Conférences - Système de santé, gestion hospitalière - États-Unis

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1
Navigating through Maze of In-vitro Diagnostics (IVD) Regulations: A systematic approach from Regulatory Strategy to Regulatory Approvals in U.S./Europe/Canada
20 aou 2020 - 21 aou 2020 • Boston, MA, États-Unis
Organisateur:
Complianceonline
Résumé:
In-vitro Diagnostics (IVD) products provide critical information on patient’s health condition, based on which the healthcare provider develops and administers treatment plan. Although IVDs are medical devices, they are regulated under a separate set of regulations in U.S., Europe, and Canada.

This 2 day interactive course on in-vitro diagnostics is structured to understand the different set of IVD regulations, how to navigate through this maze of IVD regulations, and to win regulatory approvals. This In-vitro Diagnostics (IVD ) course will make the attendees understand the IVD regulations and develop regulatory strategies that secure regulatory approvals.

Contact:
Tél.: [8887172436];     Email.: referral@complianceonline.com
Sujets:
In-vitro Diagnostics, IVD regulations, European IVD regulations, Canadian IVD requirements, US in-vitro diagnostic regulations, IVD labeling requirements, Canadian medical device regulations, content of 510(k), Pre-IDE, IDE and PMA
Identifiant de l'évènement:
1353352
2
Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH).
21 sep 2020 - 22 sep 2020 • Philadelphia, PA, États-Unis
Organisateur:
Complianceonline
Résumé:
Analytical methods should be validated to ensure the reliability, consistency and accuracy of analytical data. Compendial methods should be verified to demonstrate the suitability of laboratories to successfully run the method and when methods are transferred between laboratories successful transfer should be demonstrated through testing or a transfer waiver, if justified. If a laboratory uses an alternative method instead of a compendial method, equivalence or superiority of the alternative method should be demonstrated.
Contact:
Tél.: [8887172436];     Email.: referral@complianceonline.com
Sujets:
Laboratory compliance, Analytical methods, data, procedures, compendial methods, Method validation and transfer, equivalency testing, FDA inspection, SOPs, FDA and EU compliance, documentation, ICH Q2, USP chapters 220, 1200, 1210, 1220, USP, >, GLP, GCP, GMP, FDA Warning Letters, Part 11, Annex 11, LOD, LOQ, HPLC to UHPLC, INDA, ANDA, NDA submissions, QbD, statistical evaluation, Training by, Analytic Lab workshop
Identifiant de l'évènement:
1353876
3
Laboratory Inspection and Auditing
23 sep 2020 • Philadelphia, PA, États-Unis
Organisateur:
Complianceonline
Résumé:
Quality auditing of pharmaceutical quality control laboratories is an important activity for those performing due diligence or monitoring the performance of a sub-contractor. Besides covering GMP regulations affecting pharmaceutical quality control, this one-day course is designed to provide the non-specialist with the necessary knowledge to understand the quality significance and risk associated with different analytical operations.
Contact:
Tél.: [18887172436];     Email.: referral@complianceonline.com
Sujets:
"Lab safety audit checklist, laboratory audit checklist, chemical laboratory audit checklist, pharmaceutical quality assurance, pharmaceutical guidelines for quality assurance, quality control of drugs, gmp guidelines for pharmaceuticals, laboratory inspection
Identifiant de l'évènement:
1324769


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Dernière mise à jour: 08 Mai 2020