Lab Quality / Responsibilities of Quality Management

Documentation

Instructor: Dan Zuccarello

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.

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.

There is no description for this course

Course content

    • Introduction
    • ALCOA
    • Supportive Documentation Practices
    • Quiz