Leaders (UNIVERSAL TAXONOMY HCP): Page 126

Pharmaceuticals
Debut Event Showcases Trends in Drug Manufacturing and Delivery
Connect in Pharma provided a platform where key players in European pharma found innovative, patient-centric and sustainable solutions for strengthening the pharmaceutical supply chain.
September 23, 2022
With educational sessions on the show floor and a gala, attendees were provided many opportunities to connect and problem-solve.
Industry News
Herma US Names New Regional Sales Manager
HERMA
In his new position, equipment expert Michael Harrop will oversee key markets for Herma’s growing North American subsidiary.
September 20, 2022
Michael Harrop, Regional Sales Manager For Herma Us
Adherence/Delivery
Study: Patient Training Gaps Persist for Self-Injection
“If you have a better first experience going into a therapy or medication in that first month or that first try, if you feel comfortable and confident or at least informed, the odds of you staying on that therapy go up significantly,” says Tim McLeroy.
September 20, 2022
The study results showed that patients who have to self-administer are receiving some training, but it’s the quality and type of training that is still lacking or underperforming. (Credit: Noble)
Regulatory
FDA Issues Medical Device Production Computer Software Guidance
U.S. Food and Drug Administration
The draft guidance provides recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or the quality system.
September 15, 2022
Fda Logo, Hi Res
Regulatory
Improve Responses to 483s by Expanding Your Focus
FDA audit observations happen in life science manufacturing. When an issue is found, FDA will be looking to determine if the finding is a one-off, or whether it’s the tip of the iceberg.
September 15, 2022
From left, moderator David L. Chesney, MSJ, principal and general manager, DL Chesney Consulting, LLC with Francis RW Godwin, MBA, office director, OC, CDER, FDA; Daniel DeCiero, consumer safety officer, CBER, FDA; Lance M. De Souza, MBA, director, compliance branch, OMPTO, ORA, FDA; and Marea K. Harmon, consumer safety officer, CVM, FDA.
Labeling/Printing
Label Applicator
WLS, a ProMach product brand
The WLS VVM label applicator efficiently applies temperature-sensitive labels to ensure product efficacy.
September 13, 2022
Wls Vvm Label Applicator
Regulatory
FDA Perspective: COVID-19 Learnings in Communication, Manufacturing
Dr. Peter Marks: “One thing we definitely learned does not work: you can't keep cold capacity. If you have a facility that's completely cold… then you want to try to bring it up to manufacture vaccines, it just doesn't work well.”
September 12, 2022
Dr. Peter Marks, MD, PhD, director, CBER, FDA.
Industry News
Reed-Lane Promotes Josh Goolcharan to Director of Sales & Marketing
Reed-Lane
Executive will oversee CPO’s business development and external messaging, as well as manage customer relationships.
September 9, 2022
Reed Lane Director Of Sales & Marketing Josh Goolcharan
Traceability/Serialization
HDA Statement on FDA Proposed National Standards for Licensure of Distributors and 3PLs
Healthcare Distribution Alliance (HDA)
“...with the deadline to comply with DSCSA’s final phase almost one year away, time is of the essence. That is why HDA urges FDA to align certain sections of the rule as closely as possible so distributors and 3PLs can comply with parallel provisions.”
September 8, 2022
Hda
Materials
Aptar Pharma Acquires Metaphase Design Group
Aptar Pharma
The transaction expands Aptar Pharma’s human factors capabilities, enabling it to continue to put the patient at the forefront of design.
September 7, 2022
Aptar Logo
Industry News
PCI Pharma Opens World-class Clinical Services Center of Excellence
PCI Pharma Services
The Bridgewater, Mass., facility will provide increased flexibility and scalability for secondary packaging, distribution, and cold chain storage of innovative therapies in development.
September 6, 2022
Pci Excellence Center
Sustainability
Biomimicry Institute Highlights Startups in Circularity, Waste Reduction
The Ray of Hope Prize identifies nature-inspired startups from around the globe and fosters their growth by providing sustainable business training, communications support, and opportunities for non-dilutive funding.
September 6, 2022
Images are representative of the mycoremediation process. 1. Lab Cultivated fungi applied to shredded waste materials. 2. Waste is myceliated on-site at manufacturers, recyclers, and waste management companies. 3.Biomaterial can be rendered for commercial and or industrial use into new products.
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When Worst Case Becomes Real: ISO 11607 and the Risk of Packaging Failure
Manufacturers who treat ISO 11607's worst-case clauses as a risk-management tool, rather than a box to check, are far better positioned to keep their packaging, and their products, performing as intended.
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