This Medical device training will be discussing the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products.
In this webinar, learn how to write technical documents in a highly specialized, highly regulated field like the pharmaceutical industry. It will teach you the techniques that that are easy to understand and help in creating high quality documents with the least amount of problems.
Attend this webinar to learn about the Brazilian pharmacovigilance regulation, risk management, the Health Brazilian Constitution Rights. Learn about labeling, safety reports, harmonization process, benefit-risk legal concept, reciprocity, and more.
This course will review regulatory guidance governing Suppliers and the elements of a robust supplier management program including, initial qualification, supplier performance monitoring, and scorecards, supplier audit options, and quality agreement requirements. It will discuss how to utilize risk-based quality tools to determine supplier classification with a risk assessment example. Recent FDA audit findings will also be reviewed.
Non-conforming material happens. And medical device companies must deal it. This 90-minute webinar will help you to make sense of confusing regulations and effectively deal with non-conforming material. You’ll learn how to identify, segregate, control, and disposition non-conforming material. You’ll learn about when and how to conduct failure investigations and requirements for correction and corrective action.
Learn the basic overview of the original medical device Quality Management System -- The US FDA’s CGMP, Quality System Regulation (QSR) under 21 CFR 820. Implementation, training requirements and content, and annual internal audit / inspection expectations. The FDA’s four key areas of compliance under QSIT.
This webinar will help understand DRG system used as the structure for reimbursement under Medicare/Medicaid programs including review of DRG relative weights, case mix index, length of stay, medical record coding, managed care contracting, bundled payments and strategies to control cost and length of stay in bundled payment environment.
This webinar will familiarize participants with USP Chapter <1029> on good documentation guidelines. This session will wrap up the general concept and will provide information as to what needs to be documented in certain records.
This 1-hr virtual seminar will teach how to integrate cell-based assays into your GMP processes to ensure success of GMP-mandated stability studies. You will learn critical information about GMP requirements, how to validate bioanalytical methods, how to use cell based assays for clinical work and commercial work.
If you develop or manufacture a product regulated by FDA you will need to interact with FDA employees. It is important to interact with the FDA employee in the most productive manner. But there is a variable you must deal with that will determine how productive your interaction is. The variable is the FDA employee. That is the purpose of this webinar.
This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOP’s to reduce the likelihood of human errors.
The expectations for quality remain the same for batches produced continually vs. bath-to-batch. However, the quality unit must transition to a very different control strategy to ensure product quality. This webinar will discuss quality and compliance considerations for continuous manufacturing as per the FDA draft Guidance for Industry (Quality Considerations for Continuous Manufacturing, February 2019) and with input from other FDA Guidances and ICH documents. The content is intended for small molecule solid oral drug products, but concepts can be applied to other products.
Attend this training to learn how to implement a Human Error Reduction Program at your site. It includes practical tools and explains how to measure effectiveness to continuously improve human reliability at your site.
Attend this webinar to learn the CMS new regulation "the two midnight rule" and what are the medical and financial outcomes of the rule and how to apply the rule correctly to remain CMS compliant and the Controversial of the rule.