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  • WEBINARS/eLEARNING
    • Live Courses/Webinars
    • On-Demand Courses/Webinars
    • By Category
      • Clinical Trials (GCP)
      • Manufacturing
      • Medical Devices
      • Regulatory
      • R&D
      • Leadership & Training
    • eLearning
      • Clinical Pathways
      • DIGR-ACT: Critical Thinking Skills for Clinical Trials
    • LSTI Learning Library
    • Training Voucher Packages
    • 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
    • Frequently Asked Questions
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10 Key Ingredients For Small Pharma GCP Quality Systems

Small to midsize pharmaceutical or biotech companies (small pharma) are enjoying the best of times. However, from a quality systems perspective, it could be the worst of times. Many have weak quality systems, are not following global regulatory authority regulations and/or guidance, or lack the level of documentation required to reconstruct every aspect of clinical trials.

Posted in: Clinical, Manufacturing,
Tags: big pharma, GCP, quality systems, small pharma, sponsors, vendor oversight,
The Value Of Standardizing Risk Assessment Across Quality Systems

In recent years, the trend in the pharmaceutical, biopharma, and device industries has been to devote more attention to holistic quality systems and to ensure standardization of the company’s overall quality systems rather than using process-by-process policies that may or may not align completely. The 2015 changes to ISO 9001 and ISO 14644-1 and -2 standards have magnified the industry’s focus on risk assessment and quality management systems, integrating and unifying our approach to ensuring quality across all aspects of pharmaceutical, biopharma, and medical device manufacturing.

Posted in: Manufacturing,
Tags: FMEA, QMS, quality management, quality systems, risk assessment,
How To Build A Value-Added GMP Supplier Management Program

Typically, supplier management programs use a supplier survey or an on-site audit to verify if a supplier is compliant with the requirements of a standard or regulation. However, for a supplier management program to provide added value to an organization, the supplier evaluation should look beyond the requirements of a standard or regulation. A value-added supplier management program should also consider items such as supplier capability, capacity, and contingency planning.

Posted in: Device, FDA, Manufacturing, Training,
Tags: GMP, ISO, purchasing, QMS, quality systems, supplier management program, suppliers,
Facilities And Equipment Risk Management: A Quality Systems Approach

This two-part article focuses on risk management of facilities and equipment. It describes how a risk-based approach to facilities and equipment management fits into an integrated, effective quality systems structure. The principles discussed are equally applicable to all quality systems. The focus is on facilities and equipment because they represent a broad range of risk to product quality and are one of the key quality systems commonly identified in the pharmaceutical manufacturing industry.

Posted in: Manufacturing,
Tags: HSE, quality systems, risk, safety,

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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