Subscribe
Design & Materials
Sustainability
Machinery
Logistics
Industry News
Downloads
E-Commerce
Market Trends
PMMI News
Quick Hits
Regulatory
Workforce
Regulatory: Page 14
Traceability/Serialization
Experts Still Concerned About Exceptions Under DSCSA
Live from HDA's Traceability Seminar 2022: Data issues may cause double the product holdup when a mismatch of product and data are shipped.
October 13, 2022
Medical Device/Packaging
Initial Call for Papers! ASTM D10 and F02 Packaging Workshop in Denver
Save the Date: The workshop will take place April 19, 2023 in Denver, CO, with discussion to include case studies, regulations, and more. Submit 300-word abstracts to Workshop Co-Chair Henk Blom before October 18, 2022.
October 10, 2022
Traceability/Serialization
DSCSA: Labels Practically as Important as the Medicine Itself
In becoming compliant with interoperable data exchange requirements under DSCSA, don’t overlook the pharmaceutical label itself. Missing case labels or faded inks can pose threats.
October 4, 2022
Regulatory
FDA Lists Mechanisms to Comply With CGMP Requirements for CPs
U.S. Food and Drug Administration
While the FDA has provided examples of mechanisms, CP manufacturers should consider the suitability of an approach in the context of their product and manufacturing process.
September 19, 2022
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The draft guidance provides recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or the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
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
Packaging/Filling
NIST Providing $3M for Biopharma Manufacturing Equipment Advancements
The funding for new equipment will support the advancement of biopharmaceutical manufacturing processes and provide expanded opportunities for workforce development.
September 14, 2022
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
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
Labeling/Printing
Octapharma Employs Schreiner MediPharm Automated Vial Labeling System
Schreiner MediPharm
The Schreiner MediPharm automatic application solution is ideal even for very small quantities.
August 22, 2022
Packaging/Filling
2022 PDA Pre-Filled Syringes Conference and Parenteral Packaging Courses
Held in Palm Springs, CA, the in-person conference takes place Oct.18 - 19 and the courses follow on Oct. 20.
August 22, 2022
Sustainability
FDA Continues Support of Innovation in Medical Device Sterilization
U.S. Food and Drug Administration
A recent statement details the FDA’s efforts to find ways to reduce EtO emissions and concentrations used to sterilize devices without compromising safety and effectiveness.
August 16, 2022
Previous Page
Page 14 of 189
Next Page
Top Stories
Medical Device/Packaging
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.
Pharmaceuticals
Are Bacteria Cellulose Face Masks the Future of Skin Health?
Packaging/Filling
How an Integrated Leaflet Simplifies Pharmaceutical Cartoning
Package Design
What Autonomous Supply Rooms Mean for Healthcare Packaging
Package Development
Designing the Convenience of Tamper Evidence
Products
AI-enabled X-ray Inspection Software Platform
At PACK EXPO, Eagle launches SimulTask 6, which offers food processors advanced image analysis, real-time production monitoring, automated reporting, and task-based inspection.
Integrated Water Insoluble Matter Testing Systems
Induction Sealing Gap System
More Products
In Print
Fall 2026 Healthcare Packaging
Spring 2026 Healthcare Packaging
Fall 2025 Healthcare Packaging
Spring 2025 Healthcare Packaging
Subscribe
Archives
Downloads
View More »
Robotics/Automation
Market Snapshot: Life Sciences Manufacturing
Robotics/Automation
Automation Success on the Line
Labeling/Printing
Beyond the Label: Rethinking Healthcare Packaging
Package Design
Package Design Ideas Transforming Wellness, OTC, and Healthcare Brands
View More »
