Medical Devices

Medical devices benefit patients by helping healthcare providers diagnose and treat patients and help patients overcome sickness or disease or improve their quality of life. Significant potential for hazards is inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. In the USA Federal Food, Drug, and Cosmetic Act regulates medical devices. Medical devices in Europe are regulated by MDR.

$179.00

 July 30 2021

 01 : 00 PM EST    

 60 Minutes

Avoiding 483s Throughout Your Organization – Strategies, Risk, and Mitigating Approaches

Certainly, the most simplistic solution to achieving compliance excellence and 483 avoidance is “to do the right things right!” But what does this really mean?I have distilled the “doing the right things right” solution into 7 separate individual keys or actions that will provide a solid foundation for the establishment of any 483 avoidance program. Why should you attend this Webinar? Because as..

$179.00

 August 10 2021

 01 : 00 PM EST    

 90 Minutes

Avoid 483 Observations and Warning Letters

U. S. FDA-regulated companies are responsible for understanding current Good Manufacturing Practices (CGMPs) as defined in the Code of Federal Regulations ( 21 CFR Part 111, 210/211, and 820), plus “current”. They are then required to translate those regulations into procedures and work instructions. Many companies who are successfully doing that are still failing audits, facing major recall, an..

$179.00

 August 10 2021

 02 : 00 PM EST    

 60 Minutes

Gray Areas in Cosmetic Regulation. Marketing Claims That Avoid Regulatory Issues

FDA has a history of avoiding discussion of popular issues and leaving the course of history to the imagination of industry to push the boundaries of regulatory compliance. The unwillingness by FDA to address issues like “natural”, “probiotic”, “CBD” and other popular issues, creates an opportunity to add market potential, but it also creates hazards to avoid for FDA-regulated products. Dietary ..

$179.00

 August 10 2021

 01 : 00 PM EST    

 60 Minutes

Transitioning FCPA and Other Temporary Regulations Under the New Normal for the Food Industry

The COVID-19 crisis has brought extraordinary strains to business practices and compliant supply chains. Ensure your organization is protected before and during an investigation. Join us by registering today. The current pandemic has forced regulators and industry to rethink how to achieve Food Safety surveillance and compliance for the industry with Supply Chain, Transportation, and Worker Safe..

$179.00

 August 13 2021

 01 : 00 PM EST    

 60 Minutes

De Novo Classification Process

Unlike other countries in the world, the US uses a predicate-based system to classify its medical devices. For devices that have a predicate device in the marketplace, the classification process is quite straightforward. A predicate device is a legally marketed device, called a preamendments device, that was legally marketed prior to May 28, 1976, a device that has been reclassified from Class III..

$300.00

 August 16 2021

 01 : 00 PM EST    

 180 Minutes

Food Labeling In MX

General Mexican labeling specifications for pre-packaged foods and non-alcoholic beverages have been submitted to different changes due to health policies in Mexico. In order to comply with the new guidelines, you’ll need to cover numerous rules, standards, and some other regulations.Receive the most up-to-date information first-hand from an industry expert that collaborated through the ICC in t..

$179.00

 August 17 2021

 01 : 00 PM EST    

 60 Minutes

Medical Device Software Validation that Meets FDA Regulations

This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis invalidation. How software requirements are developed and used in validation will be described.Learning ObjectivesHow to validate medical device software in compliance with FDA objectivesSoftware v..

$179.00

 August 18 2021

 01 : 00 PM EST    

 60 Minutes

Best Practices for Deviation Training

Deviation investigations are a very common topic to be reviewed during FDA investigations. Ensuring the firm has robust and complete write-ups of these situations is key to a successful audit. Having inadequate investigations could potentially cause some severe issues for the company and may sometimes result in warning letters, consent decrees, or recalls.Learning ObjectivesDiscuss what to do when problems ..

$179.00

 August 18 2021

 03 : 00 PM EST    

 90 Minutes

Data Integrity And Governance For Computer Systems Regulated By FDA

Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. During the past 30 years, best practices that have been developed will ensure that validation activities are cost-effective while meeting all aspects of FDA compliance. While these practices have been employed, companies are being forced to do more work with fewer resources, leading to errors ..

$179.00

 August 18 2021

 01 : 00 PM EST    

 60 Minutes

Medical Device Software per IEC 62304

This course is essential for Medical Device companies interested in submitting software-enabled medical Devices or Software as a Medical Device to the FDA for 510K approval. One of the biggest risks most company's face when submitting their device for approval is finding out after seven or more months of waiting that the 510K has been denied because the software portion of the submittal is inadequate and no..

$179.00

 August 20 2021

 01 : 00 PM EST    

 60 Minutes

How FDA Trains its Investigators to Review CAPA and What Should You do to Prepare

During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss all the documents used by the FDA to train their inspectors to review your CAPA system, some of which you may not be familiar with. Also contained in this session will be a section-by-section summary of the CAPA subsection of the QSIT, the document by wh..

$179.00

 August 24 2021

 01 : 00 PM EST    

 60 Minutes

Sterilization of Pharmaceutical Products and Medical Devices

Pharmaceutical products and medical devices are required to be sterile to be used in patients. Sterilization of these crucial products can be done in several ways depending on the characteristics of the product being sterilized. There are four typical ways a product can be sterilized. These are sterilization by Ethylene Oxide, Gamma irradiation, Steam and Pressure, and filtration. Knowing the characteristic..

$179.00

 August 25 2021

 01 : 00 PM EST    

 60 Minutes

Method Validation of HPLC/UPLC Methods

Instrumental liquid chromatography, either as HPLC or UPLC, are a common technique in laboratories that do regulatory-compliance work. For Good Laboratory Practice (GLP) or for ISO 17025 compliance, such methods must meet certain requirements. This presentation will cover the key elements to have a compliant method.Instrumental liquid chromatography is an analysis that is widely used to determine purity, im..

$179.00

 August 30 2021

 01 : 00 PM EST    

 60 Minutes

Usability Engineering Under IEC 62366

ANSI/AAMI/IEC 62366 is a Recognized Consensus Standard by the US FDA and a harmonized standard in the EU. This means that compliance to it provides a presumption of conformity to the requirements within those jurisdictions. Compliance with the standard helps both ensure a smooth path to market clearance and drives a safer product.IEC 62366 is the recognized standard for Usability Engineering for m..

$179.00

 September 10 2021

 01 : 00 PM EST    

 60 Minutes

Classifying Medical Devices in the US and the EU

The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels. Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device. The determination pr..

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