CEU Credits: 0.1
Course Code: ELM-126
Duration: 60 mins
Skill Level: Basic
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.1
Effective Date: 08/11/2021
Curriculum for this course
Overview
Learning objectives
Who should take this course?
Course modules
What is a standard operating system
Regulatory requirements
Good Laboratory Practice (GLP)
GLP in the US
GLP in the US - Part 1
GLP in the US - Part 2
GLP in the US - Part 3
SOP requirements for ISO 17025
Good Manufacturing Practice (GMP)
Good Manufacturing Practice (GMP) – Continued
SOP requirements for ISO 9001
Summary of regulatory requirements for SOPs
Overview
Purpose
Scope
Equipment, materials and tools
Warnings and safety information
Glossary of terms
Roles and responsibilities
Procedure – List format
Procedure – Paragraph format
Policies, guidelines and references
Revision history
Attachments
Sign off
SOP life cycle
Stage 1: Initiation
Stage 2: Drafting the new SOP
Stage 2: Drafting the new SOP – continued
Stage 3: Reviewing the SOP
Stage 4: Approval of SOP
Stage 5: Revision of SOPs – Part 1
Stage 5: Revision of SOPs – Part 2
Stage 6: Decommissioning of SOPs
The requirements
Control of paper SOPs
Control of SOPs using electronic document management systems (EDMS)
Numbering of Standard Operating Procedures – Part 1
Numbering of Standard Operating Procedures – Part 2
Numbering of Standard Operating Procedures – Part 3
SOP training
Conclusion
Final Assessment
Certification
