Konferenzen zum Thema Gesundheitssystem und Krankenhausverwaltung in den Vereinigten Staaten (USA)

Wählen Sie ein Land aus
1
Risk Management in Medical Devices Industry
04. Jun 2020 - 05. Jun 2020 • Boston, MA, Vereinigte Staaten
Veranstalter:
Complianceonline
Zusammenfassung:
Risk management is a mandatory and necessary process during the entire device life. Not only will it help to design and maintain devices efficiently, but it also ensures that the device will be as safe as possible and prevents harms to patients, users, and the environment. Like any process that tries to produce repeatable and consistent results, the risk management process must be clearly understood, including the strengths but also the limitations.By attending this seminar you will learn the main elements of ISO 14971, ISO 13485, IEC62304, IEC62366-1/-2, risk management life cycle steps and benefits, and FDA software reviewers' guidance.
Kontakt:
Tel.: [18887172436];     Email: referral@complianceonline.com
Themen:
medical device risk management training, ISO 14971 workshop, ISO 13485, quality system integration, IEC62304, IEC62366-1/-2, risk management life cycle, FDA software reviewers' guidance, SOP framework, risk rating methods, european special requirements, risk management report
Eintrags-ID:
1333825
Verwandte Fachgebiete:
2
Ensuring Compliance with Advertising and Promotional Requirements for Drugs and Medical Devices
04. Jun 2020 - 05. Jun 2020 • Boston, MA, Vereinigte Staaten
Veranstalter:
Complianceonline
Zusammenfassung:
Federal regulation of the advertising and promotion of pharmaceuticals and medical devices reflects an aggressive attitude on the part of the regulators that demands, in turn, that industry be keenly aware of the legal and regulatory duties, as well as key recent trends in enforcement activities by the Federal Government. This course will explore in detail what FDA requires of drug and device firms as well as recent current hot buttons in FDA enforcement activity for the advertising arena.
Kontakt:
Tel.: [18887172436];     Email: referral@complianceonline.com
Themen:
FDA training seminar, FTC advertising seminar, advertising drugs, advertising medical devices, promotion drugs, promoting medical devices, FTC advertising rules, FDA marketing rules, False Claims Act, Off-Label Statements, Drugs social media marketing, medical device social media marketing, Rx Drug Advertising, OTC drug advertising
Eintrags-ID:
1336138
3
Navigating through Maze of In-vitro Diagnostics (IVD) Regulations: A systematic approach from Regulatory Strategy to Regulatory Approvals in U.S./Europe/Canada
20. Aug 2020 - 21. Aug 2020 • Boston, MA, Vereinigte Staaten
Veranstalter:
Complianceonline
Zusammenfassung:
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.

Kontakt:
Tel.: [8887172436];     Email: referral@complianceonline.com
Themen:
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
Eintrags-ID:
1353363
4
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, Vereinigte Staaten
Veranstalter:
Complianceonline
Zusammenfassung:
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.
Kontakt:
Tel.: [8887172436];     Email: referral@complianceonline.com
Themen:
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
Eintrags-ID:
1353876
5
Laboratory Inspection and Auditing
23. Sep 2020 • Philadelphia, PA, Vereinigte Staaten
Veranstalter:
Complianceonline
Zusammenfassung:
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.
Kontakt:
Tel.: [18887172436];     Email: referral@complianceonline.com
Themen:
"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
Eintrags-ID:
1324714


Conference-Service.com stellt der Öffentlichkeit ein Kalendarium wichtiger Konferenzen, Symposien und sonstiger Tagungen im wissenschaftlich-technischen Bereich zur Verfügung. Obwohl das Verzeichnis mit großer Sorgfalt zusammengestellt und ständig aktualisiert wird, weisen wir auf die Möglichkeit von Fehlern ausdrücklich hin. Bitte vergewissern Sie sich immer beim Veranstalter, bevor Sie über die Teilnahme oder Nichtteilnahme an einer Konferenz entscheiden.

Stand vom 08. Mai 2020