Corrective and preventive action (CAPA) is a process of the quality management system that begins with the identification of a problem (or opportunity), goes through a series of steps including identification of the root causes and deployment and verification of a solution, and documentation and deployment of lessons learned. The deliverables include not only elimination of the problem at hand, or realization of the opportunity, but application of the best practices learned to related activities.
This webinar will benefit medical device companies planning to have a CE mark under the European Union Directive 93/42/EEC. We will discuss what is new in ISO 14971:2012 and help you avoid delays in obtaining or maintaining your CE mark for compliance to the Medical device Directive, EU Directive 93/42/EEC on Medical Devices.
This webinar will give the physician’s perspective on how documentation and medical necessity play into appropriate coding and compliance for these E/M services. How coders and auditors need to understand what certain words, phrases, orders, and clinical plans mean when a physician uses and documents them.
In this quality management system webinar attendees will learn the recent changes to ISO 13485:2016 standard in step by step process and how to implement these changes in their current quality management system to pass the quality management audit. Also attendees will gain knowledge on how to deal with ISO 9001 or any other quality management system in multidisciplinary quality management systems.
The webinar will discuss QC best practices and procedures for verifying the suitability and performance characteristics of microbiological media and reagents.
This life science product stability testing webinar will explain, in detail, the requirements of the FDA’s drug stability guidelines that are stipulated for drug products and how to design a product stability testing plan that can be applied to new or modified products in the pharmaceutical, biotechnology and medical device industries.
This webinar will discuss in detail the use of the Global Harmonization Task Forces (GHTF) and Notified Body Operations Group (NBOG) supplier guidance documents to create QA agreements. Attendees will learn best practices to ensure compliance with FDA and EU guidelines for supplier quality agreements.
This webinar will give a brief overview of the general procedure for the preparation and documentation of the Annual Product Quality Review and also focuses on the regulations and the regulatory requirements as per US and Europe.
In this webinar, learn how to develop a data integrity governance program, and the principles for defining quality and data integrity processes and systems. It will examine common issues from FDA 483 observations and explain how to prevent them.
In this care coordination training you will learn how to apply the key strategies for reducing your hospital’s cost and length of stay. Also you will learn how to appreciate the role of interdisciplinary care rounds by identifying your hospital’s strength and weakness related to care coordination.
In this webinar attendees will learn the fundamentals for reviewing batch records in a pharmaceuticals, biologics and medical devices environment. You will hear about the proper training that must be demonstrated before one is considered a suitable reviewer of these critical documents and you will learn how to react to discrepancies found in these records.
Labeling, Advertising and Promotion of drugs, biologics and medical devices are heavily regulated and aggressively reviewed on behalf of the regulators such as FDA, FTC and other Federal Authorities. This course provides an overview of label development, building a Target Product Profile, the label’s impact on advertising and promotion, and recent changes in how these areas are monitored and enforced.
In this webinar, the steam sterilization mechanism will be described as it relates to bacterial cells and endospores. The process and key terminology are defined. Understanding these fundamentals is critical to develop a successful autoclave sterilization process.
Almost every paragraph of the Quality System Regulation states that manufacturers shall “establish” procedures. Well written SOPs that are easy to understand and follow are necessary to accomplish that objective. Excellent SOPs need more than just subject matter. This webinar will help you to write complete, clear, unambiguous, and flexible SOPs. You will learn techniques for creating concise and easy to read SOPs that your employees can understand and will follow. Well written SOPs result in more consistent process outputs and quality results.
This course will focus on Regulatory Inspections and Quality Audits. It will cover Health Authority inspections as well as internal Quality Audits and also managing corrective action plans that can result from audits.
This session will discuss the issues surrounding the use of various communication technologies under HIPAA controls, and the recent guidance and declarations from HHS about HIPAA and the response to COVID-19
This training will prepare hearing officer for corrective actions and how to prepare for the hearing. It will cover application process for new applicants which include prior practice, references, prior adverse actions and liability settlements. Attendees will learn elements of good, clear and concise bylaws, fair hearing plans and other policies.
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.
This healthcare coding webinar will provide an overview of ICD-10-CM, the format and guidelines. It will also explain the differences between ICD-9 and ICD-10 to help you understand how it will affect your work and as well as your co-workers and providers.
