Course Information
A common root cause of failures in the performance of Quality Management Systems is poorly structured and worded Standard Operating Procedures (SOPs).
SOPs which are difficult to interpret and follow will lead to confusion and non-conformance. Corrective and preventative actions which require the re-writing of SOPs can be a lengthy time and resource consuming process. Getting it right the first time is vital.
The course content has been tailored for those who are responsible for writing or revising SOPs for the Quality Management Systems of pharmaceutical, biopharmaceutical and medical device manufacturing and other sectors related to biomedical science manufacturing.
The course will be useful for responsible persons involved in quality control, production, auditing and inspection, validation, quality assurance, process development, routine maintenance, commissioning and procurement.
Learning Outcomes
In this practice-based course, participants will learn the key elements of developing, structuring and writing SOPs which are easy to follow, interpret and maintain.
- How SOPs fit into the GMP framework
- Basic structure and key elements of an SOP
- How the process of writing an SOP affects its quality
- How empathy for users affects quality of SOP
- Content organisation
- Clear and concise writing
- Writing informative titles and action-oriented headings
Course
Schedule
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Course Date: 7 Jul 2022
Application Period: 4 May – 5 Jun 2022
Duration: 1 day (Wednesday)
Time: 9am to 6pm
Delivery Mode: Classroom
Venue: Ngee Ann Polytechnic
Ngee Ann Polytechnic reserves the right to reschedule / cancel any programme, modify the fees and amend information without prior notice.
Lesson Plan
Topic 1: SOPs and Good Manufacturing Practice (GMP) compliance
• How SOPs fit into the overall GMP framework?
• What are the key Food Drug Administration (FDA) and European Union (EU)
requirements related to SOPs?
• What are the qualities of a high-quality SOP?
Topic 2: Structure and process of writing SOPs
• SOPs: Three-part structure and key parts
• How the process of writing SOPs affects its quality?
Topic 3: Best writing practices (Part 1)
• How your empathy for the users affects the quality of SOP?
• How much detail?
• Content organisation: simple/hierarchical steps, graphical format and flow chart
• Clear, concise and precise writing
• Writing short sentences
• Using imperative sentences
• Being specific
• Using parallel phrasing
• Writing positive phrases
• Using acronyms and abbreviations with care
Topic 4: Best writing practices (Part 2)
• Writing informative title and action-oriented headings
• Ensuring consistency
• Reader-friendly formatting
• Using checklist to ensure quality
Certification
Certification
A Certificate of Performance will be awarded to participants who achieve at least 75% attendance and pass all required assessment(s).
Entry Requirements
Course Fees
SkillsFuture Credit
All Singaporeans aged 25 and above can use their $500 SkillsFuture Credit from the government to pay for a wide range of approved skills-related courses. Visit the SkillsFuture Credit website to choose from the courses available on the Training Exchange course directory.
Ngee Ann Polytechnic reserves the right to reschedule/cancel any programme, modify the fees and amend information without prior notice.
(Course fee is payable upon acceptance. It is inclusive of 7% GST and subject to review.)
| Applicants / Eligibility | Fees |
|---|---|
| Full course fees | $428.00 |