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

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1
Medical Devices: EU Directives, CE marking, ISO Certification and the NEW Device Regulations coming to the EU
08 Dec 2020 • SanJose – online, United States
Organizer:
Complianceonline
Abstract:
This Medical device training will be discussing the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products.
Contact:
Phone: [+1-888-717-2436];     Email: referral@complianceonline.com
Topics:
Compliance Training on Medical Device Directives, Directives for Medical Devices, Training for Medical Device Compliance, EU Clinical Trial Directive Compliance Webinar, EUCTD Compliance, CE Marking for Medical Devices, Requirements for CE Marks, ISO Certification Compliance for Medical Devices, Medical Device regulations, regulatory compliance for medical devices, CE Mark compliance training, ISO certification compliance webinar, online training for CE marking and medical devices, CE, ISO, Medical Devices, EU MDD Compliance Online Training, EU, MDD, Medical Device Packaging and Labeling Compliance, Regulatory Compliance for EUCTD, EU legislation for medical devices, EU rules for medical devices, EU regulations
Event listing ID:
1391261
2
Medical Device Cybersecurity and FDA Compliance
10 Dec 2020 • SanJose – online, United States
Organizer:
Complianceonline
Abstract:
In this webinar, you will learn just how cyberattacks threaten medical devices and how industry is currently responding to them. We will discuss the many ways of preventing and mitigating the cybersecurity risk, and about the industry best practices that can help your company do the same.
Contact:
Phone: [+1-888-717-2436];     Email: referral@complianceonline.com
Topics:
Medical Device Safety, medical device cybersecurity issues, medical device cybersecurity standards, fda cybersecurity guidance, cybersecurity for networked medical devices, medical device cybersecurity training, medical cybersecurity, Malware and Virus Software, Good System Development Practices, Good Documentation Practices (GDPs), Computer System Validation (CSV), System Development Life Cycle (SDLC) Methodology, Risk Assessment and Mitigation, Computer System Validation Plan, GAMP 5 System Classification, Functional Requirements Specification (FRS), System Design Specification (SDS), Configuration Management Plan, 21 CFR Part 11 (Electronic Records/Electronic Signatures), Computer System Testing, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), User Acceptance Testing (UAT), Test Summary Report, System Acceptance Report, System Release Notification, Validation Summary Report, Policies and Procedures, Training Materials and Documentation, Organizational Change Management (OCM), Business Process Re-engineering (BPR), Disaster Recovery (DR) Planning, Business Continuity Planning (BCP), Periodic System Review, Change Control, Audit Trails, Computer System Security, Integration of Validated Systems
Event listing ID:
1385867
Related subject(s):
3
Fair Hearings from A Hearing Officer's Perspective
10 Dec 2020 • SanJose – online, United States
Organizer:
Complianceonline
Abstract:
This training will prepare hearing officer for corrective actions and how to prepare for the hearing. It will cover application process for new applicants which include prior practice, references, prior adverse actions and liability settlements. Attendees will learn elements of good, clear and concise bylaws, fair hearing plans and other policies.
Contact:
Phone: [+1-888-717-2436];     Email: referral@complianceonline.com
Topics:
Medical Staff Litigation, Fair Hearing Policy, Medical Staff Adverse Action Hearings, corrective action, fair hearing plan, hearing process for adverse actions, adverse peer review action, Medical Staff Bylaws
Event listing ID:
1391293
4
FDA's Ambitious Regulation of Social Media
10 Dec 2020 • SanJose – online, United States
Organizer:
Complianceonline
Abstract:
FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person’s behavior and decision outcomes. How FDA applies its legal tenants of false and misleading information or variations on that theme requires continual updating by FDA and constant re-evaluation by industry. Now the regulatory landscape involves other federal agencies and academic principles in psychology. It has become very complicated and will prove very costly if you knowingly or unknowing walk into one of FDA’s legal snares. This webinar will bring attendees up to speed so you are clearer about what is a problem, what is not a problem and what becomes a risk laden judgment call.
Contact:
Phone: [+1-888-717-2436];     Email: referral@complianceonline.com
Topics:
FDA advertising and promotion, FDA labeling, fair and balanced information considerations, context of messaging and target population, exemptions for social media use
Event listing ID:
1391303
5
Quality and GMP Compliance for Virtual Companies (Pharmaceutical and Biologics Industries)
10 Dec 2020 - 11 Dec 2020 • SanJose, United States
Organizer:
Complianceonline
Abstract:
Today, many companies operate on an outsourcing model. This is very common for companies who are evolving from being mainly development-focused to a point where they are entering latter stages of Phase 2 or Phase 3 clinical trials, and plan to have a product ready for market approval in the coming months. Most such companies are small, and may not have deep expertise in QA and GMP compliance, relying on their partners to cover those areas. Companies who outsource the majority of operations through the use of Contract Manufacturing Organizations (CMOs), Contract Research Organizations (CROs) and Contract Laboratories, however, remain responsible for the quality and compliance status of the products they send to the clinic or to the marketplace.
Contact:
Phone: [+1-888-717-2436];     Email: referral@complianceonline.com
Topics:
gmp compliance for virtual companies, gmp compliance training, statement of gmp compliance, gmp compliance audit checklist, cgmp compliance requirements, fda gmp guidelines, gmp good manufacturing practices guidelines, pharmaceutical gmp compliance
Event listing ID:
1391311
6
Post Market Surveillance with the new Medical Device Regulation EU MDR 745/2017
14 Dec 2020 • SanJose – online, United States
Organizer:
Complianceonline
Abstract:
This webinar will help you understand the requirements of the new medical device regulation EU MDR 745/2017 and teach you how to create the reports. The understanding of the changes and how to implement last-minute changes until May 2020 is essential to keep your certificates and to sell your products after May 2020 to the European Union.
Contact:
Phone: [+1-888-717-2436];     Email: referral@complianceonline.com
Topics:
EU MDR 745/2017, Post Market Surveillance Activities, quality management system, Post Market Surveillance according to EU MDR 745/2017
Event listing ID:
1391346
7
Lead Auditor EN ISO 13485:2016 and EU MDR 2017/745 - Regulation
15 Dec 2020 - 16 Dec 2020 • SanJose, United States
Organizer:
Complianceonline
Abstract:
The new medical device regulation EU MDR 745/2017 in the European Union has a lot of new requirements. This new upcoming regulation is also stronger connected to the EN ISO 13485:2016. The understanding of this changes and how to implement last minute changes until May 2021 is essential to keep your certificates. The first key for the understanding and the implementation of the changes is the knowledge about the interfaces between the EN ISO 13485:2016 and the EU MDR 2017/745. The second key is to understand, which parts of the EU MDR 2017/745 are not covered by the EN ISO 13485:2016. These not covered paragraphs and requirements must be additional implemented into the quality management system until May 2020. The time is short and immediately action is required.
Contact:
Phone: [+1-888-717-2436];     Email: referral@complianceonline.com
Topics:
EU MDR 745/2017, EN ISO 13485:2016, iso 13485 2016 standard, iso 13485 standards iso 13485 clauses, eu medical device regulation
Event listing ID:
1391354
8
21 CFR Part 11 and QMS Software Risk-Based Implementation
16 Dec 2020 • SanJose – online, United States
Organizer:
Complianceonline
Abstract:
CGMP-compliant companies must develop / implement formal software controls and usage, starting with proper verification and validation methods. This is an important consideration for a company’s Quality Management System (QMS) and must consider applicable elements of electronic records / signatures / Part 11. The US FDA recently added data integrity and cybersecurity to these requirements. These activities must be properly documented.
Contact:
Phone: [+1-888-717-2436];     Email: referral@complianceonline.com
Topics:
CGMPs, ISO 13485, CGMPs, 21 CFR 820, 21 CFR 11, 21 CFR 211, QMS, software, firmware, PLC ladder logic, software testing, software development, software usage, software lifecycle, software verification, software validation, data integrity, cybersecurity
Event listing ID:
1385770
Related subject(s):
9
21 CFR Part 11 and QMS Software Risk-Based Implementation
16 Dec 2020 • SanJose – online, United States
Organizer:
Complianceonline
Abstract:
CGMP-compliant companies must develop / implement formal software controls and usage, starting with proper verification and validation methods. This is an important consideration for a company’s Quality Management System (QMS) and must consider applicable elements of electronic records / signatures / Part 11. The US FDA recently added data integrity and cybersecurity to these requirements. These activities must be properly documented.
Contact:
Phone: [+1-888-717-2436];     Email: referral@complianceonline.com
Topics:
CGMPs, ISO 13485, CGMPs, 21 CFR 820, 21 CFR 11, 21 CFR 211, QMS, software, firmware, PLC ladder logic, software testing, software development, software usage, software lifecycle, software verification, software validation, data integrity, cybersecurity
Event listing ID:
1385877
Related subject(s):


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Last updated: 27 November 2020