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510(k) Submissions — 510(k) Submissions to the FDA: Hands-On Workshop
18 Apr 2024 - 19 Apr 2024 • washington dc, United States
Organizer:
FDAMap
Abstract:
Each year FDA receives about 3000 applications for new devices via the 510k process, and about 60% of them are rejected either for poor quality application that cannot even be reviewed or for other technical reasons. Submissions to the FDA that are poorly organized, do not follow current practices, contain inconsistencies between documents, have missing or incomplete content, or poor structure will result in significant delays in the clearance process. With multiple review cycles, up to 90 days each, rejections by FDA could stretch the 510k clearance time-lines to 8 months or more. Most of the refuse-to-accept deficiencies are due to the inexperience of the 510k writers, who ignore the FDA rules. Writing and assembling a complete and well structured 510(k) submission will certainly improve the likelihood of FDA clearance on the first round.
Topics:
510 K, 510 K Submission, FDA Regulation, FDA Complience
Event listing ID:
1601704
2
eCTD Submissions of IND and NDA/BLA — eCTD Submissions of IND and NDA/BLA to the US FDA: Hands-on Workshop
15 May 2024 • washington dc, United States
Organizer:
FDAMap
Abstract:
FDA now requires all DMFs be submitted only in the electronic CTD format which creates a huge burden on owners of most submissions. Converting to eCTD format requires special skills, software and resources, the cost of which could be prohibitive to small manufacturers. Our speaker, Dr. Mukesh Kumar, in this workshop will go over the details of the latest guidance on eCTD submission and explain the key takeaways.
Topics:
E CTD, E CTD Submissions, FDA Compliance, FDA Regulation
Event listing ID:
1601681
3
FDA Compliant SOPs for Regulated Industry — FDA Compliant SOPs for Regulated Industry: How to Create High Quality SOPs that Your Team and FDA Auditors Will Love
23 May 2024 - 24 May 2024 • washington dc, United States
Organizer:
FDAMap
Abstract:
SOP deficiencies are one of the top 5 findings in FDA audits. The entire Quality Management System (QMS) of an organization could be severely compromised due to SOP defects. Formal written Standard Operating Procedures (SOPs) are required both by the FDA and EMA. Almost every deficiency identified in FDA’s 483s and Warning Letters can be traced back to deficiencies in SOPs at an organization. SOPs are often inadequate, miss important elements, do not contain important tools to increase compliance with the SOPs and, many times, are hard for the personnel who follow them to understand. They are frequently poorly written, communicated, monitored and enforced. This workshop will provide step by step instructions to create SOPs for FDA-regulated organizations.
Topics:
FDA, SOPs, Quality Management System, Clinical Trials, Clinical Studies, Clinical Research, Clinical Development, FDA Regulation, FDA Complience
Event listing ID:
1601779


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Last updated: 21 January 2024