Clinical Trial and Clinical Research
International Codes and Medical Device Reporting
The US FDA receives over 100,000 reports a year of medical device adverse events including deaths, serious injuries, and malfunctions. Because of this high number of reports, the FDA sought ways to sort the data using hierarchical coding systems that included a device problems code; a manufacturer’s evaluation for the event: methods, result, and conclusion; and also information on the patient and the device..
Is Your Quality Management System Up to Date for the New European Medical Device Regulation Starting in May 2020?
The EU MDR 745/2017 is a complete game-changer to the old law of the MDD 93/42/EEC since 1993 with a couple of updates. The time is very short and the number of requirements and required changes is high. The training will show, how to conduct a gap analysis, an action plan and how to be on track until May 2020. Learn, what to do into the quality management department and what to do in the regulatory affairs..
Laboratory Investigation of Out-of-Specification (OOS) Results
Inadequate investigation of out-of-specification (OOS) results in the laboratory is a common observation cited in FDA 483s and Warning Letters. It is clear that regulatory investigators throughout the world are looking at laboratory operations very closely. Specifically, there is a concern as to whether the laboratory and the company apply good science to the investigation of laboratory test results that ar..
Legal, Regulatory and Policy Issues Related to Validation of Computer Systems Regulated by FDA
We will discuss the importance of applying industry best practices when performing the validation process for a computerized system used in an FDA-regulated environment (i.e., the system "touches" product during the manufacturing, testing or distribution process). Such a system must be validated in accordance with FDA guidelines for computerized systems and documented accordingly. There are legal, regulator..
Managing an FDA Foreign Inspection
Agreeing to an FDA foreign inspection requires careful preparation on a firm’s part. If you do not manage your inspection wisely, you will set yourself up for disaster. We will cover fundamental issues, such as pre-inspection tasks, preparing your documents and having an interpreter before, during and after the inspection. We will also address how you should respond to inspectional problems noted by the FDA..
Managing The Audit Function In A Global Company
Whether your company is small or large each should have at least one independent yet experienced individual or department that can be relied on to resolve issues from these and other perspectives: quality assurance, regulatory affairs, and corporate risk management. While companies rely on audits to remain in compliance everyone is eventually faced with a complex issue that requires examination from an..
Managing the Transportation of Perishable Food Products
This session is designed for any food industry supply chain players who rely on transportation delivery controls. Air Cargo, trucking, rail, freight forwarders, shippers and others in the food supply chain are key players in the transportation of temperature and humidity-controlled food goods and can benefit financially from offering sanitary and value-added sensor technology to their service packages. The ..
Mathematics of Terminal Sterilization - Probability of Survival Approach -vs- Overkill Approach
Heat sterilization is a PROBABILITY function dependent on heat exposure, the number of microorganisms, and the heat resistance of the microorganisms. Current regulations expect the sterilization process to provide a level of assurance of at least 1 x 10-6 probability (fewer than one non-sterile unit per million units) of survival (non-sterility) for terminally sterilized parenteral and medical devices. Sinc..
Medical Device Recall Management
Despite best efforts, serious quality issues resulting in the recall can occur. Medical Device companies need to be prepared in advance to handle a difficult situation. This webinar will prepare you to understand the signals that trigger a need to recall, the investigation and other actions required, taking corrective and preventive action, and notifications to customers and regulatory bodies.This webinar w..
Medical Device Risk Management Following ISO 14971:2019
The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA also expects that a post-production risk management program is implemented. FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard. Hazard Analysis is described in ISO 14971. This is the most powerful of the risk management techniques because it considers ris..
Medical Device Software 62304 Compliance
The webinar will leave you with the information needed to create and maintain good documentation that meets FDA compliance standards. You will learn about what must be done and what must not be done. In addition, you’ll learn about the various computer system validation deliverables and how to document them. This session will provide insight into the IEC 62304 standard as it is applied to medical device sof..
Modeling and Optimizing Process/Product Behavior using Design of Experiments
Experimentation is frequently performed using trial and error approaches which are extremely inefficient and rarely lead to optimal solutions. Furthermore, when it’s desired to understand the effect of multiple variables on an outcome (response), “one-factor-at-a-time” trials are often performed. Not only is this approach inefficient, but it also inhibits the ability to understand and model how multip..
Navigating California Prop 65 Incorporating FSMA Preventative Controls, Best Practice Approach
Highlights will include an intro to Preventative Controls, leading into minimal recommended preparation steps for handling Prop 65 requirements, what’s needed to incorporate in your food Safety Plan, focus on hazards or Hazard Analysis Risk Preventative Controls (HARPC), Supply chain Preventative Controls and importance of compliance on Safe Harbor Limits.Areas Covered Details will includ..
New FDA and EMA Labeling Requirements for Regulated Industries
This webinar will help you understand in detail the new requirements for labeling from FDA and EMA, including a set of rules for electronic submission of labeling content, and strategies and actions for meeting the new challenges posed.Pharmaceutical companies must manage the process of designing and creating product labels that meet regulatory requirements. This includes product-labeling documents such as ..
New ISO14971: 2019 Risk Management Standard for Medical Devices – Implementation
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 device products. This process has been streamlined within ISO14971 standard and has become the best practice to show the application of risk-based approach implementation..