Medical Devices
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Managing Product Corrections & Removals in Accordance with 21 CFR, Part 806
Description: Compliance with 21 CFR, Part 806 (Medical Devices; Reports of Corrections and Removals) is not optional for device manufacturers wanting to enter medical devices into commerce in the United States. Compliance is driven, in part, by recall classification... -
Understanding the FDA’s Quality System Regulation, 21 CFR, Part 820
Description: Compliance with 21 CFR, Part 820 (the FDA’s Quality System Regulation) is not optional for device manufacturers wanting to enter medical devices into commerce in the United States. Compliance is driven, in part, by device classification (three device... -
Effective Purchasing & Supplier Controls in Accordance with 21 CFR, Part 820.50
Description: Lack of an effective approach to purchasing controls and supplier management is one of the more frequent Form 483 observations cited during FDA device establishment inspections. Additionally, problems with purchasing controls are typically rooted in a lack of... -
A Robust Approach to Validation in Compliance with 21 CFR, Part 820.75
Description: Regardless or regulatory environment, United States or OUS, the validation of processes, which cannot be verified through inspection or test, is considered a salient requirement for medical device establishments. It is imperative that processes are capable of producing... -
Effective Design Control for Medical Device (21 CFR, Part 820.30)
Description: All industry professionals, regardless of functional roles, will benefit from this training, especially if you are involved in the day-to-day activities associated with your organization’s design and development process and/or sits on design and development teams. The effective... -
Managing Product Recalls in Accordance with Part 806
Description: It is inevitable that eventually a device manufacturer will need to execute a correction or market-withdraw for a medical device. The actual process of managing a market-withdraw is time consuming; and if poorly executed can result in a... -
Establishing a Robust Complaint Management System
Description: Lack of an effective complaint management system is one of the more frequent Form 483 observations cited during FDA device establishment inspections. In fact, failure to process complaints in a timely and uniform manner will quickly lead to... -
FDA’s New Guidance On Medical Device Development Tools (MDDT)
Description: This webinar will discuss a voluntary process for qualification of Medical Device Development Tools (MDDT) for use in device development. An MDDT is a scientifically validated tool (test) to determine clinical outcome. Qualification reflects CDRH (FDA’s) expectation that... -
The FDA 510(k) and Q-Submission: Best Practices
Description: This webinar will provide an opportunity to get familiar with an FDA’s process to communicate with the industry early in the process for sustainable 510(k) preparation and submission. This webinar is intended to discuss how to put together... -
Best Practices for Medical Device Recalls
Description: In the United States, medical device firms are subject to compliance to the FDA regulations of device recalls, correction and removals. To achieve compliance and to remain compliant, it is critical to understand how to establish and maintain... -
Best Practices for 510(k) Drafting and Submission: Dos and Don’ts
From this webinar you will learn best practices for adequately putting your 510(k) together for your successful submission to the FDA, compliant with the FDA’s eCopy and RTA policy. This session will greatly help you streamline your 510(k) preparation... -
Current Good Manufacturing Practices (cGMP) for Medical Devices and IVDs
Description: The US Food and Drug Administration (FDA) states in warning letters “this inspection revealed that these devices are adulterated within the meaning of section 510(h) of the FD&C Act, in that the methods used in, or the facilities... -
Statistical Process Control (SPC)
Description: All companies want to improve the quality of their products. Attempts to improve product quality need to be structured in such a way that they have a reasonable chance of success and the cost/benefit ratio is appropriate. The... -
Normality Tests and Normality Transformations
Description: The calculations used in many statistical tests and methods require that the inputted data be “normally distributed”. Such calculations include those for t-Tests, ANOVA tables, F-tests, Tolerance limits, and Process Capability Indices. Unless the raw data used in... -
Process Capability Analysis using Confidence/Reliability Calculations
Description: All manufacturing and development companies perform testing and/or inspections that involve concluding whether or not a product or lot is acceptable vs. design or QC specifications. Such test/inspections may occur during design verification/validation or during incoming or final... -
Master Validation Planning To Meet U.S. FDA cGMP, ISO 13485, and ICH Q9 / ISO 14971 Requirements
Description: This 90 minute in-depth webinar discusses the FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in big name device and pharma companies, many going back to insufficient, poor or non-existent V&V planning. And now, the...