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GMP Compliance
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CMU-Developed Microneedle Patches Ready for COVID-19 Fight
Currently seeking researchers who are working on a vaccine against, or treatment for, SARS-CoV-2 to collaborate.
Videos
Lisa Kulick, Carnegie Mellon University
Phillips-Medisize Expands Struer, Denmark Facility
Expands clinical manufacturing capabilities to serve the growing drug delivery device market.
Phillips-Medisize, a Molex company
01.09.20
Materials
|
Molding
Tessy Plastics Expands
The expansion is planned to be part of the “South Plant” located in Elbridge, New York.
Tessy Plastics
01.06.20
BioStem Technologies Appoints Interim CEO
Company also expands leadership team with hiring of senior vice president of Operations.
Globe Newswire
12.09.19
Software & IT
GE Healthcare Introduces Chronicle Automation Software for Cell Therapy
GMP compliant software is specifically designed for cell therapy manufacturing from process development through commercialization.
GE Healthcare
05.15.19
Neurological
Exosystems Debuts Personalized Neuromuscular Rehab Solution
Provides electrical stimulation that helps patients receive therapeutic stimulation and personalized exercises.
PR Newswire
11.13.18
Materials
Selecting Silicone Adhesives for Medical Device Manufacturing
Understanding cure characteristics, temperature, rheology, surface prep, and inhibition simplifies the specification process.
Online Exclusives
Brian Reilly, Business Development Director, Biomaterials, NuSil, an Avantor Company
10.18.18
Professional Development for the Quality/Regulatory Professional
...
James A. Dunning, Principal, QPC Services LLC
10.16.18
SOLABS and Questionmark Partner to Offer Training Compliance for the Life Sciences Industry
Union designed to improve operational efficiency, audit response times and maintain GxP, GCP and GMP compliance.
Business Wire
10.15.18
Secant Group Announces Collaboration With Orgenesis and Atvio Biotech
Companies will develop and commercialize scaffold technologies for advanced cell therapies.
Business Wire
09.07.18
NSF International Launches Online Training on Medical Device Regulations for MDSAP Countries
Online learning modules prepare regulatory compliance officers, auditors for the Medical Device Single Audit Program.
NSF International
06.18.18
NSF Health Sciences Certification Expands Medical Device Certification Team
New appointee has over 10 years of experience in the international medical device and pharmaceutical regulatory field.
NSF International
04.13.18
Software & IT
How an Automated QMS Helps to Keep Up with Regulatory Changes
...
Alexa Sussman, Content Marketing Writer, EtQ
03.15.18
NSF International Adds Former U.S. Regulator to Medical Device Certification and Training Program
FDA veteran tapped as executive director of Medical Device Certification and Training.
NSF International
02.15.18
Contract Manufacturing
|
Diagnostics
Benefits of Outsourcing IVD Assay Manufacturing
Commercialization of new diagnostic tests often requires a contract manufacturer that can fill in the gaps in development.
Online Exclusives
Taryn Reynolds, VP, Operations and Technology, Corgenix Inc.
12.20.17
Comparing cGMP Pharma vs. Device: Subpart E—Control of Components, Containers and Closures
...
James A. Dunning, Owner, QPC Services LLC
11.07.17
Comparing cGMP Pharma vs. Device: Subpart C—Buildings and Facilities and Subpart D—Equipment
...
James A. Dunning, Owner, QPC Services LLC
10.05.17
Comparing cGMP Pharma vs. Device: Subpart B—Organization and Personnel
...
James A. Dunning, QPC Services LLC
09.01.17
Software & IT
Six Document Control Problems for Medical Device Firms to Avoid
...
Rachel Beavins Tracy, EtQ
09.01.17
Comparing cGMP Pharma vs. Device: Subpart A—General Provisions (Part II)
...
James A. Dunning, QPC Services LLC
07.26.17
Comparing cGMP Pharma vs. Device: Subpart A – General Provisions
...
James A. Dunning, Owner, QPC Services LLC
06.06.17
Cardiovascular
Engineering a Heart Valve that Lasts
Next-generation heart valve accurately functions upon implantation and regenerates into long-lasting heart-like tissue.
Wyss Institute at Harvard University
05.18.17
5 Ways the Automated Compliance Management System Provides Value for Your Organization
...
Contract Manufacturing
|
R&D & Design
Navigating the 12 Steps of Medtech Development
Traveling the complex path from concept to completion can be a treacherous trip if not using the right resources.
Dorine Rivers, Ph.D., P.M.P., CEO, Alpha 81 Inc.
03.07.17
Cardiovascular
|
Diagnostics
|
Digital Health
|
Neurological
|
Patient Monitoring
|
Surgical
Four Common Misperceptions of Accelerated FDA Approval
...
Matthew M. Lowe, Executive Vice President, MasterControl
03.07.17
The Simple Guide to a Life Science Recall
...
A Best Practices Guide to Environmental Health and Safety Management Systems
...
Contract Manufacturing
|
R&D & Design
|
Software & IT
Root Cause Investigation for CAPA
...
Emily Ysaguirre, VERSE Solutions
05.06.16
A Best Practices Guide to GMP Compliance Management Systems
...
Contract Manufacturing
GMP Compliance that Spans the Supply Chain
Considerations for Extending the Quality System Beyond Your Enterprise
5 Signs of an Effective Complaint Handling Solution
...
Contract Manufacturing
CAS to become part of Particle Measuring Systems
Company will remain as a product brand within PMS.
Particle Measuring Systems
02.22.16
Contract Manufacturing
|
Testing
Nelson Laboratories Gains Certification from Australia's Therapeutic Goods Administration
Testing lab enlarges its list of Good Manufacturing Practice certifications with latest addition.
Nelson Laboratories
01.05.16
Software & IT
VERSE Solutions Shortlisted by CIO Review as one of the 20 Most Promising QMS Solution Provider
...
Contract Manufacturing
A Guide to Applying the Four Pillars of ICH Q10
Quality Management
Contract Manufacturing
|
Software & IT
VERSE Announces Release of GMP and EHS Module Suites
...
cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics and Medical Devices
...
11.05.13
cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics and Medical Devices
...
08.02.13
Contract Manufacturing
|
Materials
New KGMP Certification for Foreign Manufacturers The KFDA established a new Korea Good Manufacturin
...
11.09.12
Contract Manufacturing
|
Materials
|
R&D & Design
Technical File Preparation Once your company’s B-GMP quality system is in place, you must pre
...
06.11.12
Contract Manufacturing
Quality System Requirements: B-GMP Following classification and BRH selection (as well as INMETRO c
...
06.11.12
cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics and Medical Devices
...
06.30.11
Cardiovascular
|
Contract Manufacturing
|
R&D & Design
|
Software & IT
Terumo Cardiovascular Cited for GMP Violations by the FDA
The company must pay $35 million to the federal government.
Chris Delporte
03.23.11
Cardiovascular
|
Contract Manufacturing
|
R&D & Design
|
Software & IT
FDA Cites Terumo's Cardiovascular Unit for GMP Violations
Company will pay $35 million to the federal government.
03.21.11
Contract Manufacturing
FDA: Medtronic Unit Not Following GMP on Implantable Pacemakers, Leads
The agency also said five medical device reports were not submitted.
Editor
01.11.10
Contract Manufacturing
FDA: Medtronic Unit Not Following GMP on Implantable Pacemakers, Leads
The agency also said five medical device reports were not submitted.
Editor
01.11.10
Contract Manufacturing
|
R&D & Design
Contract Manufacturer Warned for GMP Violations
A recall of Striker devices followed.
Editor
01.12.09
Contract Manufacturing
|
R&D & Design
Contract Manufacturer Warned for GMP Violations
A recall of Striker devices followed.
Editor
01.12.09
Testing
LifeCell Cited for GMP, Quality System Violations
The FDA says the Somerville,NJ-based company did not document potential sealing problems with the Strattice device.
Editor
12.22.08
Testing
LifeCell Cited for GMP, Quality System Violations
The FDA says the Somerville,NJ-based company did not document potential sealing problems with the Strattice device.
Editor
12.22.08
Breaking News
MPO's Most-Read Stories This Week—April 20
Afon Technology Wins Junkosha Technology Innovator of the Year Award
Portal Enables Public to Report Anticompetitive Practices in Healthcare
FDA OKs Lowering Age for Osia Cochlear Implant to 5 Years Old
Clinical Consultants to Provide Regulatory, Development Help to Futura Surgicare
View Breaking News >
CURRENT ISSUE
April 2024
Medical Tubing & Extrusion Experts Offer Perspectives on Industry
Creating Sustainable Surfaces in Med Device Coating and Finishing
Man & Machine: Artificial Intelligence's Impact on Medtech
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