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

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1
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:
1409832
Related subject(s):
2
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:
1410570
3
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:
1409820
Related subject(s):
4
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:
1409896
Related subject(s):
5
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:
1410600
6
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:
1409923
Related subject(s):
7
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:
1409999
Related subject(s):
8
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:
1409939
Related subject(s):
9
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:
1409883
Related subject(s):
10
Implementing UDI (Unique Device Identification) - Plan Now for Success
16 Mar 2021 • SanJose, United States
Organizer:
Complianceonline
Abstract:
The one-day virtual seminar provides the information you need to implement UDI. An effective implementation gives your customers the information they need. It will also help you avoid an FDA 483 and a Warning Letter.

The virtual seminar gives you hands on experience to understand UDI and your device. You bring a laptop computer and some information about your device. During the seminar you receive toolkits to determine the compliance dates, packaging configurations, and the attributes you will load to GUDID

Contact:
Phone: [+1-888-717-2436];     Email: referral@complianceonline.com
Topics:
UDI Implementation Course, Unique Device Identification, GUDID, label, package, compliance dates, direct marketing, QMS, record retention, FDA inspection, 510k, eMDR, UDI rule (Parts 801, 803, 806, 814, 820, 821, 822, and 830), CDRH guidance documents
Event listing ID:
1411855
11
Ensuring Compliance with Advertising and Promotional Requirements for Drugs and Medical Devices
18 Mar 2021 - 19 Mar 2021 • SanJose, United States
Organizer:
Complianceonline
Abstract:
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.
Contact:
Phone: [+1-888-717-2436];     Email: referral@complianceonline.com
Topics:
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
Event listing ID:
1411832
12
PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation
18 Mar 2021 - 19 Mar 2021 • SanJose, United States
Organizer:
Complianceonline
Abstract:
In this two day workshop conference we will review the EMA and FDA requirements regarding Risk Based Audits of the PV system and Quality System. The course will focus on the design of the PV audit strategy, identification of the PV processes and entities subject to PV audit (define the PV audit universe), development of risk assessment methodology, development of procedures/tools to monitor PV processes and activities, and implementation of the PV audit strategy plan. Additionally, we will review methods of quality oversight and management of third parties performing PV activities.
Contact:
Phone: [+1-888-717-2436];     Email: referral@complianceonline.com
Topics:
pharmacovigilance audit strategy planning, good pharmacovigilance practices, pv audit strategy plan, risk based pharmacovigilance audits, pharmacovigilance audit plan, fda pharmacovigilance audits, pharmacovigilance audit checklist, pharmacovigilance auditing training, fda pharmacovigilance inspections
Event listing ID:
1411875
Related subject(s):
13
Medical Device Cybersecurity Risk Management Training
22 Mar 2021 • SanJose, United States
Organizer:
Complianceonline
Abstract:
This webinar will give you a clear structured overview and introduction, into the cybersecurity risk management in relation to the cybersecurity regulation in EU and US and its requirements in the EU and US.
Contact:
Phone: [+1-888-717-2436];     Email: referral@complianceonline.com
Topics:
cybersecurity for medical devices, medical device cybersecurity standards, medical device cybersecurity fda, medical device cybersecurity risk assessment, medical device cybersecurity, risk management and cybersecurity, cybersecurity risk management program, cybersecurity risk management process, medical device cybersecurity training, cybersecurity risk management tools
Event listing ID:
1411802
14
Global Regulations for Equipment Qualification and Validation of Processes in the Pharma Manufacturing
24 Mar 2021 - 25 Mar 2021 • SanJose, United States
Organizer:
Complianceonline
Abstract:
The various regulatory agencies have expectations that pharmaceutical manufacturers will demonstrate control over their manufacturing equipment. The FDA's findings of deficiencies concerning equipment validation indicate the agencies expect definitive evidence that the equipment qualification and validation schedules of a facility will satisfactorily control their manufacturing processes. Examples of FDA form 483 findings for equipment qualification and validation indicate deficiencies in many of these studies.
Contact:
Phone: [+1-888-717-2436];     Email: referral@complianceonline.com
Topics:
Equipment Qualification, DQ, IQ, OQ, PQ, Validation Processes, Change Control, Validation Master Plan (VMP), SOPs, QMS, Risk Analysis, FDA Warning Letters, case Study, FDA Compliance Seminar
Event listing ID:
1411830
Related subject(s):
15
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
16
Implementing the 2021 Guidelines for Office and Outpatient Visits
25 Mar 2021 • SanJose, United States
Organizer:
Complianceonline
Abstract:
The current guidelines for documentation of office and outpatient visits were implemented in the early 90’s and have become cumbersome and outdated for the current medical provider. For 2021 CMS and the AMA have joined together to create and implement new documentation guidelines for office and outpatient visits that must be used starting January 1, 2021.
Contact:
Phone: [+1-888-717-2436];     Email: referral@complianceonline.com
Topics:
ama cpt guidelines 2021, 2021 icd 10 update, new icd 10 codes 2021, em guidelines 2020, cpt changes for 2021, 2021 cpt coding changes, 2021 e&m guidelines, cms 2021 e m guidelines
Event listing ID:
1411867
17
Quality and GMP Compliance for Virtual Companies (Pharmaceutical and Biologics Industries)
29 Mar 2021 - 30 Mar 2021 • SanJose, United States
Organizer:
Complianceonline
Abstract:
In this two day workshop conference you will learn the requirements and expectations of major health care regulators that are applicable to "virtual" companies. You will learn how to diagnose your company's needs based on which GMP and GCP-governed operations you retain and which you outsource; what the current expectations and best industry practices are for selecting, qualifying and monitoring your contractors to ensure they are meeting your requirements; and how to build a quality system framework that is not excessive for your current needs, but has the structure and integration to "grow with you" as the scope your operations change in the coming months and years.
Contact:
Phone: [+1-888-717-2436];     Email: referral@complianceonline.com
Topics:
GMP compliance for virtual companies, contract manufacturing organizations (CMOs), contract research organizations (CROs), Contract Laboratories, quality agreement, technical agreement, good clinical practice (GCP), FDA inspection for virtual companies
Event listing ID:
1411895
18
CDD — CHI's Drug-Diagnostics Co-Development
24 Aug 2021 - 25 Aug 2021 • Washington, DC, United States
Organizer:
Cambridge Healthtech Institute (CHI)
Abstract:
This conference is designed to facilitate knowledge and opinion exchange between pharmaceutical and diagnostics executives, translational scientists, clinicians, business experts, regulators, international companion diagnostics leaders, and other parties involved in drug-diagnostics co-development and precision medicine. Case studies of successful collaboration between pharmaceutical and diagnostics companies will be presented. This conference is part of the Next Generation Dx Summit.
Contact:
Phone: [781-972-5400];     Email: reg@healthtech.com
Topics:
drug, diagnostics, drug-diagnostics, medicare, drug reimbursement, diagnostic reimbursement, technology, technologies, lab tests, pharmaceuticals, biomarkers, immuno-oncology, precision medicine
Event listing ID:
1411686
Related subject(s):
19
IDX — CHI's Advanced Diagnostics for Infectious Disease
25 Aug 2021 - 26 Aug 2021 • Washington, DC, United States
Organizer:
Cambridge Healthtech Institute (CHI)
Abstract:
At this conference, leaders working in the clinical lab, research, biotech, and pharma will come together to showcase the latest in diagnostic technology and find solutions for the biggest challenges facing the clinical lab, including managing workflow, incorporating NGS and molecular testing, gaining reimbursement and regulatory approval, and more. This conference is part of the Next Generation Dx Summit.
Contact:
Phone: [781-972-500];     Email: reg@healthtech.com
Topics:
diagnostics, advanced diagnostics, infectious diseases, infectious disease testing, molecular diagnostic test, MDx test, COVID-19, CRISPR, pandemics, POCT
Event listing ID:
1411673
Related subject(s):


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Last updated: 03 March 2021