Medical comms - Events
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…
This program combines general considerations for Good Manufacturing Practice (GMP) compliance management with the principles of phase-appropriate GMP considerations, with an emphasis on needs of virtual companies. (“Virtual companies” are those who outsource GMP operations to Contract Manufacturing Organizations (CMOs) and Contract Analytical Laboratories.) Virtual companies typically do not conduct “hands on” manufacturing, but do perform tasks which are governed by GMP, for example, dispositioning final product, managing the supply chain, investigating complaints, and providing training to staff in GMP compliance concepts. Such companies often struggle to decide how to structure their quality management system, which procedures they need or do not need, and how to best manage vendor rela…