Submissions and Approvals

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Increase Compliance, Reduce Risk with Integrated Digital Solutions – Webinar Recording/ Transcript

$287.00
Your connected technology — the integration of your electronic document management, training management, risk mitigation, risk management, deviation and CAPA management, and audit management systems — will trigger the kinds of checks and balances across systems that increase compliance and reduce risk. View

Understanding UDI in EU Device Regulations – Webinar Recording/Transcript

$287.00
EU device regs are an ongoing compliance headache but one thorny issue — UDI compliance deadlines for Class I and unclassified devices — is upcoming. When next May rolls around, will you be ready? View

How to Address Medical Device Sample Size Issues – Webinar Recording/ Transcript

$287.00
More 483s are being issued for violation of 21 CFR 820.200, statistical methods — most often for a lack of statistical justification for sampling plans. Design control statistical expert Steve Walfish is here to explain how to address your sample size issues. View

Labeling for Prescription Drugs, Biologics and Combination Products – Webinar Recording/ Transcript

$287.00
What implications does the recent Instructions for Use (IFU) guidance have on your new drug applications and biologics license applications? Alan G. Minsk, Esq. — a partner and leader of the Food & Drug Practice Team of Arnall Golden Gregory LLP — will clarify the new guidance and explain how to comply with it. View

Medical Device Warning Letters – Webinar Recording/Transcript

$287.00
Are you protected from the Forgotten Five most cited warning letter observations? If you’re not sure, you’re not alone. The Forgotten Five are not frequently discussed and have not generated much corrective information. In other words, the Forgotten Five are the highest-risk areas that offer you the most potential to prevent inspection issues. View

Clarity on Clinical Investigations – Webinar Recording/Transcript

$287.00
The world of clinical investigations is changing rapidly, with the EU-MDR’s new and more complex system and the forthcoming ISO/DIS 14155:2018 updates. This presentation will provide insight into the EU-MDR’s extensive requirements for documenting, conducting and reporting clinical investigations, including which devices are exempt. View

510(k) Change Analysis – Webinar Recording/Transcript

$287.00
The FDA’s 510(k) design change guidance documents are not the easiest to understand and incorporate. While the guidance’s flowcharts were designed to help guide evaluation and decision-making, they can instead be confusing. This presentation will provide you with a clear understanding of the decision paths and processes. View

Nine-Volume Title 21 CFR Set 2019

$585.00
The federal government has compiled the new 2019 CFR volumes.






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Wearables and Sensors – Webinar Recording/Transcript

$287.00
The rapidly evolving landscape for wearables and sensors is having a mighty impact. Former FDA staff member Sugato De, MS — Vice President, Parexel International — and regulatory expert Peter Steiger — Vice President, Parexel Informatics — will explain what you need to know and share management strategies to make it all work for your organization View

Animal Tissue Use in Medical Devices – Webinar Recording/Transcript

$287.00
Implementing compliant systems for medical devices with animal tissue requires multiple control layers, typically using standards in the ISO 22442 family — some of which are under revision. View

European Medical Device Regulations (EU MDR) - Webinar Recording/Transcript

$287.00
Devicemakers face a market upheaval in the EU. A new set of rules — the Medical Device Regulation (MDR) — will soon supplant the longstanding Medical Device Directive, forever changing how you sell medical devices in EU nations. View

Organizing Data and Document Archives - Webinar Recording/Transcript

$487.00
Are your documents as organized as you think they are? Can you easily put your hands on the documents FDA investigators request? Or are you searching for that needle in a haystack? View