Validation, compliance and documentationStories that report on the information and documentation involved in complying with verification, qualification, and validation guidelines and regulations from agencies and organizations, including quality-related issues.Validation insights for medical device packagingMedical device packaging validation can be confusing, so here are a few helpful resources to guide your efforts.... Validation, compliance and documentation | December 15, 2009 Compliance Checklist for FDA-regulated Companies Now Available from Dickson CompanyWorldwide food and drug companies selling to the U.S. market can now obtain a free FDA 21 CFR Part 11 Checklist to ensure full regulatory compliance of their environmental monitoring practices.... Validation, compliance and documentation | December 7, 2009 Compliance risks and package validation mistakesExamining common medical device package development/validation errors, and five compliance risks facing life-science firms.... Validation, compliance and documentation | November 20, 2009 Manage your validation missions with GxP Manager*As a Validation Manager, you know the validation team is usually the last on the scene when money and time have run out!... Validation, compliance and documentation | November 10, 2009 First DataBank Joins Health 2.0 Accelerator Consortium and Partners with PharmaSURVEYOR*First DataBank, a leading provider of integrated drug databases for the healthcare industry, today announced that it will join PharmaSURVEYOR and a growing list of "Health 2.0 companies" as participants in the Health 2.0 Accelerator, a consortium focused on promoting... Validation, compliance and documentation | October 15, 2009 Inventory control software• FastPic5® software for health care users provides improved tracking, validation, and traceability... Controls and automation | August 25, 2009 Outsert systems• MV-08 (shown) is a single knife-folder system that folds evenly sealed outsert leaflets with up to 110 panels... Pharmaceuticals and biologics | July 28, 2009 A change of course for pharmaceutical manufacturingThe FDA’s Quality-by-Design initiative holds potential to transform the pharmaceutical industry’s approach to drug development and manufacturing.... FDA, regulatory and legal | June 30, 2009 Health professionals express ESD concernsDuring HealthPack 2009 in Memphis, several conference users and attendees outlined issues pertaining to static electri-city with packaging materials, electrostatic discharge (ESD)-protective compliant packaging, and electrostatic attraction (ESA) observations with packaging.... Medical devices | June 15, 2009 Machine vision inspection system• IMprints™ CodeMatch enables pharmaceutical companies to begin building an e-Pedigree-compliant packaging line system • this addition to the IMprints Track & Trace Solutions suite provides a range of inspection tools for validation and verification of label information •... Inspection, verification and vision systems | May 19, 2009 Blister documentation package• comprehensive Quality Documentation Package comes at no charge with every set of the company’s blister tooling • includes everything necessary for tooling validation, including inspection documents, material data sheets, and material safety data sheets • a similar package... Validation, compliance and documentation | May 6, 2009 Bauer’s pharmaceutical handbook lends ‘Hall of Fame’ packaging perspectiveProfessionals and students will benefit from an informative research tool now available for the healthcare packaging community.... Pharmaceuticals and biologics | April 10, 2009 ESD-safe packaging considerations for microprocessor-driven medical devicesMedical and pharmaceutical professionals must adhere to protective measures in safeguarding ESD-sensitive devices against electrostatic discharge.... Medical devices | February 15, 2009 GlaxoSmithKline, Abbott, and contract packaging panel highlight Pharmaceutical Packaging ForumThe third-annual Pharmaceutical Packaging Forum (PPF) will deliver information you can use on pharmaceutical package design, increasing quality and productivity, patient compliance, strategies to combat counterfeiting, how to increase packaging line profitability, and will include a contract packaging panel, and... Misc. Archive | January 22, 2009 Three testing tips for medical device packagesSterile medical device package testing is a requirement for compliance to ISO 11607 "Packaging for Terminally Sterilized Medical Devices", Part 1: Requirements for materials, sterile barrier systems and packaging systems, and Part 2: Validation requirements for forming, sealing and... Medical devices | January 5, 2009 Cost pressures cloud healthcare packaging's futureMounting financial pressures top a list of issues driving the pharmaceutical, biologic, and medical device sectors. In an exclusive interview, Freedonia senior healthcare consultant Bill Martineau discusses where packaging fits into these issues. Even before the recent global financial... Misc. Archive | December 18, 2008 Packaging vaccines for pandemic flu or bioterrorist attack: Are we ready?A Congressional blue-ribbon panel believes, "Terrorists are likely to use a weapon of mass destruction somewhere in the world in the next five years," according to a Dec. 2 CNN report. Biological weapons are more readily available than nuclear... Pharmaceuticals and biologics | December 15, 2008 Podcast: Serialization matters: What pharmaceutical packagers need to knowIn this exclusive podcast from Pack Expo 2008, Anne Marie Mohan, senior editor of Packaging World, speaks with Bruce A. Harder, Systech International's director of business development. Harder provides an overview on what constitutes a complete serialization solution and... Anti-counterfeiting, track-and-trace, authentication | December 15, 2008 CHPA issues voluntary pediatric cough and cold label updates"Throughout the 2008-2009 cough and cold season, manufacturers will be transitioning onto store shelves oral pediatric cough and cold medicines with new labels and packaging. As with other OTC [over-the-counter] labeling changes in the past, FDA [U.S. Food and... Labels | December 15, 2008 Seven essentials for successful medical package design and validationIndividuals responsible for medical device packaging system design and validation are required to provide a safe and effective packaging system that can deliver the enclosed product to the end user without incurring defect or risk to patient safety. In this... Medical devices | October 30, 2008 * indicates a sponsored article that was submitted directly to this Web site by the supplier, and was not handled by the Healthcare Packaging editorial staff. 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