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Machinery & Materials
Logistics & Cold Chain
FDA Lists Mechanisms to Comply With CGMP Requirements for CPs
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
FDA Issues Medical Device Production Computer Software Guidance
The draft guidance provides recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or the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
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
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
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
FDA Finalizes Instructions for Use Guidance
The document clarifies IFU labeling for pharmaceutical manufacturers to help consumers understand complicated instructions when using a drug or biologic.
August 2, 2022
FDA Releases Draft Guidance on Use of Remote Regulatory Assessments
The guidance covers voluntary and statutorily authorized RRAs, but does not change the core requirements of inspections and pre- and post-market authorities.
July 26, 2022
HDA Traceability Seminar in D.C. PLUS Webinar Series
HDA will hold a webinar series (August 11 and 25 and September 15 and 29) prior to the in-person Traceability Seminar taking place October 12 to 14 in Washington D.C. Sessions will cover DSCSA, EPCIS, wholesale distributor services, VRS, and more.
July 22, 2022
Fundamentals of Medical Device Packaging: In-Person Course Oct. 2022
The course, developed through IoPP’s Medical Device Packaging Technical Committee, takes place at McCormick Place at PACK EXPO International in Chicago (class dates: Oct 24-26) in three half-day sessions, totaling 13.5 hours.
July 22, 2022
FDA Holding Webinar on Animal Drug Manufacturing System eSubmitter Tool
The session will provide information about new enhancements to the system used to support the creation of electronic, secure submissions to the FDA’s Center for Veterinary Medicine for review.
June 20, 2022
2022 PDA/FDA Joint Regulatory Conference
Hosted by the Parenteral Drug Association (PDA), the conference takes place Sep 12 - Sep 14, 2022 in Washington D.C.
June 3, 2022
FDA Flexibilities to Yield Millions of Cans of Additional Infant Formula
In the coming months, the FDA will be able to greatly increase the supply of formula, including Abbott EleCare, available to U.S. consumers through international and domestic manufacturing facilities.
May 26, 2022
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Milk Bank Turns to Induction Sealing to Prevent Leaks, Improve Throughput
Leaks during pasteurization were resulting in unacceptable loss rates for donor human milk until Mothers’ Milk Bank of Florida found an induction sealing solution that lets operators take advantage of higher capacity, full-submersion pasteurization.
Get Ready for PACK EXPO International, With More Features Than Ever
Mondi Launches Recyclable Mono-material for Feminine Care Range
Ethicon Chooses Eastman Renew for Sterile Barrier Packaging
5 ways to embrace sustainability in healthcare packaging
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