Lab Quality Management

Documentation

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Course overview
Are you ready to enhance your lab’s documentation practices and ensure full compliance? Welcome to the Documentation course, where you’ll learn the foundational principles and best practices for effective documentation in laboratory settings. Led by industry expert Dan Zuccarello from RBF Consulting Group LLC, this course provides lab leaders with essential knowledge and tools to maintain accurate and reliable records, improving both lab operations and regulatory compliance.
  • Area of Study

    Lab Quality Management

  • Course Duration

    1 hour

  • CEUs

    0.1

    This course is part of the Lab Quality Management Certificate. Looking to enroll in the full certificate?

    What is this course about?

    This course delves into the principles of good documentation practices (GDP), utilizing the ALCOA++ framework to emphasize accuracy, completeness, and traceability. You’ll explore key aspects like recordkeeping, document retention, and validation of digital records, providing you with a solid foundation to manage documentation in both physical and digital formats.

    Whether your lab deals with pharmaceuticals, food, or research data, this course ensures you’re equipped with actionable insights to enhance data integrity.

    What are the benefits of this course?

    • Implement Good Documentation Practices (GDP): Learn the core elements of GDP and how to apply them to your lab’s records for improved reliability and consistency.
    • Master the ALCOA++ Framework: Understand the principles of attributable, legible, contemporaneous, original, accurate, and more to uphold data integrity.
    • Ensure Compliance with Document Retention Standards: Gain insights into maintaining records that meet both internal policies and external regulatory requirements.
    • Validate Digital Records and Spreadsheets: Explore best practices for validating digital records, ensuring accurate data management for your lab’s electronic systems.
    • Protect Your Lab’s Data Integrity: Establish documentation practices that safeguard against errors and ensure data accuracy for audits and regulatory inspections.

    What are the learning outcomes of this course?

    By the end of this course, engaged learners should be able to:

    • Define good documentation practices (GDP) and apply them effectively within a lab setting
    • Describe the ALCOA++ framework and its role in ensuring data integrity
    • Establish compliant document retention processes, maintaining both physical and digital records
    • Identify best practices for validating digital records and spreadsheets
    • Implement documentation practices that reinforce data integrity and support regulatory compliance

    Ready to elevate your lab’s documentation standards?

    Enroll today and gain the skills needed to manage documentation that supports both operational efficiency and regulatory readiness.

    Meet The Instructor

    Dan Zuccarello

    MBA

    Years of Experience
    Dan Zuccarello currently serves as principal consultant for RBF Consulting Group, LLC located in Hightstown New Jersey. During his 40+ year career in industry, Dan has established and managed pharmaceutical, food, and petrochemical laboratories. Currently he provides consultation services for subject matters such as: computer system validation, elemental impurities, extractables and leachables (EL), ICH stability, expiry dating, product development (R&D), quality management systems, safety, and waste management. He has published and presented several papers on extractables and leachables and elemental impurities. He holds a BA degree from the University of Delaware and an MBA from Rutgers Graduate School of Business–Camden New Jersey.

    Course Content

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    What are the unique features of this course?

    Our Lab Quality Management courses will equip you with the essential skills and knowledge to implement and manage quality systems that ensure compliance, continuous improvement, and operational excellence in your lab(s).

    Self-paced Courses

    Each lecture video features supporting slides, skill-testing activities, interactive elements, and a short quiz.

    IACET Accreditation

    Each Lab Quality Management course is accredited by IACET and is worth 0.1 CEUs.

    Comprehensive Content

    We offer a variety of lab quality courses designed to provide in-depth knowledge and hands-on strategies for implementing and maintaining quality in laboratory settings.
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    IACET Accredited

    Lab Manager Academy is accredited by the International Accreditors for Continuing Education and Training (IACET) 
    We offer IACET CEUs for its learning events that comply with the ANSI/IACET Continuing Education and Training Standard. IACET is recognized internationally as a standard development organization and accrediting body that promotes quality of continuing education and training.