Organization and Roles for the Regulated Laboratory
Description:
This course is intended for professionals and others who are employed in regulated (cGLP and current Good Manufacturing Practice) or accredited (ISO 17025) laboratories, and is intended to form a core training syllabus for laboratory management and scientific personnel.
Curriculum for this course:
Introduction
Overview | 2 min 10 secs |
Learning objectives | 2 min 20 secs |
Who should take this course? | 1 min 35 secs |
Course modules | 1 min 45 secs |
Module 1: Quality Control / Quality Assurance Regulations
Overview | 2 min 19 secs |
Laboratory management organization | 2 min 10 secs |
PIC/S & ICH Q9 Quality Assurance Department | 2 min 42 secs |
ISO-17025 Requirements for the Quality Assurance Department | 1 min 35 secs |
Good Laboratory Practice for Quality Assurance | 2 min 58 secs |
US cGLP requirements for the Quality Assurance Department | 1 min 35 secs |
Module 2: Laboratory Management Structure
Overview | 2 min 42 secs |
Fundamentals of laboratory management structure | 1 min 35 secs |
Acceptable management structures | 2 min 42 secs |
Unacceptable management structures | 2 min 42 secs |
Module 3: Roles and Responsibilities
Overview | 2 min 12 secs |
Responsibilities of the laboratory director | 2 min 09 secs |
Study director | 1 min 42 secs |
Roles and responsibilities of the study director | 2 min 42 secs |
Laboratory supervisor | 1 min 51 secs |
Analytical staff | 1 min 19 secs |
Laboratory support group | 2 min 42 secs |
Quality assurance personnel | 1 min 39 secs |
Review activity | 5 mins |
Module 4: Staff Training and Laboratory Independence and Impartiality
Overview | 1 min 39 secs |
Staff training | 2 min 22 secs |
Preserving the laboratory's independence and impartiality | 1 min 41 secs |
Module 5: Laboratory Infrastructure and Facilities
Overview | 2 min 11 secs |
Accomodation | 1 min 41 secs |
Laboratory instrumentation | 2 min 29 secs |
Utilities | 1 min 41 secs |
Review activity | 5 mins |
Conclusion
Final Assessment
Certification
Revision History
Course updated to v1.2 on 3/27/2023 to update player settings from dark mode to light mode | Version 1.2 |
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