Mr. Yuval Shapiro shall present the requirements for Corrective and Preventive actions as required by medical devices standards (ISO13485, etc.) and the common practice.The difference between Correction, Corrective Action and Preventive Action will be discussed.Mr. Shapiro shall present common sources for CAPA, tools for root-cause-analysis, e.g. – 5 Why, Cause and Effect Diagram, Pareto Charts, etc.Also, w..
The Use of Statistical Process Control (SPC) Using Control Charts to Maintain Compliance in the Laboratory
Compliance under GLP can be difficult. The setting up of a system to monitor the performance of methods and instruments can lessen this. Statistical Process Control (SPC) uses control charts and statistical guidelines to monitor a wide variety of things in the compliant laboratory. These generate a proactive system to assess problems early on and quickly to be handled by adjustments rather than the strict s..
This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health, organ donation, and tobacco. Functions that are applicable include research and development, clinical sample manufacturing, packaging, labeling and distribution, clinical testing and management, adverse events management, and post-marketing surveillance. You should..
This seminar will provide an overview of environmental monitoring investigations and tools to complete an investigation. Environmental monitoring is the method by which clean rooms are known to maintain a certain level of cleanliness. The methods by which clean rooms are monitored are through viable and non-viable testing. Through this testing, a room may demonstrate that it is out of control. This seminar ..
Design Control is essentially a quality assurance program for the Research and Development department. The VP or Director of research and development owns the design control effort. Over the years many companies have included the design control requirements into their project plans and build the Design History File as part of the development process. Nothing has changed in these basics, but FDA’s and ISO’s ..
The EU Medical Device Regulation (MDR 745/2017) represents a considerable change from the directives it is replacing. Device manufacturers who conduct business in the EU must start their transition now in order to meet the deadline. This training is the first peek into this uncharted realm. During this class participants will be introduced to the new requirements in the Medical Device Regulation (MDR), incl..
Mr. Shapiro shall present the basic principles and practices of Risk Management and Risk Analysis.The risk-based approach has become a key element of quality management and as a fundamental process in the design and development of medical devices product.This process has been streamlined within ISO14971 standard and has become the best practice to show application of risk-based approach implementation in th..
Computer Software Assurance (CSA) – FDA’s Draft Guidance for Validation of Regulated Computer Systems
Advancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges.The approach to developing software, performing validation and maintaining a syst..
This webinar will focus on the efforts by FDA to modernize their own technology infrastructure, and what this means to industry. We will cover the Technology Modernization Action Plan (TMAP) that has been launched by FDA for this purpose and discuss specific actions that are planned and in progress.We will also discuss FDA’s more recent push to Software Quality Assurance (SQA) and away from traditional Comp..
FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC and GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on computer systems that are validated and subject to inspection and audit.As a “GxP” system, following Good Manufacturing, Laboratory and Clinical Practices, the ..
This webinar will help you understand in detail the application of FDA’s guidance on the use of social media in presenting and promoting information about drug products and medical devices subject to FDA regulation. This is critical in order to develop the appropriate strategy, policies and procedures to ensure compliance.Areas CoveredPros and cons of using social media venuesCompliant use of Social Media i..
Computer System Validation (CSV) And Software Testing: Applying An Agile Methodology vs. Waterfall For FDA-Regulated Computer Systems And Software
Advancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges. The approach to developing software, performing validation, and maintaining a sy..
Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance. A strong batch record review system is essential in order to properly document all critical processing parameters that go along with the production a..
This course will help attendees understand the fundamental change control steps and processes. It will focus on change proposals, assessments, execution, and final implementation. The importance of proper planning, critical thinking skills, and coordination of all change activities will also be discussed.Learning ObjectiveIdentify what constitutes a changeLearn how to properly categorize a changeDemonstrate..
This session will provide some insight into current trends in cybersecurity threats to medical devices and how to follow industry best practices to prevent and/or mitigate these threats.Cybersecurity is a serious concern for medical device safety and effectiveness. Without protection, software running on a medical device could cause severe injury or death to a patient.There are many forms of cybersecurity a..