Regulatory

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Article

Audits of quality systems are required in the medical device industry—but are you conducting your own internal audits on a routine basis? Are you including your packaging operations?


Article

Labeling of genetically modified (GM) food products (so-called Franken foods, according to their critics) has been a hotly contentious issue for at least 20 years now.


Article

Pharmaceutical packaging suppliers have just one year before all U.S. Drug Master Files (DMFs) will need to be submitted electronically.


Company

Cryopak, a subsidiary of TCP Reliable, manufactures items for temperature-sensitive shipping needs, including insulated shipping containers, gel packs, phase change materials and temperature monitoring devices.


Article

Come May 5, 2017, all Drug Master File (DMF) submissions will need to be filed electronically with FDA in a specific format, or they will be rejected.


Article

Pharmaceutical manufacturers have been submitting applications electronically to FDA for years.


Article

FDA's Center for Devices and Radiological Health has posted a list of the guidance documen


Article

What does the FDA’s revision of the Nutrition and Supplement Facts Labels mean for your brand and package design? SGK’s Carol Best shares her views and advice.

 


Article

Packaging, sterilization, and assembling are among the critical processes that could be evaluated.


Article

Many packaging materials, past and present, are generally recognized as safe (GRAS) by the U.S. Food and Drug Administration (FDA), which quickly clears the way for the products to be used commercially.


Article

Many packaging materials are used on the basis that they are “generally recognized as safe” (GRAS) by the U.S.


Audits of quality systems are required in the medical device industry—but are you conducting your own internal audits on a routine basis? Are you including your packaging operations?

Internal audits at planned intervals are expected under 21...


 

By Joan Sylvain Baughan and Cynthia Lieberman 

The U.S. FDA evaluates the safety and suitability of drug packaging as part of the premarket approval process for new drugs. The manner in...


Labeling of genetically modified (GM) food products (so-called Franken foods, according to their critics) has been a hotly contentious issue for at least 20 years now. It has only been in the last few years, though, that momentum built at the...


Pharmaceutical packaging suppliers have just one year before all U.S. Drug Master Files (DMFs) will need to be submitted electronically. As we explained earlier this year, DMF submissions and related documents will need to be filed electronically...


Come May 5, 2017, all Drug Master File (DMF) submissions will need to be filed electronically with FDA in a specific format, or they will be rejected. Such was the word from FDA during its CDER Small Business and Industry Assistance (CDER SBIA) on...


Pharmaceutical manufacturers have been submitting applications electronically to FDA for years. So the agency’s announcement that it intends to switch its current paper system for accepting Drug Master File (DMF) information to an electronic one...


FDA's Center for Devices and Radiological Health has posted a list of the guidance documents it plans to...


Baxter International Inc. announced it is voluntarily recalling two lots of intravenous (IV) solutions to the hospital/user level due to the potential presence of particulate matter, according to a July 17 ...


What does the FDA’s revision of the Nutrition and Supplement Facts Labels mean for your brand and package design? SGK’s Carol Best shares her views and advice.

 

Carol Best, VP, Client Engagement, SGK, presents on the topic “Turning...


Packaging, sterilization, and assembling are among the critical processes that could be evaluated.

By Peter Drechsler, Team Leader, Unannounced Audits, BSI Germany; Gert Bos, Head of Regulatory and Clinical Affairs, BSI...


Several packaging chapters within the U.S. Pharmacopeia—including some mandatory ones—are now being revised and updated, which could significantly influence pharmaceutical packaging development and specifications (tests, methods, and acceptance...


Many packaging materials, past and present, are generally recognized as safe (GRAS) by the U.S. Food and Drug Administration (FDA), which quickly clears the way for the products to be used commercially. However, the GRAS review process itself has...


Many packaging materials are used on the basis that they are “generally recognized as safe” (GRAS) by the U.S. Food and Drug Administration (FDA), a process which can quickly clear the way for products to be used commercially. However, the GRAS...


The California Office of Environmental Health Hazard Assessment (OEHHA) has issued a pre-regulatory draft proposal, which would repeal the current regulatory warning requirements under Proposition 65 and adopt new ones that would require more...


 

How can companies be prepared to make sure they’re keeping up on fast-changing regulations and bans of this popular cushioning material?

 

 

While there are more than 50 expanded polystyrene (EPS) bans in effect for...


California Central Valley Economic Development Corporation (CCVEDC) is a regional marketing group whose mission is to promote job creation in the valley, mountain, and desert communities located within Fresno, Kern, Kings, Madera, Merced, San...


We are a full service independent third party product and package test laboratory. We are centrally located in the Lehigh Valley of Pennsylvania within close proximity to all the major northeastern United States markets.

We offer the best...


Whatever business you’re in, Xcel Energy’s team of energy efficiency specialists can help you save energy and money.  From large facilities to small businesses, we’re here to help you make energy efficiency a priority. Contact them at 1-855-839-...


A Full Range of Vacuum System Components, from Suction Cups and Vacuum Cups, Air, Mechanical and Electric Vacuum Pumps and Vacuum Generators, and Ergonomic Vacuum Lifters, to complete Vacuum Lifting Systems. We are the leading North American...


Representations MM Industrial, SA de CV, a Salvadoran company, with 20 years in the Latin American market as a company with personality natural, then, in 2006, becoming a limited company with variable capital, due to growth in both diversification...


Colorcon® provides a wide range of complete film coatings systems, modified release technologies, and excipients to assist all pharmaceutical and nutritional supplement companies in the development of cost-effective, high quality products with...


Cryopak, a subsidiary of TCP Reliable, manufactures items for temperature-sensitive shipping needs, including insulated shipping containers, gel packs, phase change materials and temperature monitoring devices. We also offer package design and...


As an organisation we work towards a common goal: to consistently deliver to our clients world class ISO consultation, reinforced by adherence to our Missions, Visions and Values.

Our mission is to deliver high quality ISO...


Since 1981, JH Bertrand has been focused on making booklet label and related constructions that expand copy real estate on products. Our family of booklet label products include: Stitched and glue bound booklet labels, booklet labels for curved...


At PaR Systems, we leverage our large base of equipment platforms and applications experience to serve our clients, who come from a variety of industries. Our ability to access legacy platforms and technology expertise (gained from thousands of...


Pharma Packaging Solutions (PPS) is a turn-key contract packager, offering commercial packaging, product launches, stability services, cold chain packaging and product retain services to regulated, healthcare industries.

We offer primary...


Rice Lake Weighing Systems is an international leader in the manufacture and distribution of weight-related products and process-control equipment. Within this ISO 9001 registered company, progressive new technologies merge with the wisdom of...


Rose Mill Company is an ISO9001:2008 certified company that manufactures environmentally responsible products. The Rose Mill manufacturing process does not create any by-products; virtually 100% of the raw materials are used in the final product....


Headquartered in Troy, Michigan, ROSS CONTROLS® is an international manufacturer of pneumatic valves, controls systems, and safety products for the fluid power industry. Since being established in 1921, ROSS has always been one of the industry's...

Wednesday, May 3, 2017 to Thursday, May 4, 2017

BIOMEDevice is New England’s source for every aspect of medical device design and development, including packaging solutions. Find the materials, technologies, ideas, equipment and suppliers you need.

Tuesday, May 16, 2017 to Thursday, May 18, 2017

At PackEx Toronto, benefit from hands-on access to the newest packaging and processing technologies, equipment and materials.

Tuesday, May 16, 2017 to Thursday, May 18, 2017

At ATX Canada 2017, be inspired by the latest technologies and insights applicable to packaging operation, including robotics, motion control, vision, rapid prototyping, software and more.

Tuesday, May 16, 2017 to Thursday, May 18, 2017

Toronto Powder & Bulk Solids 2017 puts you face-to-face with North America’s leading suppliers displaying hundreds of solutions, including packaging, to help accelerate product-to-market.

Tuesday, June 13, 2017 to Thursday, June 15, 2017

EastPack 2017 packages up new technologies and solutions from hundreds of suppliers. Plus, gain insights from the free presentations at Center Stage, Tech Theater and during the Innovation Tours.

Tuesday, June 13, 2017 to Thursday, June 15, 2017

For more than 30 years, MD&M East has been the trusted resource for every aspect of medical device development, including packaging, to take your product from concept to commercialization.

Tuesday, June 13, 2017 to Thursday, June 15, 2017

At ATX East 2017, meet with top automation experts and see solutions geared toward maximizing your packaging productivity and profitability.

Tuesday, June 13, 2017 to Thursday, June 15, 2017

Quality drives productivity and productivity drives revenues. For critical packaging functions, Quality Expo 2017 brings focus to technology, equipment, materials and services that support quality.

Wednesday, November 8, 2017 to Thursday, November 9, 2017

At MinnPack 2017, experience the newest packaging technologies and equipment first-hand, meet suppliers one-on-one and compare solutions side-by-side.

Wednesday, November 8, 2017 to Thursday, November 9, 2017

Attend MD&M Minneapolis 2017 and find everything you need to design and develop the next generation of medical devices and equipment, including packaging solutions.

Wednesday, November 8, 2017 to Thursday, November 9, 2017

ATX Minneapolis 2017 gives you direct access to knowledgeable suppliers, the latest technologies and networking opportunities. Plus it has access to five other related manufacturing events.