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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 mai 2024 - 24 mai 2024 • washington dc, États-Unis
Organisateur:
FDAMap
Résumé:
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.
Sujets:
FDA, SOPs, Quality Management System, Clinical Trials, Clinical Studies, Clinical Research, Clinical Development, FDA Regulation, FDA Complience
Identifiant de l'évènement:
1601724
2
510(k) Submissions — 510(k) Submissions to the FDA: Hands-On Workshop
30 mai 2024 - 31 mai 2024 • Washington DC, États-Unis
Organisateur:
FDAMap
Résumé:
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.

This hands-on workshop is done by one of the industry’s top regulatory expert. The trainer has performed numerous reviews of 510(k) submissions over the last 15 years, and has analyzed the reasons that most often lead to delays in getting submissions ultimately cleared by FDA. This hands-on workshop will walk the attendees through the structure and key elements of the 510(k) submission and explains in clear language the most common pitfalls to avoid in the development of your 510(k) submission to the FDA.

Sujets:
FDA, 510 K Submission, 510 K Writers, FDA Compliance, FDA Regulations,
Identifiant de l'évènement:
1616016
3
ipharma@2024 — International Pharmaceutical Business Expo 2024
16 aou 2024 - 17 aou 2024 • Boston, États-Unis
Organisateur:
i Pharma Expo
Résumé:
iPharma Expo 2024, USA (International Pharmaceutical Business Expo 2024) scheduled during August 16- 17, 2024 , at Boston, USA.
Contact:
Tél.: [(617) 275-2612];     Email.: kathy@ipharmaexpo.net
Sujets:
Pharma Expo, pharma congress, pharma Expo USA, pharmaceutical event, pharma USA, pharmaceutical expo, international pharma, iPharma USA
Identifiant de l'évènement:
1613201
4
Biomarkers US 2024
28 oct 2024 - 29 oct 2024 • San Diego, Californie, États-Unis
Organisateur:
Oxford Global Conferences
Résumé:
Discover the latest advancements in biomarkers at the 8th Annual Biomarker & Precision Medicine US Congress. Join experts from global pharma, top biotechs, and renowned academic institutions to delve into emerging tools and strategies in translational science, diagnostics, and biomarker development.
Contact:
Marketing Executive;     Email.: l.staplehurst@oxfordglobal.com
Sujets:
Novel Biomarker Discovery, Identification & Characterization, Effective Clinical Biomarker Strategies, Multi-Omics For Precision Medicine, Emerging Strategies For Biomarker Validation & Data Analysis, High-Quality Biospecimens in Clinical Development & Precision Medicine, Innovative Tools & Technologies For Next-Gen Diagnostics
Identifiant de l'évènement:
1616097


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Dernière mise à jour: 19 avril 2024