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  • WEBINARS/eLEARNING
    • Live Courses/Webinars
    • On-Demand Courses/Webinars
    • By Category
      • Clinical Trials (GCP)
      • Manufacturing
      • Medical Devices
      • Regulatory
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    • eLearning
      • Clinical Pathways
      • DIGR-ACT: Critical Thinking Skills for Clinical Trials
    • LSTI Learning Library
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    • Checkout
  • Custom Training
    • Live Training
    • Elearning Solutions
    • LSTI Corporate Learning Library
    • CRA Academy
  • Articles & Resources
  • About LSTI
    • LSTI Leadership
    • LSTI Instructors
    • Contact Us
    • Connect with LSTI
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An Introduction To Quality Agreements For Pharmaceutical Outsourcing

Any time a contractor or CMO is used, including arrangements between different divisions of the same company, regardless of the location of the parties involved, there should be a quality agreement in place.

Posted in: Manufacturing,
Tags: CGMP, CMO, ICH guidance, quality agreements,
How To Choose The Right Contract Laboratory For Your Drug Product

Finding a contract laboratory to fit the needs of your product is often challenging. Especially in the clinical and preclinical space, laboratory support is critical to presenting a foundation to the agency that your product is of the right quality and safety, and the basis of this before validation batches have been made depends wholly on the quality controls in place.

Posted in: Manufacturing,
Tags: CMO, GLP, GMP, laboratory,
Tips For Choosing The Right CMO For Your New Nanotech Drug Delivery System

It is difficult to be the pioneer seeking a partner who wants the opportunity to be on the cutting edge of new technology — and to participate in the future of medicinal chemistry.

Posted in: Manufacturing,
Tags: CMO, nanotechnology,
Considerations For Biologic Drug Substance And Drug Product Testing

Most manufacturing strategies today include some level of support from an outsourcing service provider such as a CMO or contract testing lab. There has been a great deal of discussion regarding the elevated role these providers play in the drug development process. Today’s CMO is likely to not only execute critical development activities but also provide insight based upon their own experiences with multiple processes.

Posted in: Manufacturing,
Tags: CMC, CMO, drug development, drug substance, DS,
3 Compelling Reasons To Form Strategic Partnerships With CDMOs

The past decades have seen a maturation of the contract manufacturing and development organization (CDMO) business and an increased level of collaboration between pharmaceutical companies and CDMOs. This article explores a number of drivers behind this trend.

Posted in: Manufacturing,
Tags: CDMO, CMO, supply chain,
What To Do When Your CMO Overpromises And Under-Delivers

You have struggled with your CMO for the last six months; slowly, but surely, your requested manufacturing dates for your newly transferred process have edged further and further out. You chose this CMO based on several factors: a capability match, good regulatory history, a passing quality systems audit, a capacity match, and their ability to meet your critical and aggressive timelines. Now, the looming reality is that your critical timeline will not be met, and you are struggling to get a believable commitment from the CMO so you can report back to your own organization.

Posted in: Manufacturing,
Tags: CMO, commitments, communication, completion, guidance, qualification,
4 Big Pharma Outsourcing Strategies That Work For Small/Virtual Companies

Being exposed to different CMOs during a well-structured bidding process will allow small and virtual pharma companies to assess what type of CMO would be the best fit for their business model.

Posted in: Clinical, Manufacturing,
Tags: audit, budget, CMO, proposal, supply,
What To Do When Your CMO Implements New Technology (That Impacts Your Product)

Your manufacturing CMO has just announced that it is preparing to implement a new technology that will improve quality and save time and money. Now, you just need to figure out if you are able to align the needs of your product or products and get on board with the change. Innovation and improvement efforts need to consider all aspects of the impact, including quality and regulatory considerations, supply constraints, market constraints, and cost.

Posted in: Manufacturing,
Tags: CMO, innovation, regulatory, validation,
10 Simple Steps To Selecting The Right CMO

While presenting a webinar on the CMO selection process not long ago, I had a moment of clarity. Even though I didn’t include the following words in 36-point block letters on any slide, I suddenly discovered the essence of the lecture

Posted in: Manufacturing,
Tags: CMO, strategy,
How To Prevent (Or Resolve) Communication Issues With Your CMO’s Project Manager

You are on your weekly project conference call with your CMO, discussing a product-filling project which is on track. The CMO’s project manager says, “Oh, I am going to go off agenda and ask for your signature by today to go forward with a machine-testing plan. If we don’t do it tomorrow, we might need to push your production run by a couple of weeks.” This is the first you have heard of it, so you are reacting on several levels.

Posted in: Manufacturing,
Tags: CMO, project management,

Upcoming Live Courses

  • China GCP 2020: Understanding and Implementing New Compliance Requirements
  • How to Prepare for FDA Guidance on Computer Software Assurance (CSA) in 2021 – A Two Part Primer
  • It is Finally Here! Update to the ISO Medical Device GCP Standard: ISO 14155:2020
  • Preparing for Changes to ICH GCP E6(R3) and ICH E8(R1) – Readying for Risk Mitigation

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About Us

The Life Science Training Institute helps pharma, biotech, and medical device companies build knowledgeable, compliant workforces by providing training from drug discovery through commercialization. We are dedicated to advancing careers of those working to develop new therapies and to protect patient safety.

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