Implementing a Quality Management System (QMS) involves a structured process to ensure consistent quality across an organization's operations. It typically starts with understanding the organization's context, defining policies and objectives, mapping key processes, and then implementing, monitoring, and continuously improving the system. The implementation process can vary based on the organization's size and complexity, but generally takes 3-18 months depending on an organization’s size.
This webinar discusses methods for estimating process capability for both normal and non-normal data. Methods include estimating the proportion of defective products that may be produced as well as the calculation and use of common process capability indices (e.g. Cpk and Ppk). Process Capability assessments are discussed in the overall context of quality improvement/management.
Mapping and evaluating all the steps in a current pharmaceutical ingredient bulk manufacturing workflow can lead to valuable process improvements. In this webinar, we discuss how this review can be accomplished and the possible benefits that can result.
The 80 problem solving process developed by the Department of Defense and driven by Ford Motor Company is a worldwide method used to improve quality address customer complaints and issues quickly and efficiently. The process helps develop rapid response to customer issues and complaints and strengthens business relationship with those customers and regulatory bodies. The process helps improve quality and supports and promotes prevention rather than simply the detection of problems.
What are the U.S. FDA's recently expanded, less traditional / modified pathways for novel technologies or safer products to receive clearand or approval.
Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements. Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction, this body of information may be stored in a trial master file (TMF). All of the data and documents supporting the planning, conduct and evaluation of a clinical trial must be of the highest integrity, which must be maintained through their entire life cycle. Computer System Validation will be discussed as a key methodology for meeting all of these requirements and assuring data/document integrity.
A pre-approval inspection (PAI) is performed to provide the Food and Drug Administration (FDA) assurances that a manufacturing site named in a drug application is capable of consistently manufacturing a safe drug product, and that the submitted data is accurate and complete against what was filed in their application. This training will provide guidance on when the FDA performs pre-approval inspections. It will describe how to prepare for a PAI, and the outcomes of pre-approval inspections.
This FMEA (Failure mode and effects analysis) training will cover the Joint Commission requirements for conducting a proactive risk assessment using the FMEA methodology.
This Failure Modes and Effects Analysis (FMEA) Webinar will give an overview and elements of an FMEA. The analysis of data outputs will also be discussed.
PSURs are pharmacovigilance and device adverse events documents intended to provide an evaluation of the risk-benefit balance of a medicinal product at defined time points after its authorization in the EU. The purpose is to harmonize and strengthen benefit-risk review of medical products across the European Economic Area.
Attend this webinar to understand, what are the changes to the previous medical device regulation and how to implement the changes in your current quality management system in a simple and quick way. These needs smart ideas to reach the right level to pass the quality management audit by your certification company or notified body.
Attend this webinar if you are faced with the task of having to register a product worldwide and need to think about the most sensible and efficient way to do so. The correct order of the countries and the provision of the documents and what the differences are between the various technical dossiers of the countries are often decisive here.
Attend this webinar to understand, what are the requirements of article 32 EU MDR 2017/745 for implantable devices and for class III devices, other than custom-made or investigational devices, the manufacturer shall draw up a summary of safety and clinical performance (SSCP). Your implementation needs smart ideas to reach the right level to pass the quality management audit and technical file audit by your notified body or authority inspection.
This course offers practical approaches and tools to address human performance issues in GMP related environments by using a particular methodology to correct, prevent and avoid reoccurrence of these matters.
This webinar will help you identify factors that cause delays as patients progress through their stay and how to correct these barriers to care. Learn the most streamlined ways in which to integrate avoidable delay management into your day and with all the members of the interdisciplinary care team. Finally, it will review some examples of report cars that can be used to understand the data you have collected.
This instructor-led live webinar will discuss the established approach of Pharmaceutical Quality Management as it relates to the relationship between risk management and the pharmaceutical regulations that govern the business.
The 21 CFR Part 111 dietary supplement regulations require six categories of specifications before established before manufacturing product or releasing a batch into distribution. This course will review the six categories and their regulatory requirements while translating those requirements into a workable document.
