This webinar will help you to establish a Quality Management System (QMS) for Medical Device Companies. A well-structured QMS meets the requirements of the Quality System Regulations and is both effective and efficient. The regulations require that manufacturers “establish and maintain a quality system that is appropriate for the specific medical device(s) designed and manufactured”. In order to “establish” a suitable and effective QMS, medical device companies must be able to “say what they do, do what they say, and prove it”!
In this webinar, learn how build SOPs and work instructions. Also learn how regulatory compliance, compliance documentation, and technical operations training and improved performance, standardization and regulatory compliance are uniquely associated.
This training program will focus on defining and explaining numerous concepts and terminologies in a simple language as related to the safety, efficacy and quality assessment of pharmaceutical products for human use. It will also describe the necessity of understanding the basic physiological concepts pertinent to drug actions, product developments and evaluations.
This healthcare compliance webinar will focus on the risk of MRSA colonization to patients and others. Attendees will learn the current practice of nasal screening and isolation for MRSA colonized patients will be described as well as universal decolonization as an alternative will also be discussed.
This 2-hour webinar will cover the basics of design controls for medical devices. Design Controls are an integrated set of management practices that are customer focused and ensure quality and consistency. An effective and efficient design control process results in a predictable product development process with improved quality and compliance result. This webinar can help you create a design control process that is a competitive strength for your company.
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process. Not only do they fail to achieve necessary improvements, they waste precious time and resources. In these companies, CAPA is a 4 letter word. This webinar will help you avoid identify the symptoms of this common problem. Learn how to avoid those struggles and establish an efficient and effective CAPA process leading to improved quality and compliance for your company. You’ll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this webinar is for you.
This webinar addresses the Computer Software Assurance guidance related to 21 CFR Part 11, and the European equivalent Annex 11 for local, and SaaS/Cloud hosted applications. It details the evolution of industry practices that increase productivity and ensure compliance. Learn the latest validation models and fill-in-the-blank templates.
This training program will provide attendees with a better understanding of current Quality System Regulations (QSR) require companies to maintain qualified equipment, utilities and facilities in a state of control. When changes are made to these items, the change must be documented, explained as to what will be done and the items that may be impacted. This webinar will also highlight what is expected, what to include in procedures and address the challenges faced by industry in trying to establish an effective and manageable program.
