Webinar On 21 CFR Part 820 – Quality System Regulation – Applying Principles...
All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records....
View ArticleWebinar On Current Good Manufacturing Practices (cGMP) for Medical Devices...
The US Food and Drug Administration (FDA) states in warning letters “this inspection revealed that these devices are adulterated within the meaning of section 510(h) of the FD&C Act, in that the...
View ArticleVybrané kapitoly z gastroenterologie pro monitory klinického hodncení
Kolorektální karcinom (CRC) je nejčastější malignitou české populace. V léčbě CRC se v závislosti na stádiu uplatňují všechny modality onkologické léčby. Základem terapie lokalizovaných stádií je...
View ArticleWebinar On Line Clearance – Compliance Implications, Enforcement, and Best...
This webinar will present industry best practices for the documentation, execution, and accountability of line clearance. Line clearance documentation requirements are particularly important to...
View ArticleWebinar On OSHA and the Medical Practice
New updates under OSHA are in place. What are your risk factors? Do you have an up to date exposure control plan? Understand the risks of blood borne pathogens (BBP)? How to conduct a self-assessment...
View ArticleWebinar On Quality Control for Microbiological Media and Reagents
Description : Many laboratories are unsure about which QC practices are needed to assess media performance to meet not only their requirements, but also the requirements of ISO/IEC 17025: 2005. This...
View ArticleWebinar On Developing a Quality Management System
ISO Quality Management standards and the FDA Quality System requirements. Medical device companies are utilizing ISO standards to build their business management systems because of their benefits and...
View ArticleWebinar On 9 Required Elements of Design Control System
The FDA expects companies to perform meaningful, results driven Design Control activities as defined in 21 CFR 820.30, for both new and changed devices. The company is held fully responsible for...
View ArticleWebinar On Building a Successful Relationship with FDA – Key Steps
This webinar should be "required reading" for those who want to be a member of a drug project team and any of the sub-teams. The first step in the drug development approval process is knowing what...
View ArticleWebinar On Effective Purchasing & Supplier Controls in Accordance with 21...
If your organization is struggling with understanding the salient requirements associated with purchasing and supplier controls, this webinar is for you. This webinar will help your organizations...
View ArticleUnderstanding Biostatistics in the Medical Literature
This module covers key biostatistical concepts required to review and interpret findings published in the medical literature. Selected scientific publications are reviewed, discussed and criticised in...
View ArticleSpecialised Master in Biopharmaceutical Management
The aim of the ESCP Europe Specialised Master in Biopharmaceutical Management is to prepare future managers of pharmaceutical, medical consulting and biotechnology companies for immediate insertion...
View ArticleWebinar On Train-the-Trainer Toolbox: How to Prepare & Deliver Engaging &...
Does your organization utilize in-house trainers? Do these trainers lack the program development and delivery skills they need to be successful? In this program, Judi turns your employees into...
View ArticleWebinar On Preventing Medical Device Recalls
The secret to preventing medical device recalls is to implement and follow basic practices for specifications and design control, design for process reliability, production validation and design...
View ArticleWebinar On Here Today Gone Tomorrow: Tools for Managers & Human Resource...
Description : As a manager, one of your most important roles is helping your employees successfully navigate change. Change is usually both a positive and negative experience. At first, employees may...
View ArticleWebinar On Good Documentation Practices
The webinar will discuss basic/key requirements for writing SOPs, recording data, completing forms and other basic documentation requirements for the GMP compliant company. Furthermore, the current...
View ArticleWebinar on Design Verification, Validation and Testing for Medical Devices
Design Control is an integral part of any quality system in regulated industries. FDA Quality System regulation, Quality System Inspection Techniques (QSR and QSIT) and ISO 13485 have specific product...
View ArticleWebinar On Big Data and its Importance to Quality And Compliance
This session will encompass in-depth discussion around the topic of what big data is, how it impacts the industry, and how it can be used to accomplish goals for an organization. More specifically,...
View ArticleWebinar On U.S. FDA Project Management
This webinar is not a project management certification course. However, it is designed to provide the tools necessary to assist those designing a result or deliverable to achieve that end. It will...
View ArticleWebinar on Changes under the HIPAA Omnibus Rule – What’s New
Description : This lesson will be addressing the major changes from the September 23rd 2013 HIPAA Omnibus Rule and any other applicable updates at the time of the presentation. There are an enormous...
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