CAPA

ETQ Named "NextGen Digital Transformation Solution Provider" at the 2023 NextGen Solution Provider Awards

Retrieved on: 
Wednesday, September 13, 2023
CAPA, Product marketing, Partnership, Nextgen, QMS, Culture, Organization, Corrective and preventive action, Plant, PPAP, Predictive analytics, Digital transformation, Robotics, Supply Chain Management Review, Artificial intelligence, Trane Technologies, Conference, Trane, Creative industries, Retail, Hexagon

BURLINGTON, Mass., Sept. 13, 2023 /PRNewswire/ -- ETQ, part of Hexagon, the leading quality management system (QMS) provider, today announced that it was named a Digital Transformation Award recipient, as part of the annual NextGen Solution Provider Awards hosted by Supply Chain Management Review. The award recognizes ETQ's role in helping Trane Technologies, a global climate innovator, leverage the ETQ Reliance quality management system (QMS) to enable standard and consistent product quality, better collaboration with suppliers and stronger efficiency and visibility.

Key Points: 
  • BURLINGTON, Mass., Sept. 13, 2023 /PRNewswire/ -- ETQ, part of Hexagon, the leading quality management system (QMS) provider, today announced that it was named a Digital Transformation Award recipient, as part of the annual NextGen Solution Provider Awards hosted by Supply Chain Management Review.
  • The award will be presented to David Isaacson, Vice President, Product Marketing, ETQ, during the NextGen Supply Chain Conference, taking place in Chicago, Oct 16-18, 2023.
  • "We're thrilled to be named a NextGen Digital Transformation Solution Provider," said Isaacson.
  • This year's NextGen Solution Provider Awards honor solution providers that have utilized NextGen supply chain technologies in a project implemented for a customer in the following categories: Robotics, Digital Transformation, Artificial Intelligence, and Predictive Analytics.

Medical Aesthetics Returning to the True of Medicine - The 5th Anniversary Celebration of SHANGHAI MOYOM BIOTECH (APHRANEL)

Retrieved on: 
Friday, August 25, 2023
Social responsibility, GMP, CAPA, Chinese Academy of Medical Sciences COVID-19 vaccine, Interview, Education, Medicine, Iran National Science Foundation, Speech, University of the Chinese Academy of Sciences, Research, Government, Thought, Philosophy, Beauty, Trust, Patient, Love, Diagnosis, Qi, Microparticle, Safety, Reiko True, Dentistry, Typesetting, Management, Fine chemical

Invited representatives of the medical aesthetics industry held a wonderful discussion and joint oath from the perspective of "Practitioners of returning medical aesthetics to the true of medicine".

Key Points: 
  • Invited representatives of the medical aesthetics industry held a wonderful discussion and joint oath from the perspective of "Practitioners of returning medical aesthetics to the true of medicine".
  • Different from other anniversary celebrations, Shanghai MOYOM's 5th anniversary celebration on August 18, 2023 was more like a collision of ideas and a call of value return in the medical aesthetics industry.
  • Shanghai MOYOM's 5th Anniversary Celebration, it is a big gathering of people in the medical aesthetics industry and a big collision of ideas.
  • Shanghai MOYOM Bio is not only an enterprise, but also the practitioner and guardian of the clean environment of the medical aesthetics industry.

MedReg 2023: Annual Medical Device Regulatory Confex - Navigating Regulatory Horizons

Retrieved on: 
Tuesday, August 15, 2023
DMR, CAPA, USS Medregal (SS-480), Federal Food, Drug, and Cosmetic Act, PM, ISO, Calendar, DHR, MDSAP, NextGen Healthcare, Organization, MDR, PMA, Design controls, VPS, Knowledge, DHF, AM, FDA, US FDA, Element, Medical device, Powder metallurgy, EU

DUBLIN, Aug. 15, 2023 /PRNewswire/ -- The "MedReg 2023 - Annual Medical Device Regulatory Confex" training has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, Aug. 15, 2023 /PRNewswire/ -- The "MedReg 2023 - Annual Medical Device Regulatory Confex" training has been added to ResearchAndMarkets.com's offering.
  • Step into the realm of regulatory excellence at MedReg 2023, the Annual Medical Devices Regulatory Confex that promises to revolutionize attendees' understanding of medical device regulations.
  • A compelling picture is painted by envisioning a world where medical device regulations are overlooked - a world that compromises patient safety.
  • MedReg 2023 transcends traditional learning, offering an experience designed to excite, inspire, and invigorate attendees' regulatory spirit.

OOS (Out-of-Specification) and OOT (Out-of-Trend) Investigations Course: Best Practices, Key Components and a Comprehensive Review of the FDA Requirements

Retrieved on: 
Monday, August 14, 2023
Corrective and preventive action, CAPA, OOT, FDA, Documentation, Risk, Comprehensive Reviews in Food Science and Food Safety, OOS, Pharmaceutical industry, Dietary supplement, Risk management

DUBLIN, Aug. 14, 2023 /PRNewswire/ -- The "OOS and OOT Investigations Course - Best Practices, Key Components and a Comprehensive Review of the FDA Requirements" training has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, Aug. 14, 2023 /PRNewswire/ -- The "OOS and OOT Investigations Course - Best Practices, Key Components and a Comprehensive Review of the FDA Requirements" training has been added to ResearchAndMarkets.com's offering.
  • OOS investigations pose a significant challenge in the pharmaceutical industry, often resulting in warning letters due to deficiencies.
  • FDA regulations mandate thorough investigations of out-of-specification (OOS) results, making well-documented and compliant quality management systems essential.
  • However, many companies struggle with understanding the regulatory expectations and proper handling of OOS and OOT (out-of-trend) cases.

MedReg 2023: Annual Medical Device Regulatory Confex - Where Regulatory Excellence Meets Virtual Engagement - ResearchAndMarkets.com

Retrieved on: 
Friday, August 11, 2023
Medical Devices, Health, DMR, CAPA, USS Medregal (SS-480), Federal Food, Drug, and Cosmetic Act, PM, ISO, Calendar, Lung compliance, DHR, MDSAP, NextGen Healthcare, MDR, PMA, Design controls, VPS, Knowledge, DHF, AM, FDA, US FDA, Safety, Element, Medical device, Powder metallurgy, EU

The "MedReg 2023 - Annual Medical Device Regulatory Confex" training has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "MedReg 2023 - Annual Medical Device Regulatory Confex" training has been added to ResearchAndMarkets.com's offering.
  • Step into the realm of regulatory excellence at MedReg 2023, the Annual Medical Devices Regulatory Confex that will revolutionize your understanding of medical device regulations.
  • Why should you make MedReg 2023 a priority on your virtual event calendar?
  • Imagine a world where medical device regulations are disregarded-a world where patient safety is compromised.

TransPerfect Medical Device Solutions Successfully Completes Stringent Johnson & Johnson Supplier Audit

Retrieved on: 
Monday, August 7, 2023
CAPA, IVDR, TransPerfect, PDF, Record, MDS, J&J, MDR, Documentation, PMS, Johnson & Johnson, AI, Automation, Management, Medical device, Encompass

NEW YORK, Aug. 7, 2023 /PRNewswire/ -- TransPerfect Medical Device Solutions (MDS), the world's largest provider of language services and process automation technology to the medical device industry, today announced the successful completion of a stringent supplier requalification audit for industry heavyweight Johnson & Johnson (J&J), with zero findings across the three evaluated categories: critical, major, and minor.

Key Points: 
  • NEW YORK, Aug. 7, 2023 /PRNewswire/ -- TransPerfect Medical Device Solutions (MDS), the world's largest provider of language services and process automation technology to the medical device industry, today announced the successful completion of a stringent supplier requalification audit for industry heavyweight Johnson & Johnson (J&J), with zero findings across the three evaluated categories: critical, major, and minor.
  • The scope of the J&J audit comprised nine different J&J medical device and pharma franchises and 31 different TransPerfect sites, including three primary sites for TransPerfect Medical Device Solutions.
  • The results of the J&J audit serve as a testament to TransPerfect's ongoing dedication to delivering quality and automation for medical device manufacturers.
  • TransPerfect MDS President Marc Miller observed, "J&J was among the first major device makers to run an RFP specifically for the EU Medical Device Regulation (MDR)—and we were honored to be selected as the lead supplier at the time.

OOS (Out-of-Specification) and OOT (Out-of-Trend) Investigations Course: Best Practices, Key Components and a Comprehensive Review of the FDA Requirements - ResearchAndMarkets.com

Retrieved on: 
Friday, July 21, 2023
FDA, Pharmaceutical, Health, Corrective and preventive action, CAPA, OOT, Documentation, Risk, Comprehensive Reviews in Food Science and Food Safety, OOS, Pharmaceutical industry, Dietary supplement, Risk management

The "OOS and OOT Investigations Course - Best Practices, Key Components and a Comprehensive Review of the FDA Requirements" training has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "OOS and OOT Investigations Course - Best Practices, Key Components and a Comprehensive Review of the FDA Requirements" training has been added to ResearchAndMarkets.com's offering.
  • OOS investigations pose a significant challenge in the pharmaceutical industry, often resulting in warning letters due to deficiencies.
  • FDA regulations mandate thorough investigations of out-of-specification (OOS) results, making well-documented and compliant quality management systems essential.
  • However, many companies struggle with understanding the regulatory expectations and proper handling of OOS and OOT (out-of-trend) cases.

Olympus Corp. of the Americas Named Founders Award Winner

Retrieved on: 
Thursday, July 6, 2023
CAPA, Risk, Senior, Q&A, Professional, Founder's Award, Olympus, Multimedia, Creativity, OCA, Diagnosis, Region, Conference, International Emmy Founders Award, Nursing, Management, Woman

CENTER VALLEY, Pa., July 6, 2023 /PRNewswire/ -- Olympus Corp. of the Americas (OCA) announced today that it received the Founders Award for its efforts in providing career advancement opportunities for its administrative professionals.

Key Points: 
  • Presented by the Philadelphia chapter of the Admin Awards, the Founders Award recognizes companies that provide exceptional opportunities for career advancement in both title and compensation for administrative professionals.
  • The Founders Award recognizes OCA for its Olympus Administrative Assistant Alliance initiative or OA3.
  • Formed in 2016, OA3 launched with a goal of nurturing a work environment that supports continuing education, creativity and camaraderie.
  • Traveling between the U.S. and Japan, she toured Olympus facilities in Japan, worked to improve CAPA processes and provide trainings.

Ingevity’s Capa® thermoplastics recognized for providing biodegradable solutions for agricultural and horticultural applications, awarded OK biodegradable SOIL certification

Retrieved on: 
Friday, June 23, 2023
Other Manufacturing, Environment, Packaging, Chemicals, Plastics, Sustainability, Manufacturing, Green Technology, Other Natural Resources, Agriculture, Natural Resources, Adhesive, Plastic, Compost, BPI, Elastomer, ISO, Gasoline, Microplastics, Carbon, Agrochemical, Lubricant, Corporation, Soil, Inspection, OK, NYSE, HOME, Landfill, CAPA, Certification

Ingevity Corporation (NYSE:NGVT) today announced its Capa® polycaprolactone thermoplastic grades obtained the OK biodegradable SOIL certification by TÜV Austria Bureau of Inspection and Certification, confirming Capa thermoplastics completely biodegrade in soil without adversely affecting the environment.

Key Points: 
  • Ingevity Corporation (NYSE:NGVT) today announced its Capa® polycaprolactone thermoplastic grades obtained the OK biodegradable SOIL certification by TÜV Austria Bureau of Inspection and Certification, confirming Capa thermoplastics completely biodegrade in soil without adversely affecting the environment.
  • The SOIL distinction is the fifth TÜV Austria OK certification earned by Ingevity’s Capa thermoplastics products, along with certifications for WATER and MARINE biodegradability and INDUSTRIAL and HOME compostability, and highlights the additional benefits the Capa portfolio offers for agricultural and horticultural products.
  • This certification opens up new opportunities for Ingevity to enter the multi-billion dollar agricultural and horticultural markets using Capa technology.
  • TÜV Austria is a globally accredited authorization company offering independent third-party registration and certification services against various international ISO standards.

Azzur Group Names Quality Management Expert, Brian Salbilla, Director of its Chicago-Based GxP Consulting Operation

Retrieved on: 
Thursday, June 8, 2023
Molecular biology, CAPA, Azur, University, QMS, Northridge, Certified Quality Engineer, Baxter International, Science, Documentation, ASQ, GxP, University of California, Berkeley, Society, American Society for Quality, Nursing, Chicago metropolitan area, Midwestern United States

CHICAGO, June 8, 2023 /PRNewswire/ -- Azzur Group today announces the appointment of Brian Salbilla to Director of Azzur Chicago, Azzur Group 's GxP advisory and consulting operation serving the Greater Chicago region and Midwestern United States.

Key Points: 
  • CHICAGO, June 8, 2023 /PRNewswire/ -- Azzur Group today announces the appointment of Brian Salbilla to Director of Azzur Chicago, Azzur Group 's GxP advisory and consulting operation serving the Greater Chicago region and Midwestern United States.
  • Brian brings to Azzur Group more than 20 years of GxP experience with leading pharmaceutical and medical device companies, specializing in quality management system (QMS) implementation, CAPA, documentation, audits, IT systems, and new product development.
  • Together with Azzur Labs, Azzur Consulting offers unique solutions and testing that affords our clients local, comprehensive services necessary to meet the demands of the industry," said Brian Salbilla, Director of Azzur Chicago.
  • "We are pleased to welcome Brian to the Azzur Group family," said Allison Kerska , President, Azzur Consulting.