Konferenzen zum Thema Legislation in der Medizin und Pharmakologie in den Vereinigten Staaten (USA)

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1
Managing GMP Compliance and Phase Appropriate GMP Considerations for Virtual Companies
01. Mär 2021 - 02. Mär 2021 • SanJose – online, Vereinigte Staaten
Veranstalter:
Complianceonline
Zusammenfassung:
This program combines general considerations for Good Manufacturing Practice (GMP) compliance management with the principles of phase-appropriate GMP considerations, with an emphasis on needs of virtual companies. (“Virtual companies” are those who outsource GMP operations to Contract Manufacturing Organizations (CMOs) and Contract Analytical Laboratories.)
Kontakt:
Tel.: [+1-888-717-2436];     Email: referral@complianceonline.com
Themen:
phase appropriate gmp, fda gmp workshop, FDA GMP Expectations, Phase I, First-in-Man Clinical Trials, CMC Requirements, IND Study, Raw Material Management, 505(b)(2) Products process Validation, ISO 9001:2015 QMS, Combination Products
Eintrags-ID:
1409926
Verwandte Fachgebiete:
2
Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance
03. Mär 2021 • SanJose – online, Vereinigte Staaten
Veranstalter:
Complianceonline
Zusammenfassung:
Learn how to use Microsoft Excel spreadsheets for GXP data to ensure compliance with 21 CFR Part 11 and reduce validation cost and time.
Kontakt:
Tel.: [+1-888-717-2436];     Email: referral@complianceonline.com
Themen:
Excel Spreadsheet Validation, 21 CFR Part 11 Compliance, Develop and Validate Excel Spreadsheets, GxP compliant Excel spreadsheets, Excel for audit trails, spreadsheet security features, data entry verification
Eintrags-ID:
1409822
Verwandte Fachgebiete:
3
Designing and Sustaining New and Existing Product Stability Testing Program
03. Mär 2021 - 04. Mär 2021 • SanJose – online, Vereinigte Staaten
Veranstalter:
Complianceonline
Zusammenfassung:
This Virtual Seminar will provide a great resource to Pharmaceutical, Biotechnology, Diagnostics, Cell Therapy, Drugs, Biologics, OTC, Radio-pharmaceutical, Pharmacies and Medical Device Industries in understanding the effective way to establish a new or modified product stability testing program. This program is an important part of a product's regulatory filing requirements as well as the determination of the shelf life or expiration date of the product
Kontakt:
Tel.: [+1-888-717-2436];     Email: referral@complianceonline.com
Themen:
fda drug stability testing program, drug product stability testing, ich drug product stability, product stability test, fda drug product stability guidance, stability studies, analyzing stability data, stability protocols and schedules
Eintrags-ID:
1409969
Verwandte Fachgebiete:
4
Risk Management in Medical Devices Industry
03. Mär 2021 - 04. Mär 2021 • SanJose – online, 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 harm to patients, users, and the environment.
Kontakt:
Tel.: [+1-888-717-2436];     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:
1409946
Verwandte Fachgebiete:
5
Care Coordination: A Fundamental Role for Managing Cost and Length of Stay
08. Mär 2021 • SanJose – online, Vereinigte Staaten
Veranstalter:
Complianceonline
Zusammenfassung:
In this care coordination training you will learn how to apply the key strategies for reducing your hospital’s cost and length of stay. Also you will learn how to appreciate the role of interdisciplinary care rounds by identifying your hospital’s strength and weakness related to care coordination.
Kontakt:
Tel.: [+1-888-717-2436];     Email: referral@complianceonline.com
Themen:
care coordination in healthcare, care coordination in hospital, care coordination in nursing, care coordination strategies, care coordination training, care coordination program
Eintrags-ID:
1409821
Verwandte Fachgebiete:
6
Medical Device Complaints & CAPA
09. Mär 2021 • Fremont – online, Vereinigte Staaten
Veranstalter:
Panelcompliance
Kontakt:
Event Manager;     Tel.: [1-800-447-9407];     Email: panelcompliance@gmail.com
Themen:
Healthcare, Healthcare Education, Covid, Coronavirus, Education
Eintrags-ID:
1410658
Verwandte Fachgebiete:
7
Marketing to Medicare or Medicaid Beneficiaries - What You Can and Cannot Do
10. Mär 2021 • SanJose – online, Vereinigte Staaten
Veranstalter:
Complianceonline
Zusammenfassung:
This webinar will review not only the Anti-Kickback Statute and its safe harbors, but will provide an in-depth overview of OIG guidance and advisory opinions dealing with marketing activities, as well as a review of case law regarding marketing behavior.
Kontakt:
Tel.: [+1-888-717-2436];     Email: referral@complianceonline.com
Themen:
Anti-Kickback, Medicare, Medicaid, OIG advisory, OIG compliance, OIG, DME provider, Civil Monetary Penalties, hospital, physician practice
Eintrags-ID:
1409875
Verwandte Fachgebiete:
8
How to Prepare a Standard Operating Procedure (SOP)?
10. Mär 2021 • SanJose – online, Vereinigte Staaten
Veranstalter:
Complianceonline
Zusammenfassung:
This webinar will detail a step-by-step procedure on how to write a practical, effective and compliant Standard Operating Procedures (SOPs), review and revise SOPs and maintain compliance over the course of the SOP life-time.
Kontakt:
Tel.: [+1-888-717-2436];     Email: referral@complianceonline.com
Themen:
sop, sop training, standard operating procedure
Eintrags-ID:
1409830
Verwandte Fachgebiete:
9
6-Hour Virtual Seminar on The New EU Medical Device Regulation
10. Mär 2021 • Fremont – online, Vereinigte Staaten
Veranstalter:
Vctrainings
Kontakt:
Event Manager;     Tel.: [1-800-447-9407];     Email: vctrainings2020@gmail.com
Themen:
Healthcare, Healthcare Education, Covid, Coronavirus, Education
Eintrags-ID:
1410622
Verwandte Fachgebiete:
10
Lifecycle Management of Analytical Methods and Procedures according to new USP and ICH Guidelines
11. Mär 2021 • SanJose – online, Vereinigte Staaten
Veranstalter:
Complianceonline
Zusammenfassung:
Managing analytical methods and procedures according to the lifecycle approach has been recommended in recent FDA guidance documents and stimuli articles published by the USP. For example, the recent FDA guidance “Analytical Procedures and Methods Validation for Drugs and Biologics” contains a section on Lifecycle Management of Analytical Procedures.
Kontakt:
Tel.: [+1-888-717-2436];     Email: referral@complianceonline.com
Themen:
Analytical Instrument Qualification, USP General Chapter 1058, instrument qualification lifecycle, analytical method lifecycle management, analytical lifecycle management presentation, analytical life cycle, model lifecycle management, usp analytical method
Eintrags-ID:
1409901
Verwandte Fachgebiete:
11
Navigating through Maze of In-vitro Diagnostics (IVD) Regulations: A systematic approach from Regulatory Strategy to Regulatory Approvals in U.S./Europe/Canada
11. Mär 2021 - 12. Mär 2021 • SanJose – online, 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.: [+1-888-717-2436];     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:
1409933
Verwandte Fachgebiete:
12
Implementing a Robust Data Integrity Program
12. Mär 2021 • SanJose – online, Vereinigte Staaten
Veranstalter:
Complianceonline
Zusammenfassung:
This webinar will detail a data integrity governance program and principles for defining quality and data integrity into processes and systems. It will cover the common problems from FDA 483 observations and warning letters and teach you how to avoid them.
Kontakt:
Tel.: [+1-888-717-2436];     Email: referral@complianceonline.com
Themen:
Fda data integrity guidance final, data integrity and compliance, fda data integrity audit, FDA (CFR) data integrity guidance, EurdraLex data integrity guidance review, PIC/S data integrity guidance, Protecting electronic records of standalone systems, Audit trail, data integrity access control, data integrity program, data integrity definition
Eintrags-ID:
1409840
Verwandte Fachgebiete:
13
Validation Essentials for Medical Device Manufacturers - IQ, OQ, PQ
16. Mär 2021 • SanJose – online, Vereinigte Staaten
Veranstalter:
Complianceonline
Zusammenfassung:
This course will cover validation essentials for medical device manufacturers. Attendees will learn about what processes needed to be validated and what steps you need to take to validate processes. You’ll learn the essentials of validation planning, protocol writing, and change management. We’ll cover the steps of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) including tips and best practices.
Kontakt:
Tel.: [+1-888-717-2436];     Email: referral@complianceonline.com
Themen:
validation of medical devices, medical device process validation, medical device validation protocol, quality system regulations, iso 13485, iq oq pq medical devices
Eintrags-ID:
1409949
Verwandte Fachgebiete:
14
The EU Medical Device Regulation (MDR 745/2017) - The New Process to Enter the European Market
25. Mär 2021 • Fremont – online, Vereinigte Staaten
Veranstalter:
Panelcompliance
Kontakt:
Event Manager;     Tel.: [1-800-447-9407];     Email: panelcompliance@gmail.com
Themen:
Healthcare, Healthcare Education, Covid, Coronavirus, Education
Eintrags-ID:
1410602
Verwandte Fachgebiete:


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Stand vom 23. Februar 2021