Good Laboratory Practices

Master Good Laboratory Practices (GLP): A Comprehensive Guide

This course provides a deep dive into Good Laboratory Practices (GLP), equipping you with the knowledge to ensure data reliability and regulatory compliance. We'll explore critical aspects of GLP, with a strong focus on data integrity within both analytical laboratories and microbiology laboratories.

Data Integrity: A Core Focus

• FDA & EU Citations: Understand the consequences of data integrity breaches and how to avoid them.
• Data Integrity – IT & Non-IT Focus: Explore the various facets of data integrity, encompassing both technological and procedural considerations.
• Data Integrity Examples: Learn practical examples of data integrity issues and how to address them.
• Inspector Trends: Stay ahead of the curve with insights into current inspection practices and what regulators are looking for.
• Microbiology Data Integrity: Specific examples and challenges related to maintaining data integrity in microbiology labs.
• Data Integrity Guidelines: A thorough review of different guidelines governing data integrity.
• FDA Warning Letter Evaluation: Learn how to evaluate FDA warning letters related to data integrity and conduct effective assessments.
• ALCOA+ Concept: Master the ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) for robust data management.
• Common Data Integrity Examples: Recognize and prevent common data integrity pitfalls.
• Audit Trails in Microbiology: Implement effective audit trails for enhanced data traceability.

Analytical Method Validation & Stability Studies

This course delves into essential analytical techniques and their validation:

• Analytical Method Validation: Meet FDA expectations for analytical method validation.

• Quality by Design (QBD): A brief overview of the QBD approach.

• Practical Validation Approach: Learn a practical, step-by-step approach to method validation.

• Quality Risk Management (QRM): Understand the role of QRM in analytical method validation.

• ICHQ14: Brief information on ICH Q14 – Analytical method development.

• ICHQ2(R1): Detailed coverage of ICH Q2(R1) – Analytical method validation.

• Validation Parameters: A comprehensive understanding of all key validation parameters.

• Revalidation Criteria: Learn when and how to revalidate analytical methods.

• Stability Studies: Understand the principles and requirements of stability studies.

• Out-of-Specification (OOS) Investigations: Learn how to effectively investigate and manage OOS results.

• Out-of-Trend (OOT) Investigations: Master the process of investigating and resolving OOT trends.

Troubleshooting & Human Error

• Analytical Laboratory Problem Solving: Develop effective problem-solving skills for common analytical laboratory challenges.
• Human Error Investigation: A dedicated lecture focusing on different types of human errors, investigation techniques, and preventative measures. Learn how to identify root causes and implement strategies to minimize human error in the lab.
• Sterility Testing: Understand when sterility tests can be repeated.

This course is designed for professionals seeking to enhance their understanding of GLP principles, improve data quality, and ensure regulatory compliance in analytical and microbiology laboratories.