CEU Credits: 0.1
Course Code: ELM-202
Duration: 30 mins
Skill Level: Basic
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.0
Curriculum for this course
Overview
Learning objectives
Who should take this course?
Program introduction
Module overview
Overview
What is quality management?
Standard operating procedures (SOP's)
Quality objective
GMP as a part of quality assurance
Requirements for an effective quality assurance program
ICH Q10
Life cycles phases of GMP
Overview
Premises
Production areas
Changing rooms
Storage areas
Quality control areas
Overview
Personnel
General principles
Special requirements for staff
Grades A,B,C and D
Personal hygiene
General considerations for manufacturing
Review Activity
Conclusion
Conclusion
Final Exam
Certification
Updated learning objectives to align with the course concepts and content. Removed the "Module 1 - The Starting Line" content from the course due to being repetitive of the content in ELM-201 - cGMP Cases From History and the Regulations.Updated the final exam with new questions to assess mastery of the updated learning objectives. Updated the final exam to create a question pool. The course will randomly select at a 3:1 ratio for a total of 10 assessment questions on each final exam attempt.
V2.0
