How To Write An SOP Training Course

• 1-Day Course
• Webinar or Face to Face (F2F) Learning
• Expert Trainer With Actual SOP Writing Experience in the Life Science Industry

This 1-Day interactive course aims to provide the knowledge and skills required to write comprehensive and suitable Standard Operating Procedures (SOPs) to the required standard for regulatory authority inspections.

Learning Outcomes

In this course students will learn about essential concepts and practices to ensure that SOPs are produced to the required standard for regulatory authority inspection. The ultimate learning goal is to equip students with the knowledge and skills to create effective and suitable procedures that promote consistency of approach, and ultimately help to ensure patient safety. The learning outcomes below are intended to provide a comprehensive understanding of SOPs and equip students with the practical skills required to create effective procedures.

Understand The Importance Of SOPs In The Life Science Industry:

• Understand the advantages and disadvantages of following suitable SOPs.
• Gain familiarity with Life Science regulatory requirements and guidelines governing the requirements for suitable SOPs, such as FDA regulations, ISO standards, GMP (Good Manufacturing Practice), etc.
• Explore techniques for ensuring SOP compliance and adherence.
• Learn from real inspection outcomes where SOPs have been cited during regulatory inspections.
• Understand the role of SOPs in Quality Management Systems (QMS) and regulatory compliance.
• Learn about real impacts poor SOPs can have on product quality, regulatory compliance, and ultimately patient safety.
• Gain insights into best practices for SOP documentation, organisation and management.
• Learn how to incorporate feedback and continuous improvement into SOP development processes.
• Assess the effectiveness of SOPs and identify areas for improvement.
  

Gain SOP Generation, Completion, Approval And Management Skills:

• Identify the key components of an effective SOP.
• Gain the ability and skills to target SOPs towards a specific audience.
• Learn how to create, review and approve suitable SOPs following 5 easy steps.
• Develop skills in writing clear, concise, and actionable SOPs.
• Re-enforce your learning during a practical exercise, by practising writing an SOP for a given scenario and process.
• Understand how to apply SOP generation principles to everyday work activities, to ensure compliance and contribute to a culture of quality and continuous improvement.

Target Audience

This course will be of great value to anyone currently working in the Life Science Industry, or any other highly regulated and proceduralised industry that is subject to regulatory inspections.

Examination

The course is concluded with an optional examination.