Regulatory Compliance Videos
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We Are Asymchem
8/30/2021
We're a CDMO that researches the possibilities, develops new technologies, and applies new processes in a continual drive toward optimization.
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Aseptic Vial Filling
6/18/2021
We offer a unique range of formulation and aseptic filling in vials, prefilled syringes or cartridges to address production needs that span from small early stage clinical products to larger scale commercial products.
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Using Egnyte For Life Sciences As GxP Repository
1/6/2021
Transitioning from the research phase to the clinical trial phase is a big step for any company, but it also means challenges, not the least of which means your electronic records need to comply with FDA 21 CFR Part 11 and GxP. In this democast, we will review how to deploy and use a GxP-compliant repository using Egnyte’s industry-focused platform, Egnyte for Life Sciences, without sacrificing usability or security, and without creating administrative overhead.
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Faciliflex Cleanroom Module For Therapeutic Drug Manufacturing
1/4/2021
The Faciliflex Module is a transformational new concept in designing cleanrooms for the production of lifesaving therapeutics.
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Your Contract Manufacturer Partner
12/14/2020
We offer a broad range of manufacturing services and capabilities to produce high-quality devices.
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GxP Audit Trails For FDA Compliance
12/8/2020
Many companies struggle with ensuring a strong compliance envelope as they transition from an R&D culture to a more-structured, regulated one. In this video we will cover Egnyte for Life Sciences platform overview focusing on audit trails, versioning, and reporting capabilities that can help you overcome your compliance challenges.
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Complimentary Workshop: EU Product Launch - Key Timeline Milestones From PhIII To Launch
7/17/2019
Launching a product into Europe but unsure about the different requirements for a European market? Join our experts in September at our EU Product Launch Workshop series: Key timeline milestones from phase 3 to launch, where they will guide you through an EU product launch.
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Pharmaceutical Coding Technologies For Serialization Compliance
6/19/2017
Coding for Compliance Domino prepares you for ePedigree.
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Cold Chain Expertise For Pharma And Biotech Firms In Regulatory And Quality
8/16/2016
PCI is a market leader in the provision of Cold Chain management services and has extensive capacity and unrivaled expertise to accommodate our client’s refrigerated and frozen storage and distribution requirements.Our extensive Cold Chain storage areas are all fully validated, continuously monitored and alarmed, and offer different storage temperatures, from Controlled Ambient (15-25°C) right down to -196°C.
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Cold Chain Services: Understand & Ensure Compliance
1/31/2013
ShockWatch specializes in the identification, design and implementation of solutions for all cold chain related issues.