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COVID-19 Hand Sanitizer: Temporary FDA Registration & Listing Purchase this package for FDA Establishment Registration and Product Listing if you are a US based company.   If you need NSF as your US Agent, please use the following link to purchase the version with US Agent Services. COVID-19 Hand Sanitizer: Temporary FDA Registration & Listing - Includes US Agent Service: https://nsfmedicaldevices.trainingfolks.com/store/819777-covid-19-hand-sanitizer-temporary-fda-registration-listing-includes-us-agent-service-511-a   Below is a recording of a webinar by Maxine Fritz and Ori Dezsi about FDA's policy for Hand Sanitizer.   ENGLISH SPANISH   Read More

COVID-19 Hand Sanitizer: Temporary FDA Registration & Listing – Includes US Agent Service (511-A) Purchase this package for FDA Establishment Registration and Product Listing if your business is located outside of the US and you require NSF to serve as your US Agent (a requirement for non-US company seeking to market drug product in the US).   If you do not need NSF to be your US Agent, please use the following link to purchase the version without US Agent Services. COVID-19 Hand Sanitizer: Temporary FDA Registration & Listing: https://nsfmedicaldevices.trainingfolks.com/store/819849-covid-19-hand-sanitizer-temporary-fda-registration-listing-511   Below is a recording of a webinar by Maxine Fritz and Ori Dezsi about FDA's policy for Hand Sanitizer. ENGLISH SPANISH   Read More

Problems with data integrity continue to lead to vigorous regulatory actions. Such issues can be prevented with a thorough knowledge and understanding of the regulators’ requirements.  This eLearning course is aimed at anyone working in the Pharmaceutical Industry and provides an overview of what is meant by data integrity, what needs to be considered during documentation completion, review and approval and how to keep your data complete, consistent and accurate throughout the data lifecycle. Read More

Module 2 of our Data Integrity Series This course (module 2) will build on the key messages of module 1 and go beyond the basics.  It will look at some more specialised or particular aspects of this topic which has such wide ranging impact.  This course consolidates knowledge and experience of 11 years work from an ex MHRA Inspector.  Management and the Quality Unit need to have a deeper understanding of Data Integrity to give them the confidence to get involved and this module is designed to highlight the known weaknesses in company systems.   This course is module 2 of our Data Integrity series of courses.  We would suggest that prior to this course you take module 1, Data Integrity: Overview and Documentation Completion, Review and Approval course.   Read More

Module 3 of our Data Integrity Series Data Integrity Module 1, Basics of Data Integrity addressed what everyone needs to know for this essential topic.  Module 2 went beyond the basics focusing on the technical details for subjects such as auditing and computer systems management. In this third Module we build on your essential knowledge to understand what the Senior Management should ensure is in place, in use and effective. Read More

The FDA is aware of some confusion surrounding the guidance, Deciding When to Submit a New 510(k) for a Change to an Existing Device. As such, FDA has worked diligently over the past few years to enhance predictability, consistency and transparency while maintaining a “least burdensome approach.” The new updated guidance provides greater detail of the regulatory framework, policies and practices underlying FDA’s decision-making process and provides much needed clarity for industry on FDA’s expectations. In this course we walk through these changes and discuss how to determine when to submit. Read More

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