Quality assurance

Syngene biologics manufacturing facility to be operational for US and European customers from mid-year

Retrieved on: 
Thursday, March 14, 2024
Bioreactor, Control, TFF, Growth, PROTAC, LPH, DCAT, CGMP, CMC, EMA, Spacecraft, MD, Senior, Quality assurance, US FDA, Unit, Biocon, Perfusion, Fine chemical

BANGALORE, India, March 14, 2024 /PRNewswire/ -- At DCAT 2024 global bio/pharmaceutical manufacturing forum, Syngene International, a global contract research, development and manufacturing organization (CRDMO), will announce that its newly upgraded biologics facility - Unit 3 - would be operational for clinical and commercial supply in the second half of 2024.

Key Points: 
  • The facility will be available for biotech and pharma customers seeking drug substance and drug product contract manufacturing.
  • The Company also has a microbial cGMP facility and a mammalian cell manufacturing facility to extend end-to-end Chemistry, Manufacturing and Control (CMC) development solutions for its global clients.
  • The integration of chromatography systems streamlines the purification processes and enhances the overall efficiency of biologics manufacturing.
  • In total Unit 3 will have around 100 staff for Quality Assurance and Manufacturing, part of Syngene's 600-strong team across its biologics manufacturing services and supporting specialist functions.

UMass Memorial Health Expands Use of Get Well Platform for Social Determinants of Health (SDOH) Screening and Navigation

Retrieved on: 
Tuesday, March 12, 2024
Well, Andrew Kohut, Health, UMass Memorial Health, NCQA, Joint Commission, Caregiver, Health equity, Partnership, Patient, Hospital, Electronic health record, Get, SDOH, Quality assurance, EHR, Medicare, CMS, National Committee

BETHESDA, Md., March 12, 2024 /PRNewswire/ -- Get Well, the global leader in consumer digital patient engagement, today announced that UMass Memorial Health will implement Get Well's Health Equity Social Determinants of Health (SDOH) Screening Solution across the organization. As part of the Get Well 360 platform, the Get Well Health Equity SDOH Screening Solution captures patients' SDOH needs, integrates the data into Electronic Health Records (EHRs), and navigates patients to appropriate resources and community-based organizations (CBOs).

Key Points: 
  • In response, Get Well announced in 2023 the rollout of a health equity solution, which includes SDOH screening and navigation.
  • UMass Memorial Health, Central Massachusetts' largest not-for-profit health care system, will use Get Well's SDOH Screening and Navigation Solution to support care for their more than 50,000 patients in the hospital and 300,000 in outpatient care.
  • "We're incredibly excited to deepen our partnership with UMass Memorial Health," said Michael O'Neil, CEO of Get Well.
  • Get Well Community Navigators will monitor the texts for any questions or needs and connect them with resources such as FindHelp or route them to UMass Memorial Health social workers.

EudraVigilance registration manual

Retrieved on: 
Wednesday, April 3, 2024
Scroll, University, Data analysis, Patient, Account, Organization, MAH, Medicine, Manual, MFL, IAM, VAT, Finalize (optical discs), QAT, Competence, Documentation, Letter, Privacy, HQ2, ServiceNow, Environment, Trust (social science), RP, Table, Record, MPR, European Medicines Agency, Restricted area, Yahoo!, Identity management, Change request, Access, Qualified person (European Union), HQ, MMD, Home, Hospital, Research, Service, Network affiliate, Comment, Access management, OMS, Send, MSSO, ISO, Commercial, European, NCA, NCS, Managed services, Next, Document, EMA, PSMF, Language, MedDRA, AMP, Database, ICSR, Figure, EudraGMP, Dictionary, AMPS, Reproduction, Quality assurance, Identity, Virtual, Q2, SME, Change, Importance, Management, Security, Name, Location, Sponsor, Completeness, ID, 24 Hours, User, Vaccine
Key Points: 

    Q2 Metals Concludes Its 2024 Winter Drill Program at the Mia Lithium Property, James Bay Territory, Quebec, Canada

    Retrieved on: 
    Tuesday, February 27, 2024
    Lithium, Diamond, Lady, Quality control, MIA, News, LIBS, Suite (music), QA/QC, Figure, Mia, Quality assurance, Table, National instrument, PDAC, Metal, Online shopping

    Vancouver, BC, Feb 27, 2024 - (ACN Newswire) - Q2 Metals Corp. (TSXV: QTWO) (OTCQB: QUEXF) (FSE: 458) ("Q2" or the "Company") is pleased to announce it has concluded its winter 2024 drill program ("Winter Drill Program") at its wholly owned, 8,668-ha Mia Lithium Property (the "Property") located in the Eeyou Istchee James Bay Territory of Quebec.

    Key Points: 
    • Vancouver, BC, Feb 27, 2024 - (ACN Newswire) - Q2 Metals Corp. (TSXV: QTWO) (OTCQB: QUEXF) (FSE: 458) ("Q2" or the "Company") is pleased to announce it has concluded its winter 2024 drill program ("Winter Drill Program") at its wholly owned, 8,668-ha Mia Lithium Property (the "Property") located in the Eeyou Istchee James Bay Territory of Quebec.
    • "The winter drill program at the Mia Property has confirmed the spodumene mineralized pegmatite at the western end of the Mia Trend," commented Q2 Metals VP Exploration, Neil McCallum.
    • A total of 20 drill holes were completed on the Mia Trend for approximately 3,085 Metres (Figure 1).
    • A total of 9 additional drill holes were completed along the remainder of the more than 10-kilometre-long Mia Trend.

    Abell Pest Control Sheds Light on Tick Surge

    Retrieved on: 
    Monday, March 11, 2024
    Head, University, Pet, Social media, Tick, Research, DEET, Deer, Temperature, Lyme disease, Infection, Dog, NSF, Skin, Government, Risk, Notifiable disease, Climate, National Pest Management Association, Bacteria, Prognosis, Quality assurance, Water, Cat, Health policy, Survival, Knowledge, Diagnosis, Borrelia burgdorferi, Trust, University of Guelph, Student

    Due to global warming, the recent abnormally warm winter has allowed ticks to move to new areas and lengthen their active season,” explained Aaron Soudant, Director of Quality Assurance at Abell Pest Control.

    Key Points: 
    • Due to global warming, the recent abnormally warm winter has allowed ticks to move to new areas and lengthen their active season,” explained Aaron Soudant, Director of Quality Assurance at Abell Pest Control.
    • Abell Pest Control offers the following tips to avoid tick bites and minimize the risk of Lyme disease:
      Dress Appropriately: Wear long pants, and long sleeves and opt for light-colored clothing to make ticks easier to spot.
    • Abell Pest Control, a leader in pest control solutions, is dedicated to raising awareness about tick-borne illnesses and empowering communities with knowledge and resources for protection.
    • Celebrating 100 years of trust, Abell Pest Control has been safeguarding homes and businesses since 1924.

    Goodside Health Expands Services into Pediatric Primary Health Care

    Retrieved on: 
    Thursday, March 7, 2024
    Well, Child, Committee, Primary health care, WCV, Physician, American Board of Pediatrics, Health, Adolescence, Patient, Primary care, W30, K-12, National Committee, Quality assurance

    AUSTIN & FORT WORTH, TX, March 07, 2024 (GLOBE NEWSWIRE) -- Goodside Health, a renowned leader in closing the gaps in children's healthcare, is proud to announce the expansion of their services into Pediatric Primary Health Care.

    Key Points: 
    • AUSTIN & FORT WORTH, TX, March 07, 2024 (GLOBE NEWSWIRE) -- Goodside Health, a renowned leader in closing the gaps in children's healthcare, is proud to announce the expansion of their services into Pediatric Primary Health Care.
    • By stepping into Primary Care, Goodside Health aims to provide comprehensive and accessible healthcare to children with a focus on their long-term health and wellbeing.
    • Primary Care Patients can now access the care they need conveniently from any Goodside Health location, including scheduled primary care visits, walk-in urgent care available 365 days a year, on-demand telehealth services available 8am–9pm, and school-based services (where available in 1000+ Texas and Florida schools).
    • "We are thrilled to expand our services into Primary Health Care," said Brian White, CEO of Goodside Health.

    Pluri Inc. Announces Appointment of Jim Roosevelt, Jr. to its Advisory Board

    Retrieved on: 
    Wednesday, March 6, 2024
    Therapy, Politics, Public policy, Regenerative medicine, Massachusetts Democratic Party, PLUR, Social, Public health, Government, Affordable Care Act, Plural, Cell, Rule, Health, Social Security, Private sector, Medicare, Harvard Kennedy School, Cambridge Public Library, Patient, Knowledge, Democratic National Committee, Medicaid, National Committee, Quality assurance, Tufts Health Plan

    HAIFA, Israel, March 06, 2024 (GLOBE NEWSWIRE) -- Pluri Inc. (Nasdaq: PLUR) (TASE: PLUR) (“Pluri” or the “Company”), a leading biotech company that transforms cells into solutions that promote global wellbeing and sustainability, today announced the appointment of attorney James Roosevelt, Jr. to the Company’s Advisory Board.

    Key Points: 
    • HAIFA, Israel, March 06, 2024 (GLOBE NEWSWIRE) -- Pluri Inc. (Nasdaq: PLUR) (TASE: PLUR) (“Pluri” or the “Company”), a leading biotech company that transforms cells into solutions that promote global wellbeing and sustainability, today announced the appointment of attorney James Roosevelt, Jr. to the Company’s Advisory Board.
    • The intersection of public policy and health is a passion for him.
    • As CEO of Tufts Health Plan, his leadership achieved consistent profitability while attaining the #1 ranking from the National Committee for Quality Assurance.
    • Mr. Roosevelt is also a trustee of the Cambridge Public Library, the Cambridge Community Foundation, and the Atrius Health Equity Foundation.

    Vantage Hemp Co. Achieves GMP Certification from Australia's Therapeutic Goods Administration

    Retrieved on: 
    Thursday, February 29, 2024
    Standard, TGA, Calibration, GMP, Documentation, Quality control, Therapeutic Goods Administration, Certification, CBD, TGO, Vantage, Good manufacturing practice, Quality assurance

    Greeley, Colorado, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Vantage Hemp Co. (“Vantage” or “the Company”), a globally accredited plant-based extractor and finished product manufacturer, is proud to announce that it has successfully obtained Good Manufacturing Practice (GMP) certification from Australia's Therapeutic Goods Administration (TGA).

    Key Points: 
    • Greeley, Colorado, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Vantage Hemp Co. (“Vantage” or “the Company”), a globally accredited plant-based extractor and finished product manufacturer, is proud to announce that it has successfully obtained Good Manufacturing Practice (GMP) certification from Australia's Therapeutic Goods Administration (TGA).
    • Vantage is establishing a leadership position in key international markets by obtaining formal approval for importation through its demonstration of manufacturing excellence.
    • This milestone not only marks Vantage’s adherence to long-standing GMP pharmaceutical manufacturing standards but also industry-specific regulations including Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017 (TGO 93).
    • The final evaluation concluded that Vantage operates in accordance with the relevant GMP requirements.

    Alvotech Appoints Interim Chief Quality Officer

    Retrieved on: 
    Thursday, February 29, 2024
    Biology, Mallinckrodt, Alvogen, FDA, Temple University, GMP, Regulatory affairs, Bachelor, Norwich Pharma Services, Patient, Heart, Quality assurance, Georgia Tech

    REYKJAVIK, Iceland, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that Christina Siniscalchi will join its corporate leadership team as interim Chief Quality Officer.

    Key Points: 
    • REYKJAVIK, Iceland, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that Christina Siniscalchi will join its corporate leadership team as interim Chief Quality Officer.
    • Christina Siniscalchi has for over ten years served in senior quality positions for Alvogen and its manufacturing site in Norwich, NY, most recently as Alvogen’s Chief Quality Officer.
    • “We thank Sandra for her valuable contribution to Alvotech, as she successfully steered our quality team through the recent FDA facility inspection, which now has led to the approval of our interchangeable high-concentration biosimilar to Humira in the U.S.,” said Robert Wessman, Chairman and CEO of Alvotech.
    • Continuous improvement, quality, and compliance, is at the heart of everything we do.”
      Christina Siniscalchi has 25 years of experience in the U.S. pharmaceuticals industry.

    Berkshire Sterile Manufacturing Announces the Launch of Its Webinar Series, Perfecting Fill Finish

    Retrieved on: 
    Wednesday, February 28, 2024
    Patient safety, CDMO, BSM, Quality assurance, CMO, Introduction, Pharmaceutical industry

    Lee, MA, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Berkshire Sterile Manufacturing (BSM), a Massachusetts-based fill finish CDMO and subsidiary of Sharp , will launch a webinar series, Perfecting Fill Finish , on Wednesday, March 6 at 1PM EST.

    Key Points: 
    • Lee, MA, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Berkshire Sterile Manufacturing (BSM), a Massachusetts-based fill finish CDMO and subsidiary of Sharp , will launch a webinar series, Perfecting Fill Finish , on Wednesday, March 6 at 1PM EST.
    • This webinar series is designed to offer a deep dive into parenteral drug manufacturing, regulatory requirements, and CMO selection for pharmaceutical professionals.
    • The first webinar of the series, Introduction to Fill Finish, airs on March 6 and will offer a foundational understanding of the aseptic fill finish process.
    • Debbie Smith, Vice President of Quality Assurance of Berkshire Sterile Manufacturing, expressed her enthusiasm about the series, stating, "We are thrilled to launch the Perfecting Fill Finish webinar series.