Meetings/Workshops on Regulation in Medicine and Pharmacology in the United States (USA)

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1
Managing GMP Compliance and Phase Appropriate GMP Considerations for Virtual Companies
01 Mar 2021 - 02 Mar 2021 • SanJose – online, United States
Organizer:
Complianceonline
Abstract:
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.)
Contact:
Phone: [+1-888-717-2436];     Email: referral@complianceonline.com
Topics:
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
Event listing ID:
1409926
Related subject(s):
2
Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance
03 Mar 2021 • SanJose – online, United States
Organizer:
Complianceonline
Abstract:
Learn how to use Microsoft Excel spreadsheets for GXP data to ensure compliance with 21 CFR Part 11 and reduce validation cost and time.
Contact:
Phone: [+1-888-717-2436];     Email: referral@complianceonline.com
Topics:
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
Event listing ID:
1409822
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3
Designing and Sustaining New and Existing Product Stability Testing Program
03 Mar 2021 - 04 Mar 2021 • SanJose – online, United States
Organizer:
Complianceonline
Abstract:
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
Contact:
Phone: [+1-888-717-2436];     Email: referral@complianceonline.com
Topics:
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
Event listing ID:
1409969
Related subject(s):
4
Risk Management in Medical Devices Industry
03 Mar 2021 - 04 Mar 2021 • SanJose – online, United States
Organizer:
Complianceonline
Abstract:
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.
Contact:
Phone: [+1-888-717-2436];     Email: referral@complianceonline.com
Topics:
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
Event listing ID:
1409946
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5
Care Coordination: A Fundamental Role for Managing Cost and Length of Stay
08 Mar 2021 • SanJose – online, United States
Organizer:
Complianceonline
Abstract:
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.
Contact:
Phone: [+1-888-717-2436];     Email: referral@complianceonline.com
Topics:
care coordination in healthcare, care coordination in hospital, care coordination in nursing, care coordination strategies, care coordination training, care coordination program
Event listing ID:
1409821
Related subject(s):
6
Medical Device Complaints & CAPA
09 Mar 2021 • Fremont – online, United States
Organizer:
Panelcompliance
Contact:
Event Manager;     Phone: [1-800-447-9407];     Email: panelcompliance@gmail.com
Topics:
Healthcare, Healthcare Education, Covid, Coronavirus, Education
Event listing ID:
1410658
7
Marketing to Medicare or Medicaid Beneficiaries - What You Can and Cannot Do
10 Mar 2021 • SanJose – online, United States
Organizer:
Complianceonline
Abstract:
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.
Contact:
Phone: [+1-888-717-2436];     Email: referral@complianceonline.com
Topics:
Anti-Kickback, Medicare, Medicaid, OIG advisory, OIG compliance, OIG, DME provider, Civil Monetary Penalties, hospital, physician practice
Event listing ID:
1409875
Related subject(s):
8
How to Prepare a Standard Operating Procedure (SOP)?
10 Mar 2021 • SanJose – online, United States
Organizer:
Complianceonline
Abstract:
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.
Contact:
Phone: [+1-888-717-2436];     Email: referral@complianceonline.com
Topics:
sop, sop training, standard operating procedure
Event listing ID:
1409830
Related subject(s):
9
6-Hour Virtual Seminar on The New EU Medical Device Regulation
10 Mar 2021 • Fremont – online, United States
Organizer:
Vctrainings
Contact:
Event Manager;     Phone: [1-800-447-9407];     Email: vctrainings2020@gmail.com
Topics:
Healthcare, Healthcare Education, Covid, Coronavirus, Education
Event listing ID:
1410622
10
Lifecycle Management of Analytical Methods and Procedures according to new USP and ICH Guidelines
11 Mar 2021 • SanJose – online, United States
Organizer:
Complianceonline
Abstract:
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.
Contact:
Phone: [+1-888-717-2436];     Email: referral@complianceonline.com
Topics:
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
Event listing ID:
1409901
Related subject(s):
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 Mar 2021 - 12 Mar 2021 • SanJose – online, United States
Organizer:
Complianceonline
Abstract:
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:
Phone: [+1-888-717-2436];     Email: referral@complianceonline.com
Topics:
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
Event listing ID:
1409933
Related subject(s):
12
Implementing a Robust Data Integrity Program
12 Mar 2021 • SanJose – online, United States
Organizer:
Complianceonline
Abstract:
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.
Contact:
Phone: [+1-888-717-2436];     Email: referral@complianceonline.com
Topics:
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
Event listing ID:
1409840
Related subject(s):
13
Validation Essentials for Medical Device Manufacturers - IQ, OQ, PQ
16 Mar 2021 • SanJose – online, United States
Organizer:
Complianceonline
Abstract:
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.
Contact:
Phone: [+1-888-717-2436];     Email: referral@complianceonline.com
Topics:
validation of medical devices, medical device process validation, medical device validation protocol, quality system regulations, iso 13485, iq oq pq medical devices
Event listing ID:
1409949
Related subject(s):
14
The EU Medical Device Regulation (MDR 745/2017) - The New Process to Enter the European Market
25 Mar 2021 • Fremont – online, United States
Organizer:
Panelcompliance
Contact:
Event Manager;     Phone: [1-800-447-9407];     Email: panelcompliance@gmail.com
Topics:
Healthcare, Healthcare Education, Covid, Coronavirus, Education
Event listing ID:
1410602


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Last updated: 23 February 2021