How to Write Effective Standard Operating Procedures (SOPs)

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Description:

This course has been designed for anyone who wants to learn more about writing effective Standard Operating Procedures or SOPs specifically within the highly regulated life science industry. The course will not only serve those people working in the life science sector but also to other organizations operating a quality management system.

Curriculum for this course:

Introduction

Overview	1 min 20 secs
Learning objectives	1 min 09 secs
Who should take this course?	58 secs
Course modules	1 min 11 secs

Module 1: Regulatory Requirements

What is a standard operating system	1 min 33 secs
Regulatory requirements	1 min 22 secs
Good Laboratory Practice (GLP)	1 min 35 secs
GLP in the US	1 min 44 secs
GLP in the US – Part 1	1 min 09 secs
GLP in the US – Part 2	45 secs
GLP in the US – Part 3	1 min 51 secs
SOP requirements for ISO 17025	1 min 29 secs
Good Manufacturing Practice (GMP)	1 min 31 secs
Good Manufacturing Practice (GMP) – Continued	1 min 37 secs
SOP requirements for ISO 9001	1 min 16 secs
Summary of regulatory requirements for SOPs	1 min 11 secs

Module 2: Contents of a Standard Operating Procedure

Overview	1 min 02 secs
Purpose	1 min 21 secs
Scope	47 secs
Equipment, materials and tools	1 min 30 secs
Warnings and safety information	1 min 28 secs
Glossary of terms	37 secs
Roles and responsibilities	1 min 33 secs
Procedure – List format	1 min 05 secs
Procedure – Paragraph format	49 secs
Policies, guidelines and references	50 secs
Revision history	1 min 26 secs
Attachments	1 min 09 secs
Sign off	1 min 36 secs
SOP life cycle	1 min 47 secs
Stage 1: Initiation	53 secs
Stage 2: Drafting the new SOP	59 secs
Stage 2: Drafting the new SOP – continued	1 min 41 secs
Stage 3: Reviewing the SOP	1 min 37 secs
Stage 4: Approval of SOP	1 min 16 secs
Stage 5: Revision of SOPs – Part 1	1 min 24 secs
Stage 5: Revision of SOPs – Part 2	1 min 07 secs
Stage 6: Decommissioning of SOPs	1 min 04 secs

Module 3: Control and Management of Standard Operating Procedures

The requirements	1 min 07 secs
Control of paper SOPs	1 min 30 secs
Control of SOPs using electronic document management systems (EDMS)	1 min 38 secs
Numbering of Standard Operating Procedures – Part 1	1 min 10 secs
Numbering of Standard Operating Procedures – Part 2	1 min 40 secs
Numbering of Standard Operating Procedures – Part 3	1 min 09 secs
SOP training	1 min 02 secs