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Good Laboratory Practice Regulations and Compliance for Biotech Facilities

Good Laboratory Practice Regulations and Compliance for Biotech Facilities

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Good Laboratory Practice Regulations and Compliance for Biotech Facilities



Course Overview

This comprehensive course is designed to provide participants with a thorough understanding of Good Laboratory Practice (GLP) regulations and compliance requirements for biotech facilities. The course is interactive, engaging, and practical, with a focus on real-world applications.



Course Objectives

  • Understand the principles and regulations of Good Laboratory Practice (GLP)
  • Learn how to implement GLP in a biotech facility
  • Understand the importance of compliance with GLP regulations
  • Gain knowledge on how to conduct audits and inspections
  • Learn how to manage and maintain records and documentation


Course Outline

Module 1: Introduction to Good Laboratory Practice (GLP)

  • History and evolution of GLP
  • Principles of GLP
  • Importance of GLP in biotech facilities
  • Regulatory framework for GLP

Module 2: GLP Regulations and Guidelines

  • Overview of GLP regulations
  • US FDA GLP regulations
  • EU and OECD GLP guidelines
  • Comparison of GLP regulations across different regions

Module 3: Study Director and Study Personnel Responsibilities

  • Role and responsibilities of the Study Director
  • Responsibilities of study personnel
  • Training and qualification of study personnel
  • Communication and documentation

Module 4: Study Plan and Protocol

  • Development of a study plan and protocol
  • Content and format of a study plan and protocol
  • Review and approval of a study plan and protocol
  • Amendments to a study plan and protocol

Module 5: Conducting a GLP Study

  • Pre-study activities
  • Study initiation and conduct
  • Monitoring and controlling the study
  • Study completion and reporting

Module 6: Quality Assurance (QA) and Quality Control (QC)

  • Role of QA in GLP
  • QA activities and responsibilities
  • QC procedures and responsibilities
  • Auditing and inspection

Module 7: Record Keeping and Documentation

  • Importance of record keeping and documentation
  • Types of records and documentation
  • Management and maintenance of records and documentation
  • Retention and archiving of records and documentation

Module 8: Auditing and Inspection

  • Types of audits and inspections
  • Preparation for audits and inspections
  • Conducting audits and inspections
  • Responding to audit and inspection findings

Module 9: Compliance and Regulatory Issues

  • Compliance with GLP regulations
  • Regulatory inspections and audits
  • Common compliance issues
  • Corrective actions and CAPA

Module 10: Best Practices for GLP Compliance

  • Best practices for study planning and conduct
  • Best practices for QA and QC
  • Best practices for record keeping and documentation
  • Best practices for auditing and inspection


Course Features

  • Interactive and engaging: The course includes interactive elements, such as quizzes, case studies, and group discussions.
  • Comprehensive and up-to-date: The course covers all aspects of GLP regulations and compliance, and is updated regularly to reflect the latest developments.
  • Practical and real-world applications: The course includes real-world examples and case studies to illustrate the application of GLP principles.
  • Expert instructors: The course is taught by experienced instructors with expertise in GLP regulations and compliance.
  • Certification: Participants receive a certificate upon completion of the course, issued by The Art of Service.
  • Flexible learning: The course is available online, allowing participants to learn at their own pace and convenience.
  • User-friendly and mobile-accessible: The course is designed to be user-friendly and accessible on a variety of devices.
  • Community-driven: The course includes a discussion forum where participants can interact with each other and with the instructors.
  • Actionable insights: The course provides participants with practical insights and knowledge that can be applied immediately.
  • Hands-on projects: The course includes hands-on projects and case studies to help participants apply their knowledge.
  • Bite-sized lessons: The course is divided into bite-sized lessons, making it easy to fit into a busy schedule.
  • Lifetime access: Participants have lifetime access to the course materials.
  • Gamification: The course includes gamification elements, such as quizzes and challenges, to make learning more engaging.
  • Progress tracking: Participants can track their progress through the course.


Certificate of Completion

Upon completion of the course, participants will receive a certificate issued by The Art of Service. This certificate is a valuable recognition of the participant's knowledge and skills in GLP regulations and compliance.

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