Life Science Training Institute - Training for GxP Professionals

Time 2021-01-13 07:03:19

Web Name: Life Science Training Institute - Training for GxP Professionals

WebSite: http://www.lifesciencetraininginstitute.com

ID:165572

Keywords:

Training,Science,Life,

Description:

Due to the ongoing restrictions caused by COVID-19, LSTI employees are working remotely.  If you have questions or concerns, please email info@lifesciencetraininginstitute.com and we will respond promptly.  Stay safe!Thanks to our relationship with LSTI and an outstanding team here at Accelovance, we have built a training program that is able to be leveraged moving forward to address an industry need. My main reason for taking the course was to re-evaluate quality agreements and how to improve our current template. Coming out of this, I would like to compare a few of our supplier quality agreements against the structure and checklist given in the course to see how they align.All parts of the training were useful, including the topics of Documentation, Change Control and Revisions. I will now review our current Quality Agreement to make sure the requirements are included, and if not, add them.I took the course to get a better understanding of FDA requirements. As an ISO 9001 registered organization, we need to control and cooperate with suppliers and this gave me some ideas on more formal ways to do that. The webinar was easy to attend with clear audio.A Quality Agreement Primer: Managing Risk When Working With ContractorsThis is part one of a three-part series that explores quality agreements, regulations, guidelines, and working with vendors to ensure quality expectations are met. Part one discusses identifying key risks in partnering with contract companies and working with vendors.Overcoming The Challenges Of Patient-Centric Specification SettingThe revolution in scientific knowledge that is bringing hope to patients with devastating diseases is also setting the stage for modernizing our approach to specifications and process control. Updating our approach to specification setting will accelerate the delivery of breakthroughs to patients.Capacity Competency Of The Clinical Research Workforce — Today TomorrowIt’s not simply an issue of supply and demand. It’s closer to life and death. Put bluntly, we may not be able to keep up with future clinical trial demand because our workforce isn’t growing fast enough. In fact, by some metrics, we’re already falling behind.Hazmat Regulations: What Life Sciences Companies Need To KnowIt is important for life sciences companies to understand the regulations laid out in the U.S. Department of Transportation’s 49 CFR Parts 100-185 — and their impact on package design and testing requirements, training requirements, and packaging and handling hazardous materials in bulk and non-bulk forms.COVID-19 s Impact On The Clinical Trial Ancillary Supplies IndustryWith restrictions on logistics, and countries implementing new restrictions to address increasing COVID-19 cases, it’s important to understand how to manage clinical trials’ ancillary supplies — like sourcing from the right suppliers, managing distribution to all trial sites, stock management, and response to new regulations.How To Generate The Right Input Data For An Effective Quality Management Review SystemThis article is the second in a two-part series about demonstrating CGMP compliance during inspections by establishing a successful quality culture and related systems. Part 1 discussed the importance of “top-down” quality management and “bottom-up” communication of compliance risks and concerns. Here in Part 2, we turn our attention to the input data for an effective QMR.We use cookies to ensure that we give you the best experience on our website. If you continue to use this site we will assume that you are happy with it.Ok

TAGS:Training Science Life 

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Life Science Training Institute (LSTI) provides training & consulting for GxP life science professionals and pharmaceutical, medical device, and biotech companies.

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