CGMP-specific phosphodiesterase type 5

2 Day Virtual Section 522 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) Seminar: U.S. FDA CGMP Expectations/Requirements for Post Market Surveillance and Complaint Handling - ResearchAndMarkets.com

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금요일, 11월 17, 2023
Education, FDA, Training, Health, CGMP, Complaint, Safety, CGMP-specific phosphodiesterase type 5, CFR, CAPA, RAPS, MDR, Risk, DHF, US FDA, RAC, Phase, Failure, QSR, FD, Public, Medical device

The "Establish a Compliant Medical Device Post Market Surveillance and Complaint Handling System" training has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Establish a Compliant Medical Device Post Market Surveillance and Complaint Handling System" training 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.
  • Data collected under post-market surveillance helps to address important public health questions on the safety and effectiveness of a device, often resulting in improvements in device design and manufacture.

ISPE Unveils First of Its Kind Guidance Document and Launches New Community of Practice on Pharmaceutical Compounding

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화요일, 9월 19, 2023
NORTH, ISPE, CGMP, Pharmacy, Community of practice, Medication, Federal Food, Drug, and Cosmetic Act, Thought, CGMP-specific phosphodiesterase type 5, Patient, Guide, Compounding, Knowledge, FDA, FD, International Society, Food, Pharmaceutical industry, Internet service provider, Medical device

NORTH BETHESDA, Md., Sept. 19, 2023 /PRNewswire-PRWeb/ -- The International Society for Pharmaceutical Engineering (ISPE) is proud to introduce two significant initiatives aimed at benefitting the field of pharmaceutical compounding—the release of the "ISPE Guide: 503B Compounding – Regulatory Basis and Industry Good Practices for Outsourcing Facilities" and the launch of the ISPE Community of Practice (CoP) on Pharmaceutical Compounding.

Key Points: 
  • ISPE is proud to provide critical guidance to the pharmaceutical compounding industry with the release of the "ISPE Guide: 503B Compounding – Regulatory Basis and Industry Good Practices for Outsourcing Facilities" and the launch of the ISPE CoP on Pharmaceutical Compounding.
  • Recognizing the pressing need for best practice sharing, training, and guidance for creative problem solving in compounding pharmacies, ISPE launched a new ISPE Community of Practice (CoP) on Pharmaceutical Compounding.
  • "ISPE is proud to provide critical guidance to the pharmaceutical compounding industry with the release of the "ISPE Guide: 503B Compounding – Regulatory Basis and Industry Good Practices for Outsourcing Facilities" and the launch of the ISPE CoP on Pharmaceutical Compounding," said Tom Hartman, ISPE President & CEO.
  • We believe these initiatives will play a pivotal role in shaping the future of pharmaceutical compounding, ultimately benefitting patients and communities worldwide."

Crossject reports successful completion of European and U.S. audits for manufacturing of ZENEO® Midazolam for epileptic seizures

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화요일, 9월 5, 2023
BSI, Biomedical Advanced Research and Development Authority, Emergency, Office of Inspector General, U.S. Department of Health and Human Services, National Agency for Food and Drug Administration and Control, ISO, Safety, Human services, Food and Drug Administration, Medication, NextGen Healthcare, Certification, CGMP-specific phosphodiesterase type 5, Administration, Seizure, Development, CGMP, Administration for Strategic Preparedness and Response, ANSM, ISIN, FDA, BARDA, Food, Medical device, Pharmaceutical industry, Health, Euronext, Atlantic Ocean

‘‘These positive reports from both sides of the Atlantic are an important demonstration of Crossject’s stringent manufacturing and quality systems standards.

Key Points: 
  • ‘‘These positive reports from both sides of the Atlantic are an important demonstration of Crossject’s stringent manufacturing and quality systems standards.
  • These are essential for Crossject to ensure quality and bring our products to market in Europe and the United States,” said Patrick Alexandre, CEO of Crossject.
  • “ZENEO® Midazolam will provide a new, simple and reliable method of administering emergency treatment of status epilepticus seizures, delivering life-saving medicine rapidly and accurately.
  • Crossject Dijon and Gray sites met all the requirements for manufacturing and control of its auto-injector device under Quality Systems and CGMPs.

3-Day Online GMP Master Class 2023: Deep Dive into Regulations Governing Good Manufacturing Practices and FDA Inspections - ResearchAndMarkets.com

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화요일, 7월 11, 2023
Other Manufacturing, FDA, Manufacturing, Biotechnology, Training, Pharmaceutical, Health, Science, Education, Other Science, Knowledge, CGMP-specific phosphodiesterase type 5, GMP, Good, Risk management, CFR, Good manufacturing practice, CGMP, Synthase, Dietary supplement, Medical device, Vaccine

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.

Key Points: 
  • 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.
  • It is crucial, for any entity to be compliant, that every individual within the organization fully understand and adhere to these regulations.
  • Adherence to those regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations.
  • What are the regulations governing Good Manufacturing Practices?

Part 11 Data Integrity and Cybersecurity Developments, 2023 Webinar

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수요일, 2월 15, 2023
FDA, Record, CGMP-specific phosphodiesterase type 5, Computer security, Title 21 CFR Part 11, Prevalence, Hacking, Documentation, CGMP, Data integrity, Medical device, Agency

DUBLIN, Feb. 15, 2023 /PRNewswire/ -- The "Part 11 Data Integrity and Cybersecurity - The Latest Developments" webinar has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, Feb. 15, 2023 /PRNewswire/ -- The "Part 11 Data Integrity and Cybersecurity - The Latest Developments" webinar has been added to ResearchAndMarkets.com's offering.
  • Data integrity has always been a key component of all the cGMPs, only now taking on greater emphasis due to the use of electronic records/signatures.
  • Initially, there were regulations such as 21 CFR Part 11 in the U.S. and Annex 11 in Europe.
  • As a result, the FDA has mandated further requirements to be taken by regulated industries to better control data integrity and the cybersecurity threat, in validations, cGMP documentation, and submissions to the Agency.

MIMEDX Appoints Ricci S. Whitlow as Chief Operating Officer

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화요일, 1월 3, 2023
Newton, Good tissue practice, Medtech, Kinetic Concepts, Good manufacturing practice, Texas A&M University, Industrial engineering, Johnson & Johnson, Patient, Lifecell, Government, CGMP-specific phosphodiesterase type 5, Tissue, Catalent, NYU, Stem cell, Pharmaceutical industry, Management

MARIETTA, Ga., Jan. 03, 2023 (GLOBE NEWSWIRE) -- MiMedx Group, Inc. (Nasdaq: MDXG) (“MIMEDX” or the “Company”), a pioneer and leader in placental biologics, today announced that it has appointed Ricci S. Whitlow as Chief Operating Officer, a role that will lead the efforts of the Company’s manufacturing, supply chain, procurement, quality, and regulatory functions. Ms. Whitlow joins MIMEDX from Catalent, where she most recently served as President, Clinical Supply Services.

Key Points: 
  • MARIETTA, Ga., Jan. 03, 2023 (GLOBE NEWSWIRE) -- MiMedx Group, Inc. (Nasdaq: MDXG) (“MIMEDX” or the “Company”), a pioneer and leader in placental biologics, today announced that it has appointed Ricci S. Whitlow as Chief Operating Officer, a role that will lead the efforts of the Company’s manufacturing, supply chain, procurement, quality, and regulatory functions.
  • Ms. Whitlow joins MIMEDX from Catalent, where she most recently served as President, Clinical Supply Services.
  • “We are happy to begin 2023 with the addition of Ricci Whitlow to the MIMEDX leadership team,” stated Todd Newton, MIMEDX interim Chief Executive Officer.
  • We believe Ricci is this leader.”
    “I am excited to be joining the MIMEDX team during this important period in the Company’s history,” stated Ms. Whitlow.

GMP Cell Therapy Consumables Global Market Report 2022: Increasing Popularity of Strategic Collaborations Spurs Growth - ResearchAndMarkets.com

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화요일, 1월 3, 2023
Biotechnology, Health, Genetics, Pharmaceutical, Clinical Trials, QC, CPAS, IPSC, Lisocabtagene maraleucel, CGMP-specific phosphodiesterase type 5, GMP, Sartorius, Food, Drug discovery, Therapy, Research, Quality control, COVID-19, CGT, Cryopreservation, Growth, Patient, CGMP, US Foods, FDA, Process, Laurus Labs, Food and Drug Administration, Workflow, Implant, Cell, Pharmaceutical industry, Fine chemical, Vaccine

The "GMP Cell Therapy Consumables Market Forecast to 2028 - COVID-19 Impact and Global Analysis by Product, Cell Therapy, Process, and End Use" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "GMP Cell Therapy Consumables Market Forecast to 2028 - COVID-19 Impact and Global Analysis by Product, Cell Therapy, Process, and End Use" report has been added to ResearchAndMarkets.com's offering.
  • Also, the increasing use of cell therapy to treat various diseases is propelling the demand for cell therapy consumables manufactured according to GMP regulations.
  • The companies in the GMP cell therapy consumables market is making strategic collaborations for the development of new products and cell therapy treatments.
  • The increase in strategic collaborations among market players for cell therapy development has propelled the use of GMP cell therapy consumables to achieve the desired products, which drives the growth of the GMP cell therapy consumables market.

2 Day Life Sciences Good Manufacturing Practices (GMP) Training Course (December 15-16, 2022) - ResearchAndMarkets.com

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금요일, 11월 18, 2022
Education, Health, Chemicals, Plastics, Manufacturing, Other Manufacturing, Pharmaceutical, Training, Knowledge, CGMP, Good manufacturing practice, Synthase, GMP, CGMP-specific phosphodiesterase type 5, Risk management, Dietary supplement, Medical device

The "Good Manufacturing Practices (GMP) for the Life Sciences Training Course" training has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Good Manufacturing Practices (GMP) for the Life Sciences Training Course" 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.
  • Knowledge and skill surrounding the application and practice of GMPs is fundamental to avoiding regulatory issues.
  • Virtually everyone in the health sciences, everyone within the organisation, can benefit and in most cases, is required to attend periodic GMP training.

QuVa Pharma Introduces Innovative Two-Sided Labels for IV Bag Compounded Sterile Products

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화요일, 11월 15, 2022
Health, Quva, Phenylephrine, Safety, Oxytocin, CGMP-specific phosphodiesterase type 5, FDA, IV, Industry, Multimedia, Institute, Approximation error, Hospital, CGMP, Solution, Fine chemical, Medical device, Norepinephrine

SUGAR LAND, Texas, Nov. 15, 2022 /PRNewswire/ -- QuVa Pharma, Inc. announced today that is has developed a two-sided single label for its product portfolio of compounded IV bags. QuVa Pharma developed these new labels in consultation with its customers and in line with the Institute of Safe Medication Practices' (ISMP) 2022 best practice recommendations.

Key Points: 
  • SUGAR LAND, Texas, Nov. 15, 2022 /PRNewswire/ -- QuVa Pharma, Inc. announced today that is has developed a two-sided single label for its product portfolio of compounded IV bags.
  • QuVa Pharma developed these new labels in consultation with its customers and in line with the Institute of Safe Medication Practices' (ISMP) 2022 best practice recommendations.
  • Compounded Oxytocin IV bag product family will be the first to release with these new labels early in first quarter 2023, followed by all high-alert IV bag products like Fentanyl/Bupivacaine epidurals, Norepinephrine, Phenylephrine.
  • The remainder of compounded IV bag product families in QuVa's portfolio will follow throughout 2023.

KRTL International Corp. and Cannabis Global Inc. Form Global Strategic Alliance

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목요일, 10월 6, 2022
Korea, CBD, Growth, CGMP-specific phosphodiesterase type 5, Agreement, South Korea, Research, Â, MJ, Goal, Company, Marketing, CO, CEO, Water, OTC, GLOBE, Intellectual property, Nature, Drug

Cannabis Global is developing state of the art proprietary delivery methods and infusion technologies to allow the Company and its manufacturing partners to infuse hemp and cannabis products using all-natural water-soluble emulsions.

Key Points: 
  • Cannabis Global is developing state of the art proprietary delivery methods and infusion technologies to allow the Company and its manufacturing partners to infuse hemp and cannabis products using all-natural water-soluble emulsions.
  • In addition, Cannabis Global is actively developing all natural nanoparticle and nanofibers hemp and cannabis technologies using pharmaceutical-grade electrospray technologies, for which it has filed for U.S. and international patent protection.
  • Edward Manolos, CEO of Cannabis Global, commented, By working with KRTL we hope to expand upon our ground-breaking hemp and cannabis infusion R&D program.
  • The Company operates its wholly owned subsidiaries, KRTL Biotech, Inc. and KRTL International Corp., with precision and excellence and continues to create and strengthen the KRTL reputation.