to spot meaningful findings, and avoid being misled by misused statistics. By the end of the program, you’ll be able to read statistical reports with confidence, communicate findings to colleagues and stakeholders, and make better data-driven decisions that can shape the future of clinical and biotech innovation. Why Should You Attend: In the world of clinical research and biotechnology, numbers carry weight. A single statistical finding can influence whether a project moves forward, a regulat…

Use coupon COMPLIANCE15 to get 15% discount on this virtual seminar Sterile products may be broadly classified into two main categories based on their production mode -- those that are terminally sterilized following the filling and sealing of the container and those that are aseptically sterilized, that is, filter sterilized as a bulk product, filled, and then sealed. Aseptic Processing play a critical role with large molecules that cannot be terminally sterilized. The verification of the process to produce sterile product is evaluated through the demonstration of various media fill process simulations that will vary in both numbers and size of the containers as well as the volumes filled over a defined period.  Aseptic Processing involves risk assessment on an on-going basis because…