Are you seeking to master the intricacies of quality and compliance or looking to refine your existing expertise? Look no further! Whether you are new to quality and compliance or an experienced pro, our on-demand GxP Compliance and Technical training courses will give you the insight, tools, and techniques that you need to achieve success.

Our team of seasoned experts has developed educational courses to help you apply these essential concepts to your projects, allowing you to maximize the impact of your compliance and quality efforts. These courses also incorporate industry standards and best practices, such as those found in industry-leading technical reports and guidance documents from regulatory authorities.

Our Suite of Self-Paced GxP Compliance and Technical eLearning Courses

Our comprehensive suite of self-paced GxP Compliance and Technical eLearning training includes a variety of topics for individuals and teams alike. These courses cater to those seeking to deepen their expertise and fulfill annual training requirements. Courses length varies by topic but can range from 45-60 minutes each.

      • Mastering Your Change Control Process
        Understand the fundamentals, navigate regulatory landscapes, and discover best practices to ensure quality and compliance in regulated industries.
      • Fundamentals of Compliance Auditing
        Gain essential knowledge in the basics of GxP compliance auditing. Build your foundational understanding of audit requirements, methodologies, and effective auditor/auditee interactions
      • FDA Inspection Readiness – Pre-Approval Inspection (PAI) Overview
        Learn more about the basics of pre-approval inspections, including understanding what they are and why they are important to the ability for your organization to get your product into the US market.
      • FDA Inspection Readiness – Pre-Approval Inspection Behaviors and What to Expect
        Get insights into what happens during a PAI so that you can be prepared and better prepare your organization for the inspection.
      • FDA Inspection Readiness – Inspection Etiquette and SME Interview Skills
        Gain essential tips for interview success, covering ‘Inspection-Ready’ organization, impactful body language, and FDA interview techniques. Learn do’s and don’ts, interpret postures, and boost your preparedness.
      • FDA Pharmaceutical GMP – Modules 1 and 2
        These two modules together provide a well-rounded education in Good Manufacturing Practices, catering to both beginners and those looking to enhance their knowledge of GMP principles. Whether you are new to the field or aiming to reinforce your expertise, this course is your gateway to maintaining compliance and ensuring the highest quality standards in pharmaceutical manufacturing. Complete one or both online courses depending on your level of need.
      • Deviation Management – Part 1
        Understand the fundamentals of Deviation Management to effectively address unexpected process variations and seize opportunities for improvement.
      • Deviation Management – Part 2
        Learn how to effectively manage investigations and Root Cause Analysis activities as part of the DMAIC model in your deviation management program. Gain essential insights into how you can look beyond human error, aiming not just to correct deviations but to prevent them.
      • Deviation Management – Part 3
        Get insights into CAPA and Effectiveness Checks within Deviation Management by exploring the final phases of DMAIC, focusing on efficient CAPA processes. Learn to identify components of effective CAPA, recognize signs of inefficacy, and implement diverse approaches for improvement.
      • Internal Audits
        Explore key aspects of internal audits, beginning with their definition and objectives. Review relevant regulatory requirements and learn how to establish an effective internal audit program.
      • Mastering Quality Agreements
        Enhance your pharmaceutical and medical device compliance skills. Navigate regulatory complexities, learn effective negotiation, and stay ahead with insights into past observations. Elevate your expertise for compliance excellence.
      • Vendor Management Excellence
        Elevate your skills in vendor management. Explore key elements, regulatory compliance, and effective risk mitigation. Gain insights into Supplier Quality Assurance and Performance Monitoring. Learn to foster strong partnerships and ensure GMP compliance.
      • Intro to Good Pharmacovigilance Practices (GVP) – Module 1
        Explore the fundamental concepts, regulatory requirements, and best practices in pharmacovigilance, gaining insights into the processes that protect patient health by monitoring and managing drug safety risks. Get a solid understanding of GVP principles and the critical role they play in the pharmaceutical industry.
      • Intro to Good Pharmacovigilance Practices (GVP) – Module 2
        This continuation course explores the regulatory framework of Good Pharmacovigilance Practices (GVP), emphasizing guidelines that ensure drug safety and efficacy. It covers fundamental concepts, regulatory requirements, and best practices in pharmacovigilance.

More Topics Coming Soon!

    • Change Management
    • Vendor Qualification
    • Roles and Responsibilities of Quality Assurance
    • Data Integrity
    • Computer System Validation
    • Risk Management
    • MHRA GMP
    • EMA GMP
    • Process Validation
    • SOP/Technical Writing
    • Good Pharmacovigilance Practices (GVP)
    • Phase Appropriate GMP

Take your GxP compliance and technical skills to the next level. Group pricing is available. Contact us today for more information and to get registered.

 

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Webinars

Free Webinars. Enhance your skills without leaving your office. We know there is often a lack of training funds or time in your schedule to attend full days of training. So we've developed a suite of 60-90 minute free webinars, covering current software validation and quality assurance topics.