QRM

Arriello appoints experienced biotech expert, Kate Coleman, as VP of Quality & Compliance

Retrieved on: 
Wednesday, September 20, 2023
Trinity College, Industrial microbiology, Microbiology, Senior, Face, Administration, Culture, Bachelor, Fear, Risk management, Quality management, University College Dublin, ATMP, Kate, Research Quality Association, Marketing, Trinity College Dublin, QP, QRM, Quality control, Risk, QA, Master of Science, Quality assurance, Growth, Dublin Institute of Technology, Regulatory affairs, API, Vaccine, Marketing authorisation, Conference, Regulation, QMC, Audit, Pharmaceutical industry, Nursing, EU, Pharmacovigilance, Quality, Sanofi

DUBLIN, Sept. 20, 2023 /PRNewswire-PRWeb/ -- Arriello, a leading provider of integrated Regulatory Affairs, Pharmacovigilance and Auditing & QA solutions and services, has announced that industrial microbiology and quality risk management specialist Kate Coleman, will join the company in September as VP of Quality & Compliance. She joins from PharmaLex, where she was Senior Director/Principal Consultant for Quality Management and Compliance and QMC Head of the UK/Ireland region.

Key Points: 
  • DUBLIN, Sept. 20, 2023 /PRNewswire-PRWeb/ -- Arriello , a leading provider of integrated Regulatory Affairs, Pharmacovigilance and Auditing & QA solutions and services, has announced that industrial microbiology and quality risk management specialist Kate Coleman , will join the company in September as VP of Quality & Compliance.
  • She joins from PharmaLex, where she was Senior Director/Principal Consultant for Quality Management and Compliance and QMC Head of the UK/Ireland region.
  • This last accomplishment, gained in 2009, means Kate can act as a Qualified Person (QP) for clients in the EU.
  • Here she will present on the theme of "QRM and Quality - Making sure fear doesn't undermine your QRM programme" - exploring the purpose of Quality Risk Management.

Global Cell and Gene Therapy Manufacturing QC Market Expected to Reach $10.65 Billion by 2033, Witnessing a CAGR of 16.85% - ResearchAndMarkets.com

Retrieved on: 
Wednesday, August 16, 2023
Biotechnology, Genetics, Health, Gene, QC, NGS, Sartorius AG, Chromatography, Merck Group, MEA, Medicine, Research, Mass spectrometry, ELISA, Organization, Information International, Inc., CAR, QRM, Thermo Fisher Scientific, Patient safety, Flow cytometry, Kidney, Cell, PAT, LAL, Center for Urban and Regional Analysis, Electrophoresis, Therapy, Benchmarking, Eurofins Scientific, PCR, Safety, Automation, LATAM, Fine chemical, Pharmaceutical industry

The "Cell and Gene Therapy Manufacturing QC Market - A Global and Regional Analysis - Analysis and Forecast, 2023-2033" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Cell and Gene Therapy Manufacturing QC Market - A Global and Regional Analysis - Analysis and Forecast, 2023-2033" report has been added to ResearchAndMarkets.com's offering.
  • The global cell and gene therapy manufacturing QC market was valued at $1.95 billion in 2022 and is projected to reach $10.65 billion by 2033, with a CAGR of 16.85% during the forecast period from 2023 to 2033.
  • The demand for QC in cell and gene therapy manufacturing is driven by the growing production of therapies and increasing approvals for cell and gene therapies.
  • The global cell and gene therapy manufacturing QC market is on a growth trajectory, and key players are leveraging advancements in technology to drive improvements in product quality and safety.

Biomanufacturing Facility Design: The Impact of Annex 1 and Contamination Control Strategy, Upcoming Webinar Hosted by Xtalks

Retrieved on: 
Thursday, August 17, 2023
Learning, CCS, QRM, ATMP, CPIP, Risk management

TORONTO, Aug. 17, 2023 /PRNewswire-PRWeb/ -- In this webinar, the featured speaker will highlight the path to process efficiency and risk mitigation, in compliance with Annex 1 for the design and control of biomanufacturing facilities, along with a plan for integrating the Contamination Control Strategy (CCS). Contamination control plays a pivotal role in safeguarding biomanufacturing processes, and the revised Annex 1 regulations highlight the importance of implementing a comprehensive CCS rooted in Quality Risk management (QRM) principles.

Key Points: 
  • In this free webinar, discover the potential of a well-planned Contamination Control Strategy (CCS) and address contamination control practices that can help transform a facility's performance and take biomanufacturing operations to the next level.
  • The featured speaker will discuss proven assessment tools used by the industry to calculate risk.
  • Contamination control plays a pivotal role in safeguarding biomanufacturing processes, and the revised Annex 1 regulations highlight the importance of implementing a comprehensive CCS rooted in Quality Risk management (QRM) principles.
  • Join Jeff Odum, CPIP, Practice Lead, ATMPs and Biologics, Genesis AEC , for the live webinar on Wednesday, September 13, 2023, at 1pm EDT (10am PDT).

Insights on the Micro Computed Tomography Global Market to 2027 - Featuring Bruker, PerkinElmer and Thermo Fisher Scientific Among Others

Retrieved on: 
Wednesday, January 19, 2022
CAGR, Research, Application, PerkinElmer, Artifact, Tooth, Dentistry, X-ray, COVID-19, X-ray microtomography, Growth, Cardinal, Bone, Bruker, Cancer, Porosity, Animal, QRM, CT, TESCAN, Therapy, Investment, Workforce, Plant, 3D, Software, Prevalence, Globe, Osteoporosis, Thermo Fisher Scientific, Hospital, Hormone, Organization, Analysis, List of life sciences, Medical imaging

The Global Micro Computed Tomography Market size is expected to reach $342.5 Million by 2027, rising at a market growth of 10% CAGR during the forecast period.

Key Points: 
  • The Global Micro Computed Tomography Market size is expected to reach $342.5 Million by 2027, rising at a market growth of 10% CAGR during the forecast period.
  • This high demand for Micro Computed Tomography in the oil and gas sector is expected to augment the growth of the micro computed tomography market.
  • In addition, the chances of artifacts in the data generated by Micro Computed Tomography is one of the major limitations of Micro Computed Tomography imaging.
  • Based on the Analysis presented in the Cardinal matrix; Thermo Fisher Scientific is the forerunners in the Micro Computed Tomography Market.

ISPE Publishes ISPE Good Practice Guide: Good Engineering Practice (Second Edition)

Retrieved on: 
Monday, November 22, 2021
GxP, ICH, Adoption, Q10, Medication, Guide, Retirement, Associate Director of National Intelligence and Chief Information Officer, Compliance, Canadian Capacity Guide For Signalized Intersections, Engineering, Solution, Edition, GEP, Association, Update, QRM, ISPE, CAI, Doctor of Philosophy, Bayer, Good engineering practice, International Society, Risk management, Medical device, Pharmaceutical industry

NORTH BETHESDA, Md., Nov. 22, 2021 /PRNewswire-PRWeb/ --The International Society for Pharmaceutical Engineering (ISPE) announces the release of its latest Guide in November 2021, ISPE Good Practice Guide: Good Engineering Practice (Second Edition) .

Key Points: 
  • NORTH BETHESDA, Md., Nov. 22, 2021 /PRNewswire-PRWeb/ --The International Society for Pharmaceutical Engineering (ISPE) announces the release of its latest Guide in November 2021, ISPE Good Practice Guide: Good Engineering Practice (Second Edition) .
  • The ISPE Good Practice Guide: Good Engineering Practice (Second Edition) defines the practices and processes under Good Engineering Practice (GEP) that support and enable the design, delivery, and operation of engineered systems.
  • The scope of GEP covers the complete lifecycle of engineering projects and engineered systems from conceptual design to retirement.
  • Purchase the ISPE Good Practice Guide: Good Engineering Practice (Second Edition) online either digitally or in a bound copy, at ISPE.org/Publications/Guidance-Documents .

FDAnews Announces Pharmaceutical Quality Risk Management: Navigating the Intersection Between Regulatory Requirements & Risk Management Webinar Jan. 19, 2021

Retrieved on: 
Friday, January 8, 2021
Articles, Actuarial science, Academic disciplines, Security, Project management, Risk analysis, Risk management, QRM, Risk, Quick response manufacturing

FALLS CHURCH, Va., Jan. 8, 2021 /PRNewswire-PRWeb/ --Pharmaceutical Quality Risk Management:

Key Points: 
  • FALLS CHURCH, Va., Jan. 8, 2021 /PRNewswire-PRWeb/ --Pharmaceutical Quality Risk Management:
    Risk is everywhere.
  • If one is struggling to manage the types and severity of risk with quality risk management (QRM) techniques, you are not alone.
  • QRM must be applied consistently to an ever-increasing roster of drug development, manufacturing, distribution and inspection and submissions review processes.
  • If one is exerting a huge effort but still feel adrift, this webinar is the answer.

FDAnews Announces -- Pharmaceutical Quality Risk Management: Navigating the Intersection Between Regulatory Requirements & Risk Management Webinar July 29, 2020

Retrieved on: 
Wednesday, July 15, 2020
Articles, Academic disciplines, Actuarial science, Economy, Security, Risk analysis, QRM, Risk management, Risk, Systems engineering, Inspection, Quick response manufacturing

Struggling to manage the types and severity of risk with Quality Risk Management (QRM) techniques?

Key Points: 
  • Struggling to manage the types and severity of risk with Quality Risk Management (QRM) techniques?
  • QRM must be applied consistently to an ever-increasing roster of drug development, manufacturing, distribution, and inspection and submissions review processes.
  • If one is exerting a huge effort but still feels adrift, this webinar is the answer.
  • Come away with the tools needed to ensure the QRM works to keep one compliant and moving forward.