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._x000D_
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- 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
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Course
Schedule
Course Date: 25 Feb 2021_x000D_
Application Period: 19 Jan to 13 Feb 2021_x000D_
Duration: 1 day_x000D_
Time: 9am to 6pm_x000D_
Ngee Ann Polytechnic reserves the right to reschedule / cancel any programme, modify the fees and amend information without prior notice.
Lesson Plan
This course consists of 1 modules:
Topic 1: SOPs and Good Manufacturing Practice (GMP) compliance_x000D_
• How SOPs fit into the overall GMP framework?_x000D_
• What are the key Food Drug Administration (FDA) and European Union (EU)_x000D_
requirements related to SOPs?_x000D_
• What are the qualities of a high-quality SOP?_x000D_
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Topic 2: Structure and process of writing SOPs_x000D_
• SOPs: Three-part structure and key parts_x000D_
• How the process of writing SOPs affects its quality?_x000D_
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Topic 3: Best writing practices (Part 1)_x000D_
• How your empathy for the users affects the quality of SOP?_x000D_
• How much detail?_x000D_
• Content organisation: simple/hierarchical steps, graphical format and flow chart_x000D_
• Clear, concise and precise writing_x000D_
• Writing short sentences_x000D_
• Using imperative sentences_x000D_
• Being specific_x000D_
• Using parallel phrasing_x000D_
• Writing positive phrases_x000D_
• Using acronyms and abbreviations with care_x000D_
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Topic 4: Best writing practices (Part 2)_x000D_
• Writing informative title and action-oriented headings_x000D_
• Ensuring consistency_x000D_
• Reader-friendly formatting_x000D_
• Using checklist to ensure quality
Certification
A Certificate of Performance will be awarded to participants who achieve at least 75% attendance and pass all required assessment(s).
Course Fees
Course fee is payable upon acceptance. It is inclusive of 7% GST and subject to review._x000D_
The course is eligible for SkillsFuture Credit. For more information on the SkillsFuture Credit click here.
| Applicants / Eligibility | Fees |
|---|---|
| Singapore Citizens (SC) below the age of 40 years | $128.40 |
| Singapore Citizens (SC) aged 40 and above | $48.40 |
| Singapore Permanent Residents (PR) | $128.40 |
| Enhanced Training Support for SME Scheme (for SC & SPR) | $48.40 |
| Others (and Repeat Students) | $428.00 |
| Full Course Fee | $428.00 |