Quality management system

AmbioPharm Provides an Update on South Carolina Headquarters Expansion

Retrieved on: 
Wednesday, May 17, 2023
Health, Chemicals, Plastics, Manufacturing, Research, Science, Pharmaceutical, Biotechnology, GMP, QMS, Quality management system, API, Toxicology, Multimedia, History, Quality, Investment, Saudi Standards, Metrology and Quality Organization, SPPS, Fine chemical

AmbioPharm , a worldwide leader in peptide API CDMO services, continues growth to meet capacity demands for late phase and commercial peptide production while increasing our sustainability efforts.

Key Points: 
  • AmbioPharm , a worldwide leader in peptide API CDMO services, continues growth to meet capacity demands for late phase and commercial peptide production while increasing our sustainability efforts.
  • In order to meet customer needs, we continue to make state-of-the-art upgrades to our AmbioPharm South Carolina headquarters, including increasing synthesis capacity at this location.
  • These upgrades allow AmbioPharm to continue to support our customers from early phase Toxicology batches through large scale commercial manufacturing, with annual production capacity up to a metric ton.
  • Using our expertise in peptide synthesis, we are able to tackle both simple and complex peptide projects with a proven history of success at research, clinical, and commercial scales.

Computer System Validation for Cloud and COTS Applications Webinar: Learn About FDA's Approach to Modernizing Technology

Retrieved on: 
Monday, May 15, 2023
Cloud, Online, SDLC, Systems development life cycle, Checklist, Software as a service, Infrastructure as a service, Platform as a service, SLA, FDA Center for Devices and Radiological Health, Gentlemen's agreement, QMS, CSA, Service level, Risk management, Risk assessment, Quality, Ship, Thought, Organization, US, Quality management system, Documentation, CSV, Platform, Patient, GxP, Agency, Risk, Service-level agreement, Title 21 CFR Part 11, Knowledge, Device, FDA, Environment, COTS, W3C Markup Validation Service, Automation, Software, Medical device, Design, Property management

DUBLIN, May 15, 2023 /PRNewswire/ -- The "Computer System Validation for Cloud and COTS Applications - Live, Online Training" training has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, May 15, 2023 /PRNewswire/ -- The "Computer System Validation for Cloud and COTS Applications - Live, Online Training" training has been added to ResearchAndMarkets.com's offering.
  • The attendee will learn about FDA's approach to modernizing technology, and how that will benefit both the Agency and industry.
  • We will discuss ways to modernize the System Development Life Cycle (SDLC) approach to Computer System Validation (CSV) by using automated testing tools that will result in a continuous validation of software products.
  • A key element is a risk-based, product quality and patient-centric approach to Computer System Assurance (CSA) vs. the traditional Computer System Validation (CSV) waterfall approach.

Hyliion Achieves ISO 9001 Certification for Quality Management Systems

Retrieved on: 
Thursday, May 11, 2023
Alternative Energy, Energy, Automotive, Trucking, Automotive Manufacturing, General Automotive, Transport, Manufacturing, Certification, PAETEC Holding Corp., Quality management system, Growth, ISO, Multimedia, QMS, NYSE, Organization, Medical device

(NYSE: HYLN) (“Hyliion”), a leader in electrified powertrain solutions for Class 8 semi-trucks, today announced that the company has achieved ISO 9001-2015 certification for its Quality Management Systems at its Cedar Park, TX facility.

Key Points: 
  • (NYSE: HYLN) (“Hyliion”), a leader in electrified powertrain solutions for Class 8 semi-trucks, today announced that the company has achieved ISO 9001-2015 certification for its Quality Management Systems at its Cedar Park, TX facility.
  • View the full release here: https://www.businesswire.com/news/home/20230510005198/en/
    ISO 9001 is a globally recognized standard that specifies requirements for a quality management system (QMS).
  • “We are proud to have achieved ISO 9001-2015 certification, which is a significant milestone for Hyliion.
  • This certification validates our commitment to delivering the highest quality electrified powertrain solutions to our customers and provides a solid foundation for our future growth,” said Dennis Gallagher, Chief Operating Officer of Hyliion.

Québec Nickel Initiates Metallurgical Test Program at Fortin Sill Zone

Retrieved on: 
Wednesday, May 10, 2023
Mining, Minerals, Natural Resources, Canada, Laboratory, CSE, Photograph, AGAT, Metal, QNI, Metallurgical assay, Ducros, Platinum, FSE, Multimedia, Element, Palladium, SGS, Quality management system, HQ, The Company, Gold, Collection, National instrument, Nickel, CRMS, ISO/IEC JTC 1/SC 37, Quality control, National Instrument 43-101, ICP-OES, Project, Copper, CU, Cobalt, Uranium mining, Fine chemical

The objective of the metallurgical work program is to perform a preliminary evaluation of the amenability of the Fortin Sill Zone to produce saleable critical metals-bearing (Ni-Cu-Co-PGE+Au) concentrate.

Key Points: 
  • The objective of the metallurgical work program is to perform a preliminary evaluation of the amenability of the Fortin Sill Zone to produce saleable critical metals-bearing (Ni-Cu-Co-PGE+Au) concentrate.
  • Select photographs of some of the metallurgical test work program drill core provided to SGS Canada.
  • In April 2023, the Company completed several HQ diameter drill holes at the Fortin Sill Zone which will supply fresh material for the metallurgical test work program.
  • SGS has been contracted to complete a scoping level metallurgical test work program to evaluate the amenability of the Fortin Sill Zone to produce a saleable Critical Metals (Ni-Cu-Co-PGE+Au) concentrate(s).

SafetyChain Ranks No. 1 for Food Safety and as a Leader in Quality Management Systems

Retrieved on: 
Monday, May 8, 2023
Workforce, Traceability, Food safety, QMS, Food, Quality Bicycle Products, Overall equipment effectiveness, Quality, OEE, Plant, Production, Quality management system, Growth, Medical device

NOVATO, Calif., May 8, 2023 /PRNewswire-PRWeb/ -- SafetyChain Software, the leading provider of digital plant management designed for process manufacturers, announced they have been listed as the #1 ranked solution in both the Food Safety Management and the Food Traceability Software G2 Spring 2023 Grid® Reports. SafetyChain was also recognized as a Leader on the Quality Management Systems (QMS) Report, and as a High Performer on the Supplier Relationship Management Software Report.

Key Points: 
  • User reviews for the SafetyChain Digital Plant Management platform put SafetyChain in the top lists for Food Safety, Food Traceability, Quality and Supplier Management.
  • NOVATO, Calif., May 8, 2023 /PRNewswire-PRWeb/ -- SafetyChain Software , the leading provider of digital plant management designed for process manufacturers, announced they have been listed as the #1 ranked solution in both the Food Safety Management and the Food Traceability Software G2 Spring 2023 Grid® Reports.
  • SafetyChain was also recognized as a Leader on the Quality Management Systems (QMS) Report, and as a High Performer on the Supplier Relationship Management Software Report.
  • In addition to being a top ranked solution for managing quality, food safety, and suppliers , SafetyChain is recognized as a top solution for process management and Overall Equipment Effectiveness (OEE).

Cadillac Products Packaging Company’s film plant passes ISO 9001:2015 and FSSC 22000 registration audits

Retrieved on: 
Thursday, April 27, 2023
Packaging, Engineering, Chemicals, Plastics, Automotive Manufacturing, Manufacturing, Other Manufacturing, BRC, Medicine, FSSC, CPPC, ISO, Medication, Foodservice, Multimedia, GFSI, NextGen Healthcare, Certification, Quality management system, IMS, DQS, ISO 9001:2015, Food, Safety, Association of Medical / Pharmaceutical Sciences, Audit, Medical device

Cadillac Products Packaging Company (CPPC), a well-established, innovative manufacturer of films and laminations, today announced the company’s film plant in Paris, Illinois has been recommended for registration to both ISO 9001:2015 and FSSC 22000 by its registrar, DQS.

Key Points: 
  • Cadillac Products Packaging Company (CPPC), a well-established, innovative manufacturer of films and laminations, today announced the company’s film plant in Paris, Illinois has been recommended for registration to both ISO 9001:2015 and FSSC 22000 by its registrar, DQS.
  • View the full release here: https://www.businesswire.com/news/home/20230427005790/en/
    “We are very proud of what all of those involved accomplished to achieve both ISO 9001:2015 and FSSC 22000 certifications for our Paris, Illinois manufacturing plant.
  • “ISO 9001:2015 & FSSC 22000 provide the structure to standardize and continually improve our Quality Management System and Food Safety Management System,” said Enzo Lico CPPC’s Director of Quality Systems.
  • This is of particular importance as CPPC also converts its films into laminations used by customers from the company’s GFSI Certified facility in Dallas, Georgia.

Starfrost Maintains High Standards with Successful ISO 9001 Surveillance Audit

Retrieved on: 
Wednesday, April 26, 2023
Motivation, Certification, Quality management system, International Organization (journal), ISO, Medical device, Audit

LOWESTOFT, England, April 26, 2023 /PRNewswire-PRWeb/ -- Starfrost has successfully passed its ISO 9001 Surveillance Audit of the Quality Management System. This achievement validates our commitment to standardising and maintaining the highest level of quality service to our customers while continuously improving processes.

Key Points: 
  • Starfrost has successfully passed its ISO 9001 Surveillance Audit of the Quality Management System.
  • LOWESTOFT, England, April 26, 2023 /PRNewswire-PRWeb/ -- Starfrost has successfully passed its ISO 9001 Surveillance Audit of the Quality Management System.
  • The certification is maintained every year through a "surveillance audit" to show we have practices in place that demonstrate our level of quality.
  • We successfully passed the audit with zero non-conformities, demonstrating the ability of our management system to systematically achieve the audit standard requirements.

Hexion Wins Multiple American Chemistry Council Responsible Care® Awards

Retrieved on: 
Wednesday, April 26, 2023
Other Energy, Sustainability, Environment, Other Manufacturing, Energy, Packaging, Chemicals, Plastics, Manufacturing, ACC, Environmental management system, American Chemistry Council, Hexion, Energy management, Automotive Executive of the Year Award, Senior, Care, ISO, Safety, Electricity, Health, Expo, ISO 9001, Plant, Environmental protection, Quality management system, Steam, Investment, Energy efficiency, Logic, United States Environmental Protection Agency, Environmental Health (journal), Responsibility, Conference, Renewable energy, Hope

Two projects and 14 facilities at Hexion Inc. were named Responsible Care® award winners by the American Chemistry Council (ACC) and honored for excellence in energy efficiency and overall safety performance.

Key Points: 
  • Two projects and 14 facilities at Hexion Inc. were named Responsible Care® award winners by the American Chemistry Council (ACC) and honored for excellence in energy efficiency and overall safety performance.
  • The announcement was made at the 2023 Responsible Care and Sustainability Conference and Expo, which was sponsored by the ACC.
  • “We are pleased to continue our multi-year track record of being named an ACC Responsible Care® award recipient,” said Michael Lefenfeld, President and Chief Executive Officer.
  • Multiple locations: – 14 Hexion facilities were recognized for their achievements in employee health and safety, including 12 plants receiving Certificates of Excellence for meeting the most stringent safety criteria.

SEQUANA MEDICAL SUCCESSFULLY RAISES EUR 15.78 MILLION IN AN EQUITY PLACEMENT

Retrieved on: 
Tuesday, April 25, 2023
Overload, BY, AFRICA, Interest, Heart failure, Liver disease, Partner, Cancer, Pie, Falls, AMERICA, Underwriting, Trial of the century, KBC, EUR, Quality management system, DSR, Prospectus, PMA, Patient, Offering, Ascites, YE, Van Lanschot Kempen, FDA, Security (finance), Pharmaceutical industry, Life insurance, Holding company, Music, Brussels Stock Exchange

Ian Crosbie, Chief Executive Officer of Sequana Medical, commented: "We are very pleased to announce the closing of this financing round, despite challenging market conditions.

Key Points: 
  • Ian Crosbie, Chief Executive Officer of Sequana Medical, commented: "We are very pleased to announce the closing of this financing round, despite challenging market conditions.
  • EUR 15.2 million of which EUR 12.2 million has been spent up to YE 2022 with the remainder to be attributed over 2023/2024;
    (ii)   Preparing the PMA (Pre-Market Approval) filing and review, with planned submission to the FDA in H2 2023.
  • EUR 9.9 million of which EUR 5.4 million has been spent up to YE 2022 with the remainder to be attributed over 2023/2024.
  • EUR 2.2 million of which EUR 0.7 million has been spent up to YE 2022 with the remainder to be spent from 2023 until 2025.

SEQUANA MEDICAL LAUNCHES EQUITY PLACEMENT AND AMENDS CERTAIN EXISTING LOAN AGREEMENTS

Retrieved on: 
Monday, April 24, 2023
CMS, Marketing, Partner, Medicare, DSR, PMA, Patient, Van Lanschot Kempen, RED, Heart failure, Pie, Underwriting, Limited, Offering, Ascites, FDA, BY, CFR, Interest, Centers for Medicare & Medicaid Services, Cancer, AMERICA, Quality management system, Overload, AFRICA, Liver disease, Person, Trial of the century, KBC, EUR, Prospectus, Brussels Stock Exchange, YE, Regulation of tobacco by the U.S. Food and Drug Administration, Food, Pharmaceutical industry, Life insurance, Bank, Holding company, Music, Security (finance), Credit, Management, Republic

EUR 9.9 million of which EUR 5.4 million has been spent up to YE 2022 with the remainder to be attributed over 2023/2024.

Key Points: 
  • EUR 9.9 million of which EUR 5.4 million has been spent up to YE 2022 with the remainder to be attributed over 2023/2024.
  • (i)   Interest expense and a partial repayment of the loan facility with Kreos Capital (total loan cost of EUR 2.4 million up to Q1 2024), resulting from amendments to the above loan agreement, subject to certain conditions;
    (ii)   General corporate and working capital purposes.
  • The Offering shall be structured as a private placement of new shares and subscription rights via an accelerated bookbuilding, which will commence immediately.
  • Trading in Sequana Medical shares on Euronext Brussels will be suspended during the bookbuilding period.