Organisation and Roles for 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
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