CFR

Box Sign Achieves Support for FDA 21 CFR Part 11 Compliance to Streamline Regulated E-signature Workflows

Retrieved on: 
Tuesday, January 16, 2024
Health, Security, FDA, Technology, Software, Clinical Trials, Internet, Cloud, IDC, Research, Data management, Part, Workflow, Safety, CFR, Organization, Automation, Medical device

Box, Inc. (NYSE:BOX), the leading Content Cloud, today announced that its native e-signature product, Box Sign, has achieved support for compliance with FDA 21 CFR Part 11 regulations for electronic signatures.

Key Points: 
  • Box, Inc. (NYSE:BOX), the leading Content Cloud, today announced that its native e-signature product, Box Sign, has achieved support for compliance with FDA 21 CFR Part 11 regulations for electronic signatures.
  • "With the ability to support 21 CFR Part 11 compliance, life sciences customers at Box can make strides forward in their digital transformation journey," said Manu Vohra, Managing Director of Life Sciences at Box.
  • Simplified Compliance: Box Sign Part 11 streamlines compliance by providing a user-friendly interface for senders, signers, and admins.
  • "Enabling Part 11 compliance for Box Sign has been our top priority to support our regulated life sciences customers’ FDA-regulated processes," said Tom Cowles, Chief Compliance Officer at Box.

2024 Annual cGMP (Current Good Manufacturing Practices) Online Master Class

Retrieved on: 
Friday, January 12, 2024
Knowledge, Good manufacturing practice, CGMP, Synthase, Risk management, GMP, CFR, Dietary supplement

DUBLIN, Jan. 12, 2024 /PRNewswire/ -- The "Annual GMP Master Class 2024" training has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, Jan. 12, 2024 /PRNewswire/ -- The "Annual GMP Master Class 2024" training has been added to ResearchAndMarkets.com's offering.
  • cGMPs or Current Good Manufacturing Practices is a general encompassing term for the regulations that the control of all facets of life sciences manufacturing processes and facilities particularly pharmaceutical products.
  • This formal system of controls if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors.
  • Accordingly, the 'c' in cGMP stands for 'current,' requiring companies to use technologies and systems that are up-to-date in order to comply with the regulations.

Cullen/Frost Bankers, Inc. Hosts Fourth Quarter 2023 Earnings Conference Call

Retrieved on: 
Tuesday, January 9, 2024
SAN, CFO, Senior, Webcast, Internet, Multimedia, Conference, Frost Bank, CFR, Central Time, Music

SAN ANTONIO, Jan. 9, 2024 /PRNewswire/ -- Cullen/Frost Bankers, Inc. (NYSE:CFR) will host a conference call on Thursday, January 25, 2024 to discuss fourth quarter 2023 earnings.

Key Points: 
  • SAN ANTONIO, Jan. 9, 2024 /PRNewswire/ -- Cullen/Frost Bankers, Inc. (NYSE:CFR) will host a conference call on Thursday, January 25, 2024 to discuss fourth quarter 2023 earnings.
  • Earnings Release: The earnings release for Cullen/Frost Bankers, Inc. will be available at approximately 8:00 a.m. Central Time (CT) on the internet at https://investor.frostbank.com/ .
  • Conference Call and Live Webcast: The conference call will begin at 1:00 p.m. CT (2:00 p.m. Eastern) and will be hosted by Phil Green, Chairman and CEO, Jerry Salinas, Group Executive Vice President and CFO and A.B.
  • Following the prepared remarks there will be a question and answer session for the analyst community.

Astiva Health Announces Strategic Expansion Across Three Southern California Counties

Retrieved on: 
Tuesday, December 12, 2023
IBN, MAPD, Medicare, CFR

With a profound focus on inclusivity and community well-being, Astiva Health recognizes the diverse healthcare needs of individuals.

Key Points: 
  • With a profound focus on inclusivity and community well-being, Astiva Health recognizes the diverse healthcare needs of individuals.
  • As part of its expansion initiative, Astiva Health aims to provide a more extensive network of care, fostering lasting relationships within these communities.
  • Astiva Health's strategic expansion into these three counties is poised to elevate the company's impact on Medicare Advantage enrollment.
  • Astiva Health invites individuals, healthcare professionals, and the public to explore the opportunities this expansion brings, as the company continues its journey to redefine healthcare accessibility and quality.

DevvStream to Leverage Go-Station’s Network of EV Charging Sites for Carbon Credit Generation

Retrieved on: 
Tuesday, December 5, 2023
Carbon, Climate change, COP28, Conference, NEO, Travel, Partnership, CFR, Interest, DESG, CAD, CleanTechnica, Legislation, Private sector, Level 2, EV, Renewable energy

VANCOUVER, British Columbia, Dec. 05, 2023 (GLOBE NEWSWIRE) -- DevvStream Holdings Inc. (“DevvStream” or the “Company”) (NEO: DESG) (OTCQB: DSTRF) (FSE: CQ0), a leading carbon credit project co-development and generation firm specializing in technology-based solutions, and Go-Station, Inc. (“Go-Station”), an electric vehicle (“EV”) charging company offering a complete range of EV charging services and turnkey solutions, today announced a definitive agreement to leverage Go-Station’s network of EV charging stations in the United States for carbon credit generation.

Key Points: 
  • VANCOUVER, British Columbia, Dec. 05, 2023 (GLOBE NEWSWIRE) -- DevvStream Holdings Inc. (“DevvStream” or the “Company”) (NEO: DESG) (OTCQB: DSTRF) (FSE: CQ0), a leading carbon credit project co-development and generation firm specializing in technology-based solutions, and Go-Station, Inc. (“Go-Station”), an electric vehicle (“EV”) charging company offering a complete range of EV charging services and turnkey solutions, today announced a definitive agreement to leverage Go-Station’s network of EV charging stations in the United States for carbon credit generation.
  • This agreement will establish a new revenue stream for Go-Station, enabling further expansion of the company’s EV charging infrastructure.
  • In exchange for services related to the development and monetization of carbon credits from Go-Station’s EV charging stations, DevvStream will retain a portion of the carbon credits generated.
  • “Go-Station and DevvStream are committed to finding creative financing solutions to deploy charging stations at scale and enhance the EV charging experience for everyone.

SHAREHOLDER ALERT: Pomerantz Law Firm Reminds Shareholders with Losses on their Investment in Kenvue, Inc. of Class Action Lawsuit and Upcoming Deadline – KVUE

Retrieved on: 
Monday, December 4, 2023
Nasal, Food, Risk, Johnson & Johnson, CFR, Phenylephrine, Petition, J&J, LLP, FDA, Ext, Court, Initiative, Find, Person, Nasal congestion, Register, News, Complaint, Pomerantz, KVUE, Prior, Prospectus, Safety, Defendant, District court, Action Replay, Pharmaceutical industry

NEW YORK, Dec. 04, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP announces that a class action lawsuit has been filed against Kenvue, Inc. (“Kenvue” or the “Company”) (NYSE: KVUE) and certain officers.

Key Points: 
  • NEW YORK, Dec. 04, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP announces that a class action lawsuit has been filed against Kenvue, Inc. (“Kenvue” or the “Company”) (NYSE: KVUE) and certain officers.
  • To discuss this action, contact Robert S. Willoughby at [email protected] or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext.
  • Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.

TransPerfect Life Sciences Releases Trial Interactive 10.5

Retrieved on: 
Tuesday, November 28, 2023
Clinical trial, Clinical data management, Documentation, CFR, Biotechnology, Factorization of polynomials, IOS, Patient safety, Language, TMF, Android, Cras, CTMS, Patient, Automation, Communication, Pharmaceutical industry

NEW YORK, Nov. 28, 2023 (GLOBE NEWSWIRE) -- TransPerfect Life Sciences , a leading provider of services and technologies to support global clinical trials and product development for the biopharmaceutical industry, announced the release of version 10.5 of its award-winning Trial Interactive eClinical platform.

Key Points: 
  • NEW YORK, Nov. 28, 2023 (GLOBE NEWSWIRE) -- TransPerfect Life Sciences , a leading provider of services and technologies to support global clinical trials and product development for the biopharmaceutical industry, announced the release of version 10.5 of its award-winning Trial Interactive eClinical platform.
  • Trial Interactive’s user-friendly document and trial management automation helps pharmaceutical, biotechnology, and CRO companies effectively streamline product development lifecycles.
  • A fully connected solution, Trial Interactive offers fast-to-implement and cost-effective solutions in a secure 21 CFR Part 11-compliant environment.
  • “This update of Trial Interactive gives sponsors even more real-time oversight, process automation, and ease of use, as well as a feature-rich mobile experience,” said Michael Smyth, Division President of TransPerfect Life Sciences Solutions.

SHAREHOLDER ALERT: Pomerantz Law Firm Reminds Shareholders with Losses on their Investment in Kenvue, Inc. of Class Action Lawsuit and Upcoming Deadline – KVUE

Retrieved on: 
Tuesday, November 21, 2023
Nasal, Food, Risk, Johnson & Johnson, CFR, Phenylephrine, Petition, J&J, LLP, FDA, Ext, Court, Initiative, Find, Person, Nasal congestion, Register, News, Complaint, Pomerantz, KVUE, Prior, Prospectus, Safety, Defendant, District court, Action Replay, Pharmaceutical industry

NEW YORK, Nov. 21, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP announces that a class action lawsuit has been filed against Kenvue, Inc. (“Kenvue” or the “Company”) (NYSE: KVUE) and certain officers.

Key Points: 
  • NEW YORK, Nov. 21, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP announces that a class action lawsuit has been filed against Kenvue, Inc. (“Kenvue” or the “Company”) (NYSE: KVUE) and certain officers.
  • To discuss this action, contact Robert S. Willoughby at [email protected] or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext.
  • Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.

SOMA.finance Announces Launch of Digital Asset Trading Platform with First Product SOMA Starter

Retrieved on: 
Wednesday, December 20, 2023
Regulation, CFR, Regulation D, Sale, Decentralized finance, MANTRA, Non-fungible token, DEX, ATS, Security (finance), Cryptocurrency

HONG KONG and NEW YORK, Dec. 20, 2023 /PRNewswire/ -- SOMA Finance, Incorporated ("SOMA" & "SOMA.finance"), the joint venture between MANTRA and Tritaurian Capital, Incorporated ("Tritaurian") that is building the critical infrastructure of decentralized finance (DeFi), announced today the launch of the first components of its hybrid decentralized digital platform. The non-custodial SOMA.finance platform will be the world's first compliant hybrid decentralized exchange and launchpad, operated by Tritaurian, and is the first non-alternative trading system (ATS) broker-dealer to be approved for a license to sell digital private placement securities using blockchain technology.

Key Points: 
  • In conjunction with the platform launch, SOMA has filed the Regulation Crowdfunding offering memorandum with the Securities and Exchange Commission for its $SOMA Token sale.
  • The $SOMA token will represent Series A preferred shares in SOMA as both a financial instrument of the company as well as the platform token for SOMA.finance.
  • Following the $SOMA Token sale, the SOMA Starter launch pad, a globally compliant token issuance and capital raising platform will begin operations.
  • The SOMA token will be novel in that it will actually represent a financial interest in SOMA at a corporate level.

2 Day Virtual Training Course on Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems

Retrieved on: 
Tuesday, December 19, 2023
Phase, RAC, CGMP, US FDA, MDR, Risk, CFR, Cosmetic, CAPA, FD, Medicine, FDA, QSR, RAPS, Complaint, Public, Safety, Medical device

DUBLIN, Dec. 19, 2023 /PRNewswire/ -- The "Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems" course has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, Dec. 19, 2023 /PRNewswire/ -- The "Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems" course has been added to ResearchAndMarkets.com's offering.
  • This formal postmarket surveillance is the active, systematic, scientifically valid collection, analysis, and interpretation of data or other information about a marketed device.
  • A more generalized "post market surveillance"/complaint handling is also a requirement under the device CGMPs, 21 CFR 820, -.100 - CAPA, and -.198 - Complaints.
  • "Postmarket Surveillance under Section 522 of the Federal Food, Drug, and Cosmetic Act", Guidance, dated October 2022
    21 CFR 822 - Implementing Sec.