dynalabs.us - Industry News

Industry News - DYNALABS

Dynalabs.us Spined HTML

Industry News - DYNALABS 888.396.2522 314.241.3962 888.396.2522   •   314.241.3962   •   info@dynalabs.us LOGIN User Registration Account Registration  Menu Close Login User Registration Account Registration Products & Services Lab Services State-of-the-art tampering testing laboratory provides data you need to run your business. On Site Testing Less than 4 seconds to objectively verify drug identity and strength in your facility. CQI Program Use our expert knowledge of the pharmaceutical industry to help you grow your business. Continuous Quality Improvement (CQI) Consulting Services Customer Improvement System Customer Production System Data Analytics Laboratory Services Test Services Lab Services API (Active Pharmaceutical Ingredient ) list DVx™ On site Drug Verification DVx™ Specifications DVx™ Validation Process DVx™ General FAQs On-site Managed Services Consulting Improvement Systems Production System Six Step Approach DYNALABS OOS Process Online Services Sample Submission Customer Service What We DoHospital Pharmacies Stability of Drug Diversion of Drug In House Training Product Validation Drug Investigation Compounding Pharmacies People: Training Validation Program Materials: Vendor Qualification Program Equipment: Performance Validation Program Process: Process Validation Program Product: Product Validation Program Frequently Asked Questions CompanyOur Story Announcements Announcing a new National Accounts Manager, Christine Versichele. DYNALABS announces new Chief Technology Officer DYNALABS welcomes a new Principal Consultant DYNALABS embarks on $1.2 million expansion DYNALABS Announces a New Vice President of Sales DYNALABS announces Director of Quality & Regulatory Affairs DYNALABS LLC Named One of Inc. 5000 Fastest-Growing Private Companies in 2017 DYNALABS named to the 50 Fastest Growing Companies of 2017 DYNALABS Enhances Antimicrobial Effectiveness Testing for USP Potency Testing for Oxytocin DYNALABS Announces New President DYNALABS investment doubles the size of its testing facility Custom Packing Slip DYNALABS Receives ISO/IEC 17025 Accreditation Entrepreneurial Success SmallMerchantryof the Year 2016 DYNALABS investment doubles the size of its testing facility Enforcing FDA Labeling Policies Entrepreneurial Success Award Events Registrations and Awards Vision, Mission Leadership Partners and Alliances Investor Information ResourcesWebinars Blogs Industry News FDA to Remove APIs from list FDA Drug Shortages The Pharma Reports The Pharma Report | Sept 2018 Tech Bulletin | June 2018 Tech Bulletin | May 2018 Tech Bulletin | April 2018 Tech Bulletin | March 2018 Tech Bulletin | February 2018 Tech Bulletin | January 2018 Tech Bulletin | December 2017 Careers Contact < Home | Resources | Industry News Industry News 18.7M pills lost due to healthcare employee misuse and theft September 10, 2018 The first half of 2018 proved that clinical drug diversion continues to threaten the worthiness of healthcare organizations to provide high-quality patient superintendency and to ensure unscratched medication administration. To read the full article: Click Here Eastern District of Michigan Announces Record Setting Hospital Drug Diversion Penalty Settlement with the University of Michigan Health System August 30, 2018 The United States Attorney’s Office for the Eastern District of Michigan spoken today that the University of Michigan Health System (UMHS) has well-set to pay the United States $4.3 million as part of a settlement resolving allegations that UMHS violated unrepealable provisions of the Controlled Substances Act (CSA), 21 U.S.C. §§ 801-904. To read the full release: Click Here FDA Announces New Drug Shortages TaskGravityAugust 21, 2018 The FDA has spoken the insemination of a drug shortages task force, which the organ said will write some of the underlying structural concerns that requite rise to the recurring supply disruptions that have put such a severe undersong on pharmacy operations and patient care. To read the full article: Click Here FDA And Quality Metrics: Where Do Things (Currently) Stand? July 27, 2018 Are you ready to requite the FDA more? “What?” you ask, as a manufacturer of API and finished goods. Are you ready to requite them increasingly data and information well-nigh your manufacturing process? You think, “Don’t they get all the necessary information from me during their inspections and from my filings?” Well, the wordplay is yes and no. To read the full article: Click Here FDA Bulk Drug List for 503B Facilities July 23, 2018 Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act. Click Here to Download Quality Risk Management 101: Overcoming Common Challenges In QRM Implementation June 27, 2018 This vendible explores challenges with QRM implementation that are shared by many within the industry. To read the full article: Click Here Analyzing 2017 FDA WarningReportsCiting Process Validation, Supplier Controls, & OTC Manufacture June 18, 2018 Shortcomings in data governance and data integrity are a prominent full-length in drug GMP warning reports over the past three years. FDA inspections moreover focused on contracted services including contract manufacture and contract laboratories. To read the full article: Click Here Rethinking The Role Of PackagingDiamondIn DrugMinutiaeJune 6, 2018 Packaging is an important component in the minutiae of various drugs, as it can profoundly stupefy drug stability and safety. To read the full article: Click Here Pharmacists Can Struggle With Substance Use Disorder May 11, 2018 Substance use disorders are related to alcohol, tobacco, cannabis, stimulants, hallucinogens, and opioids. Terms such as ‘abuse’ and ‘dependence’ are no longer used to describe the condition… To read the full article: Click Here Someone, Everyone, Or No One: Who Owns Quality? (And Who Should) May 7, 2018 Who is ultimately responsible for quality/the quality management system? To read the full article: Click Here Hospital Staff With Addictions Stealing Drugs February 3, 2018 When healthcare workers steal the medication prescribed to patients to feed an addiction, the consequences can be catastrophic. W5 investigates the silent epidemic of ‘drug diversion.’ To watch the video: Click Here Microbial Expectations For 503B Compounding Pharmacies January 22, 2018 The Drug Quality and Security Act of 2013 includes a category of compounders known as outsourcing facilities. According to section 503B of the Food Drug and Cosmetic Act (FD&C Act), outsourcing facilities are required to comply with all current good manufacturing practices (cGMPs) and regulations regarding insanitary conditions. To read the full article: Click Here FDA PlansIncreasinglyRestrictive Policy for Bulk Drug Compounding January 18, 2018 The throne of the U.S. Food and DrugWardshipon Thursday said it is preparing a new, increasingly restrictive policy targeting what drugs compounding pharmacies can produce that do not go through the agency’s clearance process. To read the full article: Click Here 2018 Compounding Policy Priorities Plan January 2018 This plan provides an overview of the key priorities our organ will pursue to implement the federal law on compounding and to whop the FDA’s public health mission. To read the full article: Click Here FDA approves first once-monthly buprenorphine injection, a medication-assisted treatment option for opioid use disorder November 30, 2017 FDA approves first once-monthly buprenorphine injection, a medication-assisted treatment option for moderate-to-severe opioid use disorder. To read the full article: Click Here How Opioids Started Killing Americans November 29, 2017Increasinglythan half of all people who succumbed to an overdose between 2001 to 2007 were chronic pain sufferers who filled an opioid prescription and sometimes plane saw a doctor in the month surpassing they died. Only 4 percent were overly diagnosed as having an vituperate problem, said Dr. Mark Olfson, one of five researchers who conducted a massive study of the slipperiness and its causes for Columbia University Medical Center. To read the full article: Click Here Too Difficult; You’ll Fail – The Difficult to Compound List November 6, 2017 There’s an initiative that’s been underway, for both 503A and B’s skills to be limited. If you’re not enlightened of the “difficult to compound” list and you’re a compounder, get out a paper and pen considering you’ll want to take some notes. This most recent list has been virtually increasingly or less since 2000, when the Pharmacy Compounding Advisory Committee submitted it to the FDA for consideration. The list included drugs and methods that prove to be “demonstrably difficult” to compound; ones that are so difficult that small compounding pharmacies shouldn’t attempt.  To read the full article: Click Here CDC tells OpioidTendencyStories with Message: ‘It Only Takes a Little to Lose a Lot’ November 3, 2017 The Centers for Disease Control and Prevention is telling the personal stories of people who were fond or knew someone who was fond to prescription opioids in a new wayfarers called Rx Awareness. The stories will be told through videos, radio spots, and social media, with the message that prescription opioids can be haunting and “it only takes a little to lose a lot.” To read the full article: Click Here What is Amazon Doing in Health and the Pharmacy Industry? October 31, 2017 Drug supply uniting expert Stephen Buck examines what Amazon is planning in health care. The reported pharmacy wholesale licenses that Amazon uninventive in 12 states is not a well-spoken signal that the visitor is inward the pharmacy or pharmaceutical distribution business. But if Amazon wants to enter the pharmaceutical distribution business, it would be easy to do so. To read the full article: Click Here Biocontainment: An Introduction to Control Levels & PracticalDiamondConcepts September 4, 2017 In part 1 of our vendible on biocontainment, we discussed the history of biocontainment as an outgrowth of medical research, expressly the effort to develop vaccines for various worldwide diseases. We provided some definition of the biosafety levels (BSLs) established by the Centers for Disease Control and Prevention (CDC) based on risk considerations. We moreover discussed the regulatory regime for biological teachers and, specifically, for designing a facility for an FDA or EU regulated product within the confines of the safety practices dictated by the CDC and diamond requirements of the NIH. To read the full article: Click Here State of Serialization: Where FDA & The Pharma Industry Currently Stand September 1, 2017 Serialization in the pharmaceutical sector is a uncontrived response to the problems of counterfeit, stolen, and gray-market drugs. There’s been a huge incentive for counterfeiters to indistinguishable high-profit-margin products. According to the 2016 Brand Protection and Product Traceability Market Research Report from PMMI, the woebegone market for unverified drugs is well-nigh $75 billion annually. A worthier issue for consumers, however, is that falsely labeled medicines can have a uncontrived impact on life and health. To read the full article: Click Here DYNALABS LLC is registered with the U.S. Food and DrugWardship(FDA), DEA and Bureau of Narcotics and Dangerous Drugs licensed, as well as ISO 17025 accredited. The products and services provided by DYNALABS are protected by U.S. Patent Nos. 7,197,405 and 7,660,678. © 2018 DYNALABS LLC. All Rights Reserved. For spare information well-nigh DYNALABS please undeniability 888-396-2522   •   info@dynalabs.usTerms Of Use   •   Privacy Policy   •   Customer Agreement