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September 2020

DOL’s New Overtime Rules Explained: How the Changes Impact Your Organization in 2020 and Beyond

September 30 @ 3:00 pm - 4:30 pm CDT
Training doyens, Online
Aurora, CO 80016-6104 United States
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$159 – $199

OVERVIEW The United States Department of Labor released its new overtime exemption rules, and they went into effect on January 1, 2020. For many employers that means that many of the positions it had previously classified as exempt from overtime requirements will not be any longer – unless these employees receive a salary increase equal to or greater than the new salary threshold. The 2020 federal labor law changes are expected to impact at least a million workers nationwide, and to…

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October 2020

SCCE 2020 Virtual European Regional Compliance & Ethics Conference

October 2

Our Virtual Regional Compliance Conferences provide updates on the latest news in regulatory requirements, compliance enforcement, and strategies to develop effective compliance programs. Watch, listen, and ask questions from the convenience of your home or office, and earn live CCB continuing education units (CEUs) for participation. Who should attend Compliance officers In‑house and outside general counsel Privacy and security officers Regulatory affairs VPs and directors Government agency staff

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Discover the Impact of SDA (Same Day ACH) with Changes in 2021

October 5 @ 1:00 pm - 2:30 pm CDT
Online Event, Compliance Key,364 E Main Street, Suite 1009
Middletown,DE,USA, DE 19709 United States
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$139

Topic : Discover the Impact of SDA (Same Day ACH) with Changes in 2021 Register : https://www.compliancekey.us/webinar/1706/impact-of-same-day-ach-changes/source_ccln Offer : (10% Off) On New Signup Overview With SDA fully implemented and due to a recently approved amendment to the Rules, SDA is expanding with a third window for processing SDA transactions and the dollar limit is increasing for a single SDA transaction. History for Same Day ACH (SDA); it was implemented in three phases, beginning Sept of 2016 and ending in March…

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6-Hour Virtual Seminar – The New EU Medical Device Regulation

October 6 @ 8:00 am - 2:00 pm CDT
Online, Compliance Key,364 E Main Street, Suite 1009
Middletown, DE 19709 United States
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$545.00

In 2012, the Commission adopted a package of measures on innovation in health. The package consisted of a Communication and two regulation proposals to revise existing legislation on general medical devices and in vitro diagnostic medical devices. In particular, the Directives on active implantable medical devices (90/385/EEC) and on medical devices (93/42/EEC) are intended to be replaced by a Regulation on medical devices, while the Directive on in-vitro diagnostic medical devices (98/79/EC) is intended to be replaced by a Regulation…

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6-Hour Virtual Seminar on eCTD Submissions of IND/NDA to the US FDA, EU and Canada

October 7 @ 8:00 am - 5:00 pm CDT
Online, Compliance Key,364 E Main Street, Suite 1009
Middletown, DE 19709 United States
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$545.00

The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies.  Reformatting for multiple submissions is substantially limited.  The CTD has improved the regulatory review processes and enabled implementation of good review practices. The eCTD has increased efficiency for reviewers and improved submission times. …

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6-Hour Virtual Seminar on Master Class for the HIPAA Officer: Protecting Patient Information and Implementing Today’s Privacy, Security, and Breach Regulations

October 7 @ 8:00 am - 2:00 pm CDT
Online, Compliance Key,364 E Main Street, Suite 1009
Middletown, DE 19709 United States
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$545.00

The session begins with overview of the HIPAA regulations and then continues with presentation of the specifics of the Privacy Rule, such as Individual Rights and Uses & Disclosures, and recent and expected changes to HIPAA and other rules such as 42 CFR Part 2 regarding Substance Use Disorder information, including the impacts of required changes in your practices to meet the rules.

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6-Hour Virtual Seminar on Qualification (IQ, OQ, PQ) and Validation of Laboratory Equipment and Systems for Regulated Industries (Pharma, Biotech, Devices, etc.)

October 8 @ 8:00 am - 2:00 pm CDT
Online, Compliance Key,364 E Main Street, Suite 1009
Middletown, DE 19709 United States
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$545.00

This webinar will aim at understanding and scoping out various phases of Qualification activities that will be integrated with the perspectives of Instrument Control, System Suitability Test (SST), Analytical Methods Validation and ensuring Data Integrity for Regulatory Compliance.

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6-Hour Virtual Seminar on Validation and 21 CFR Part 11 Compliance of Computer Systems

October 8 @ 8:00 am - 2:00 pm CDT
Online, Compliance Key,364 E Main Street, Suite 1009
Middletown, DE 19709 United States
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$545.00

This course is appropriate for beginner and experienced person alike. The topics will build on each other and will give you the latest trends in our heavily regulated industry and how to make it easy for yourself while still achieving data integrity. The attendees will be given take away templates that will enable them to build a complete package to meet Data Integrity Requirements for Computerized Systems. We have all heard of Computer Systems Validation & Data Integrity, but do…

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Beyond NanoEHS Risk Assessments – Leading at the Interface of Science and Business

October 8 @ 8:30 am - October 9 @ 3:00 pm CDT
to be a
$1699

Responsible commercialization of new technologies requires leadership at the interface of science and business. For example, advances in materials and applications require a constant attention to the potential risks for the environment, health, and safety (EHS). The development of nanomaterials over the last fifteen years serves as a useful example of a framework for responsibly commercializing new technologies. This course will provide an overview of how to use a tiered-approach framework for identify and mitigating potential risks during the R&D…

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M&A due diligence: Managing potential third-party risks before and after the acquisition

October 13 @ 10:00 am - 11:00 am CDT
Free

Due diligence is key to successfully completing any M&A transaction. Often missed in the overall diligence process are the risks that an acquisition targets’ third parties may hide, since many of them cannot be easily identified through simple check-the-box due diligence. Join our webinar where Andrew Henderson, VP of Products at The Red Flag Group®, will explain how to establish a pre-M&A due diligence strategy and how to handle third party red flags inherited through the acquisition. Key takeaways: Assessing…

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9th International Conference on Pharmaceutical Regulatory Affairs and IPR

October 17
$599

The consultants Meeting on Pharmaceutical Regulatory Affairs and IPR 2020 is planned to be conducted within the month of October 16-17, 2020 Munich, Germany. This Conference is CME & CPD authorised. 2020 are going to be organized around the theme “Revolutions in Cancer Prevention and Diagnosis”. Regulatory Affairs 2020 includes prompt Keynote presentations, Oral presentations, Poster presentations and Exhibitions. The aim of Regulatory Affairs 2020 is to globalize the interest, stimulate analysis, and promulgate information on all aspects of REGULATORYAFFAIRS.…

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SCCE October Basic Compliance & Ethics Academy

October 19 @ 8:00 am - October 22 @ 4:00 pm CDT
$2750 – $3250

Attend SCCE's Basic Compliance & Ethics Academy in Washington, DC October 19-22, 2020. Our Basic Academies are ideal for professionals with some compliance knowledge and experience who are ready to support, enhance and manage a comprehensive compliance program.  They are taught by compliance professionals, hand-selected for their experience and teaching skills. Topics include compliance policies and procedures, education and training, risk assessment, auditing and monitoring, conflicts of interest, and anti-corruption and bribery. Course materials are provided onsite on the first…

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