All FDA Regulated Industry
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, and multi-mill..
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 supplements,..
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 Safety under thi..
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 to Class ..
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 the most rece..
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..
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 pro..
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..
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 a section-by-section summary of the CAPA subsection of the QSIT, the document b..
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..
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..
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 medical dev..
Device and Software Changes and The 510(k)
This webinar will provide valuable assistance to all regulated companies performing and documenting meaningful, results-driven 510(k) / change analysis activities, based on the U.S. FDA has its current two recent “Final Guidance for Industry and FDA Staff”: “Deciding When to Submit a 510(k) for a Change to an Existing Device”; and “Deciding When to Submit a 510(k) for a Software Change to an Existing Device..
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 process, how y..
Cosmetic cGMPs, Are You Complying?
It is common for personal care product manufacturers to dismiss the importance of applying strong GMP’s to cosmetic product manufacturing. Even the best-run firms are prone to FDA oversite due to shortcomings in their operations. On the scale of FDA regulatory responsibilities, cosmetics are as low as you can go. So why worry? It is easy to forget that all of the regulatory powers given to the FDA under the..