dynalabs.us - Frequently Asked Questions

Frequently Asked Questions - DYNALABS

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Frequently Asked Questions - 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 | What We Do | Frequently Asked Questions Frequently Asked Questions What is a Batch Size? A batch size is the total value of material you specifically created, in which samples are pulled from and shipped to be tested Why didn’t my packing slip print? The most worldwide reason for a packing slip not to print is that your computer is blocking pop ups. Make sure to enable pop-ups for dynalabs.us. Your printer may not be on or unfluctuating to your computer What can rationalization my sterility tests to have an Indeterminate – Turbid result? Sample contaminated – Sample is plated day turbidity is observed. Plate is incubated. If no growth is observed, sample is transferred on day 14, then incubated for 4 spare days. Final result will be on day 18. If growth is observed on the plate, sample will be updated as positive. Sample reaction with media causes turbidity – Sample is transferred on day 14, then incubated for 4 spare days. Final result will be on day 18. Sample falling out of solution – Sample is plated day turbidity is observed. Plate is incubated.  If no growth is observed, sample is transferred on day 14, then incubated for 4 spare days. Final result will be on day 18. If growth is observed on the plate, sample will be updated as positive. Sample form is turbid in nature – Sample is transferred on day 14, then incubated for 4 spare days. Final result will be on day 18. How much does testing cost? We have three service levels, which detail variegated turnaround times based on your pharmacy’s needs. Once a service level is chosen, our Pricing Guide can be reviewed for pricing.  Please contact your Regional Sales Manager and/or Customer Support Specialist for increasingly information. Who can I contact for increasingly information? West Coast RegionalMerchantryManager: Christine Versichele | 714-300-3386 | cversichele@dynalabs.us Customer Support Specialist: Kris Johnson | 314-833- 2320 | kjohnson@dynalabs.us Midwest RegionalMerchantryManager: Kelly Shake | 314-346-4882 | kshake@dynalabs.us Customer Support Specialist: Claire Zielinski | 314-833- 2385 | czielinski@dynalabs.us Northeast RegionalMerchantryManager: Jeff Duperval | 516-965-0636 | jduperval@dynalabs.us Customer Support Specialist: Jacob Diamond | 314-833-2343 | jdiamond@dynalabs.us Southeast RegionalMerchantryManager: Meagan Arnett | 281-515-8001 | marnett@dynalabs.us Customer Support Specialist: Jon Bollwerk | 314-833-2378 | Jbollwerk@dynalabs.us Southwest RegionalMerchantryManager: Meagan Arnett | 281-515-8001 | marnett@dynalabs.us Customer Support Specialist: Tina Palmer | 314-833-2393 | tpalmer@dynalabs.us Where is your API list? http://www.dynalabs.us/products-services/api-list How much sample should I send in? While inward information on our Test Request Form, click the “review amounts required” sawed-off and all necessary amounts will towards You can moreover find Sample Submission requirements at the pursuit website for potency, sterility, endotoxin, particulate, pH, and specific gravity testing. http://www.dynalabs.us/products-services/sample-submission Can I just send in 1 sample for multiple tests? No, each test requires a unique container, sometimes multiple containers Is DYNALABS’ website HIPAA and/or GDPR compliant? DYNALABS does not collect, process, or store personal information of any kind. Therefore, DYNALABS does not fall under the regulatory requirements for either HIPAA (Health Information Portability and Accountability Act of 1996), or for GDPR (General Data Protection Regulation) in the European Union. DYNALABS maintains an ongoing Data Integrity Program to ensure industry weightier practices for enterprise security. What are the regulatory requirements for DYNALABS information security? DYNALABS is regulated by the FDA (Food and Drug Administration). We are governed by both 21 CFR Part 11 for data integrity and by the FDA GAMP (Good Automated Manufacturing Practices) requirement for software validation. DYNALABS maintains an ongoing Data Integrity Program to ensure that we maintain regulatory compliance with 21CFR Part 11, and that we maintain a level of enterprise security that is resulting with industry weightier practices. DYNALABS LLC is registered with the U.S. Food and Drug Administration (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