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

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Belgium (2) - Germany (6) - India (3) - Switzerland (1) - United Kingdom (3) - United States (24) - ALL COUNTRIES (39)

1
Underutilized and Underappreciated in Management Control
21 Feb 2018 • Fremont, United States
Abstract:
Management with executive responsibility is responsible for establishing a quality policy and objectives and for demonstrating a commitment to quality. And management at all levels should be aware of and engaged in quality efforts and customer focus.
Contact:
Event Manager;     Phone: [18004479407];     Email: support@compliance4All.com
Topics:
medical trainings, Compliance trainings, healthcare trainings, Online trainings
Event listing ID:
979024
2
Learn Some of the Acceptance Activities in FDA QSR
21 Feb 2018 • Fremont, United States
Abstract:
As you ensure that your Quality Management System meets FDA's regulations, you need robust acceptance activities. A gap could result in a Warning Letter, but even worse, it could also create a recall. This presentation provides the implementation information as well as the audit strategy to help verify your processes.
Contact:
Event Manager;     Phone: [18004479407];     Email: support@compliance4All.com
Topics:
medical trainings, Compliance trainings, healthcare trainings, Online trainings
Event listing ID:
979089
3
Workshop — 2 Day Workshop: Preparing For The New EU Medical Device Regulations (MDR)
21 Feb 2018 - 22 Feb 2018 • Hollywood, United States
Contact:
Conference Manager;     Phone: [347 282-5400];     Email: support@worldcomplianceseminars.in
Event listing ID:
974086
4
Workshop — 2 Days Workshop: Preparing For The New EU Medical Device Regulations (MDR)
21 Feb 2018 - 22 Feb 2018 • Burlingame, CA, United States
Abstract:
The new Medical Device Regulations (MDR) were published in the Official Journal of the European Union on May 5, 2017. From that date, manufacturers, suppliers, Notified Bodies, and national competent authorities have a transition period of three years to comply with the new set of rules. Given the large scale of changes, there is great pressure on all actors to analyze the MDR, conduct impact assessments, and implement compliant processes. After May 2020, non-compliance threatens CE-mark certification, access to the European market, or, in the case of Notified Bodies, re-designation.
Contact:
Conference Manager;     Phone: [347 282-5400];     Email: support@worldcomplianceseminars.com
Event listing ID:
1006731
5
NDAs and INDs for Orally-Administered Drug Products
28 Feb 2018 • Fremont, United States
Contact:
Event Manager;     Phone: [18004479407];     Email: support@compliance4All.com
Topics:
medical trainings, Compliance trainings, healthcare trainings, Online trainings
Event listing ID:
979044
6
How Ensuring Data Integrity in Method Validations
28 Feb 2018 • Fremont, United States
Abstract:
This section plays a major role in both purchasing and in production. It is a major contributor to determine whether your supplier and manufacturing process are working effectively.
Contact:
Event Manager;     Phone: [18004479407];     Email: support@compliance4All.com
Topics:
medical trainings, Compliance trainings, healthcare trainings, Online trainings
Event listing ID:
979054
7
A Legal Compliance Program When Billing Durable Medical Equipment
01 Mar 2018 • Aurora, United States
Abstract:
Learn that treating your Medicare patients with Durable Medical Equipment can be great for patient clinical outcomes, a great revenue stream and can be legally compliant. It will also lower healthcare costs. However one must know how to get the proper licensure and know the Federal & State Guidelines.
Contact:
Training Doyens;     Phone: [7209961616];     Email: support@trainingdoyens.com
Topics:
medical device training programs, medical equipment repair course, medical equipment repair training, medical equipment training
Event listing ID:
1015090
Event website:
8
CfPIE - The Center for Professional Innovation & Education — Product Quality Reviews
01 Mar 2018 - 03 Mar 2018 • Los Angeles, CA, United States
Abstract:
The purpose of the course is to educate the participant in the regulatory requirements for the Annual Product Review while demonstrating the power of the Periodic or Annual Product Review as a Quality Assurance and Quality Improvement tool. We will discuss how the Product Review supports the US, EU and Canadian GMPS while applying the ICH Q10, Pharmaceutical Quality System elements of Process Performance and Product Quality Monitoring, CAPA, Change Management and Management Review, as well as the enablers of Information Management and Risk Management. Discussion will also include the impact of the FDA 2011 Process Validation guidance and the potential impact of the proposed FDA requirement for Quality Metrics on the Product Review.
Contact:
Registration Department;     Phone: [1-610-648-7550];     Email: info@cfpie.com
Topics:
The regulatory requirements for the Annual Product Review The Annual Product Review as it relates to other required and expected reports The Annual Product Review as part of a contemporary Quality System What should be included in the Product Review The Product Review as a source of recommendations for process improvement Management involvement and responsibility The Product Review in support of stage 3 of process validation, continued process verification The Product Review process as a user of, and contributor to, the corporate knowledge The application of quality metrics to the Product Review process
Event listing ID:
1006888
9
Course - The Center for Professional Innovation & Education — Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products
05 Mar 2018 - 06 Mar 2018 • Boston, MA, United States
Abstract:
Whether for biopharmaceutical or pharmaceutical applications, this course presents the technical basics that govern aseptic processing and provides practical advice for attendees to troubleshoot and manage their aseptic operations. Attendees from the sterile medical device industry have also benefited from this training.
Contact:
Olivia Carlin;     Phone: [1-610-648-7550];     Email: info@cfpie.com
Topics:
Risk Management, Containers, Package Integrity, Depyrogenation, Lyophilization, Media Fills
Event listing ID:
1013556
10
Workshop — 2 Day Workshop: FDA Inspections: What Regulators Expect and How to Prepare
14 Mar 2018 - 15 Mar 2018 • San Diego, United States
Contact:
Conference Manager;     Phone: [347 282-5400];     Email: support@worldcomplianceseminars.in
Event listing ID:
974030
11
Workshop — 2 Day Workshop: FDA Inspections: What Regulators Expect and How to Prepare
14 Mar 2018 - 15 Mar 2018 • San Diego CA, United States
Abstract:
This is a practical, hands-on course designed to provide pharmaceutical, biopharmaceutical, biologics and medical device professionals with the information and tools they require to prepare for and manage an FDA inspection efficiently, effectively and successfully. Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions.
Contact:
Conference Manager;     Phone: [347 282-5400];     Email: support@worldcomplianceseminars.com
Event listing ID:
1006767
12
Workshop — 2 Day Workshop: Human Error: Why Human Error is the biggest downtime problem in the manufacturing sector and how to investigate, control, reduce, and prevent to improve results.
15 Mar 2018 - 16 Mar 2018 • Hollywood, United States
Contact:
Conference Manager;     Phone: [347 282-5400];     Email: support@worldcomplianceseminars.in
Event listing ID:
974073
13
Workshop — 2 Day Workshop: Human Error: Why Human Error is the biggest downtime problem in the manufacturing sector and how to investigate, control, reduce, and prevent to improve results.
15 Mar 2018 - 16 Mar 2018 • New Brunswick, United States
Abstract:
Small mistakes can lead to big disasters—just ask the scientists and engineers who worked on the Mars Climate Orbiter: a $327.6-million USD spacecraft that was destroyed because of a failure to properly convert between units of measurement.Any manufacturer who’s had to shut down an entire production line because someone misread a label or forgot to “carry the one” can sympathize. In fact, according to a new study from Vanson Bourne, manufacturers know the pain of unplanned downtime due to human error better than anyone.
Contact:
Conference Manager;     Phone: [347 282-5400];     Email: support@worldcomplianceseminars.com
Event listing ID:
1006747
14
Workshop — 1 Day workshop GMP’s in practice: quality systems, common sense compliance, and application
22 Mar 2018 • Washington D.C, United States
Abstract:
This course covers all GMP 211 sub-parts including Part 11 and electronic batch records. Also, this course covers more than 30 elements of a modern quality system, it’s requirements, expectations, and examples. Each element is explored with applicable regulation from US FDA, Health Canada, European Union WHO and ICH (for multinationals).
Contact:
Conference Manager;     Phone: [347 282-5400];     Email: support@worldcomplianceseminars.com
Event listing ID:
1002981
15
Workshop — 1 Day workshop GMP’s in practice: quality systems, common sense compliance, and application
22 Mar 2018 • Washington D.C, United States
Abstract:
Course"GMP’s in practice: quality systems, common sense compliance, and application" has been pre-approved by RAPS as eligible for up to 6 credits towards a participant’s RAC recertification upon full completion This course covers all GMP 211 sub-parts including Part 11 and electronic batch records. Also, this course covers more than 30 elements of a modern quality system, it’s requirements, expectations, and examples. Each element is explored with applicable regulation from US FDA, Health Canada, European Union WHO and ICH (for multinationals).
Contact:
Conference Manager;     Phone: [347 282-5400];     Email: support@worldcomplianceseminars.com
Event listing ID:
1006744
16
2nd Interim Analysis Symposium (EXL)A
26 Mar 2018 - 27 Mar 2018 • Philadelphia, PA, United States
Abstract:
The 2nd Interim Analysis Symposium will provide drug safety and clinical operations teams with best practices and tried-and-true strategies that will enhance the capacity at which organizations can produce upstanding reports about the results of their ongoing studies and expedite effective products to market.
Event listing ID:
957005
17
2nd Product Complaints Forum (EXL)A
26 Mar 2018 - 27 Mar 2018 • Philadelphia, PA, United States
Abstract:
ExL Events’ 2nd Product Complaints Forum will provide insight into how to improve the management of product complaints and potential recalls. This program will feature case studies, panel sessions, and two tracks designed to deliver information for pharmaceutical, biotechnology, and medical device professionals involved in all stages of handling product complaints and potential recalls.
Event listing ID:
956971
18
Workshop — 2 Day Workshop Product Registration and Navigating the Approval Process with Regulatory Authorities in Asia Pacific, Europe, Middle East and The Americas
25 Apr 2018 • Boston, United States
Contact:
Conference Manager;     Phone: [347 282-5400];     Email: support@worldcomplianceseminars.in
Event listing ID:
974138
19
Workshop — 2 Day Workshop Product Registration and Navigating the Approval Process with Regulatory Authorities in Asia Pacific, Europe, Middle East and The Americas
25 Apr 2018 - 26 Apr 2018 • Boston,MA, United States
Abstract:
Description

One of the first steps towards selling a Class II medical device or IVD in the United States is to file a Premarket Notification with the FDA, also known as an FDA 510(k) submission. Technically, the FDA does not "approve" medical devices or IVDs for sale under the 510(k) process; the agency gives "clearance" for them to be sold in the U.S. We use the term "FDA approval" for simplicity. Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.

Contact:
Conference Manager;     Phone: [347 282-5400];     Email: support@worldcomplianceseminars.com
Event listing ID:
1003056
20
Workshop — Current issues in assuring data integrity in life sciences : 2 Days Seminar
25 Apr 2018 - 26 Apr 2018 • San Diego CA, United States
Abstract:
Data Integrity is a major concern of regulatory agencies worldwide as evidenced by the increasing number of Warning Letters issued in that area. Some managements have proceeded to implement data integrity programs on the lines of those implemented in “big data”. This has resulted in the escalation of costs and it is disproportionate to the benefits gained. Some even wonder why they continue to receive Warning Letters in spite of spending the dollars to implement programs such as Data Governance etc. etc.
Contact:
Conference Manager;     Phone: [347 282-5400];     Email: support@worldcomplianceseminars.com
Event listing ID:
1006748
21
Workshop — 2 Day Workshop Product Registration and Navigating the Approval Process with Regulatory Authorities in Asia Pacific, Europe, Middle East and The Americas
25 Apr 2018 - 26 Apr 2018 • Boston,MA, United States
Abstract:
One of the first steps towards selling a Class II medical device or IVD in the United States is to file a Premarket Notification with the FDA, also known as an FDA 510(k) submission. Technically, the FDA does not "approve" medical devices or IVDs for sale under the 510(k) process; the agency gives "clearance" for them to be sold in the U.S. We use the term "FDA approval" for simplicity. Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.
Contact:
Conference Manager;     Phone: [347 282-5400];     Email: support@worldcomplianceseminars.com
Event listing ID:
1006779
22
4th Annual ComplianceOnline Medical Device Summit 2018
07 Jun 2018 - 08 Jun 2018 • San Francisco, United States
Abstract:
Plan for successfully executing regulatory inspections by providing industry best practices. Panel discussions led by the former FDA office bearers and industry experts will provide a set of comprehensive strategies on how to prepare for and manage an FDA inspection, including how to follow-up and closing out 483s or Warning Letters. Attending this summit will enable you to improve and better prepare for your next inspections.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Event listing ID:
954507
23
Gordon Research Seminar — Drug Safety
09 Jun 2018 - 10 Jun 2018 • Stonehill College, Easton, MA, United States
Topics:
Drug Safety in the Modern Development Landscape: Innovations from Industry, Academia, and Government
Event listing ID:
960088
24
Gordon Research Conference — Drug Safety
10 Jun 2018 - 15 Jun 2018 • Stonehill College, Easton, MA, United States
Topics:
Contemporary Advances and Challenges in Drug Safety Assessment
Event listing ID:
960056

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AIP Conference Proceedings
AIP Conference Proceedings
Last updated: 12 February 2018