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Good Laboratory Practices
Rating: 3.8 out of 5(95 ratings)
381 students

Good Laboratory Practices

This course will make you understand about different aspects of good laboratory practices.
Created byHitendrakumar Shah
Last updated 8/2021
English
English [Auto],

What you'll learn

  • This course has been created for all pharmaceutial professionals to learn Good Laboratory Practices
  • For completing this course, the attendee need to spare approx 10 hours and invest appro 1600 INR
  • Not applicable
  • The whole course will provide you certification on,"Good Laboratory Practices"

Course content

1 section • 6 lectures • 9h 41m total length

  • Introduction10:11

    Explore the fundamentals of good laboratory practices by examining stability studies, regulatory expectations, and the design of a robust stability testing program that supports shelf life and labeling.

  • Data Integrity in Analytical Laboratories1:56:31

    Develop data integrity in analytical laboratories by applying ALCOA plus principles, audit trails, and change controls. Gain practical insights into electronic systems, records, and regulator expectations.

  • Data Integrity in Microbiology Laboratories1:41:34

    Learn data integrity in microbiology laboratories, emphasizing ALCOA+ (attributable, legible, contemporaneous, complete, consistent, enduring, available), audit trails, contemporaneous records, and management escalation to prevent manipulation.

  • Out of Specification and Out of Trend investigations1:48:10

    Explore out of specification and out of trend investigations under FDA guidelines, covering retesting, resampling, root cause analysis, and required follow-up documentation.

  • Human Error Investigation and Reduction strategies1:49:55

    Investigate human error to uncover root causes, not assign blame, using the Swiss cheese model and root-cause analysis to implement corrective actions and strengthen good laboratory practices.

  • Analytical Method Validation2:15:08

    Learn how analytical method validation ensures accuracy, precision, specificity, LOD/LOQ, linearity, and robustness within a quality by design framework, aligning with regulatory expectations for pharma methods.

Requirements

  • The attendees should learn in focussed way and while learning, care should be taken not get disturbed and if required, while learning, the attendee can take notes.

Description

This course will make you understand about different aspects of good laboratory practices. The first aspect will include data integrity in analytical laboratory and microbiolgy laboratory. This will mainly focus on FDA/EU Citations,Non IT – Focus area for data integrity, IT- Focus area for data integrity,Some examples of data integrity,Current trends of inspectors,Data integrity in Microbiology laboratories – Some examples etc. Furthermore, attendees will learn about Different guidelines on Data Integrity, Evaluation of FDA warning letter and assessment,Understanding ALCOA+ concept, Common examples of data integrity,Audit Trail in microbiology, Sterility Test – When we can repeat and many more.

Further this good laboratory practices session will take you through analytical method validations, stability studies, out of specification and out of trend investigations and the most common problems solving in analytical laboratories. The analytical method validation comprises of FDA expectations about analytical method, Brief on QBD approach,How practically approach for validation,Role of QRM in analytical method validation,Brief information on ICHQ14 - Analytical method development,Detailed on ICHQ2(R1) – Analytical method validation,Understanding of all validation parameters,Overall evaluation and Revalidation criteria

The most common problem in analytical laboratories is human error investigation. Many errors are identified as human errors. This course is having specific one lecture which will focus on learning about different types of human errors and how to investigate and avoid the human errors.

Who this course is for:

  • This Training Course will benefit all who are working in pharmaceutical industries. Those who are auditors, participating in validation, quality control, production, compliance and ensure process and product improvement etc. QA/ QC Regulatory Affairs Project Managers Validation personnel Compliance personnel Auditors Personnel involved in QMS

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